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33 Study Matches

Trial of Inhaled Molgramostim in CF Subjects With NTM Infection (ENCORE)

A study to evaluate the efficacy of inhaled molgramostim administered open-label to adult cystic fibrosis subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing antimycobacterial guideline based combination therapy.
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studyfinder@utsouthwestern.edu
Raksha Jain
19733
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03597347
STU-2019-0638
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Inclusion Criteria:
1. Written informed consent obtained from participant. 2. Confirmed diagnosis of CF according to the Cystic Fibrosis Foundation (CFF) 2017 Consensus Guidelines. 3. History of chronic pulmonary infection with M. avium complex (MAC) or M. abscessus complex (MABSC) (defined as at least three positive NTM cultures (sputum or BAL for the same species (MAC) or subspecies (MABSC) within the 2 years prior to the screening visit, with at least one positive within the past 6 months and a minimum of 50% of NTM cultures positive over the past 2 years) that does not demonstrate response to current treatment course based on decreasing NTM burden or frequency of positive cultures, and in the opinion of the Investigator is unlikely to resolve with current treatment course. 4. Subject fulfills criteria for inclusion in one of the following groups: Group 1: Subject with chronic pulmonary MAC or MABSC infection currently on a multidrug NTM guideline-based antimycobacterial regimen, which has been ongoing for at least 9 months prior to the Baseline visit. Group 2: Subject with chronic pulmonary MAC or MABSC infection who has stopped a multidrug NTM guideline-based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance. Group 3: Subjects with chronic pulmonary MAC or MABSC infection not meeting recommendations for treatment with a multidrug NTM guideline-based antimycobacterial regimen based on failure to meet ATS/IDSA criteria for NTM pulmonary disease (i.e. absence of radiologic findings and clinical symptoms beyond what is expected from underlying CF). 5. Ability to produce sputum or be willing to undergo an induction protocol that produces sputum for clinical evaluation. 6. An additional sputum culture performed by the central laboratory, which is positive for the same species (MAC) or subspecies (MABSC) of NTM as before the trial within 10 weeks of Baseline. 7. CF which in the Investigator's opinion is clinically stable and not expected to require lung transplantation within the next year. 8. FEV1 ≥ 30% of predicted at screening that is normalized for age, gender, race, and height, using the Global Lung Function Initiative (GLI) equation. 9. Subjects who are co-infected with a respiratory pathogen, e.g. P. aeruginosa or S. aureus, must either be stable on a regular suppression antibiotic regimen or must be, in the opinion of the Investigator, stable despite the lack of such treatment. 10. Female or male ≥18 years of age. 11. If female, subjects who have been post-menopausal for more than 1 year or females of childbearing potential after a confirmed menstrual period using a highly efficient method of contraception (i.e. a method with less than 1% failure rate) during and until 30 days after last dose of trial treatment, having a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at dosing at Baseline (Visit 2) and must not be lactating. For purposes of this study, the Sponsor defines "acceptable methods of contraception" as:
• Oral birth control pills administered for at least 1 monthly cycle prior to administration of the study drug.
• A synthetic progestin implanted rod (eg, Implanon®) for at least 1 monthly cycle prior to the study drug administration but not beyond the 4th successive year following insertion.
• Intrauterine devices (IUDs), inserted by a qualified clinician for at least 1 monthly cycle prior to study drug administration.
• Medroxyprogesterone acetate (eg, Depo-Provera®) administered for a minimum of 1 monthly cycle prior to administration of the study drug and continuing through 1 month following study completion.
• Hysterectomy or surgical sterilization.
• Vasectomized partner
• Abstinence. Double barrier method (diaphragm with spermicidal gel or condoms with contraceptive foam) is not considered an acceptable form of contraception. NOTE: For subjects prescribed Orkambi: Orkambi may substantially decrease hormonal contraceptive exposure, reducing the effectiveness and increasing the incidence of menstruation-associated adverse reactions. Hormonal contraceptives, including oral, injectable, transdermal, and implantable, should not be relied upon as an effective method of contraception when co-administered with Orkambi. 12. If male, subjects who, if sexually active of reproductive potential and non-sterile (i.e., male who has not been sterilized by vasectomy for at least 6 months and not diagnosed with infertility through demonstration of azoospermia in a semen sample and/or absence of vas deferens through ultrasound) are willing to use a barrier method of contraception, or their female partner must use an acceptable method of contraception, during the study and until 30 days after last dose of medication. 13. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures specified in the protocol as judged by the Investigator. Exclusion criteria: 1. Use of non-maintenance antibiotic for a concurrent pulmonary or extrapulmonary infection within 28 days prior to the Baseline visit. 2. Use of a maintenance antibiotic regimen containing azithromycin for a concurrent non-NTM pulmonary infection within 28 days prior to the Baseline visit. For subjects in Group 1, azithromycin is allowed if part of ongoing multidrug NTM guideline-based antimycobacterial regimen. 3. Prior therapy with inhaled or systemic granulocyte macrophage colony stimulating factor (GM-CSF). 4. Subjects with hemoptysis of ≥60 mL in a 24-hour period within 4 weeks prior to Screening. 5. Life expectancy of less than 6 months according to Investigator's judgement. 6. History of, or present, myeloproliferative disease, leukemia or other hematological malignancy. 7. Active pulmonary malignancy (primary or metastatic); or any malignancy requiring chemotherapy or radiation therapy within 1 year prior to Screening or anticipated during the study period. 8. Active autoimmune disorder or other condition requiring therapy associated with significant immunosuppression, e.g. such as systemic corticosteroids at a dose equivalent of 10 mg/day or more of prednisolone or other significant immunosuppressant medications, within 3 months prior to Screening or anticipated during the study period. Inhaled or topical corticosteroids, or brief courses (<14 days) of systemic corticosteroids for pulmonary exacerbations or other self-limited conditions are permitted. 9. Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid medications, or changes in Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulators, within 28 days prior to the Baseline visit. 10. Pulmonary tuberculosis requiring treatment or treated within 2 years prior to Screening. 11. History of human immunodeficiency virus (HIV) infection or other disease associated with significant immunodeficiency. 12. History of lung or other solid organ transplantation or currently on the list to receive lung or other solid organ transplantation. 13. History of congestive heart failure (CHF) New York Heart Association (NYHA) Class III or greater in severity. 14. History of cardiovascular ischemic event within 6 months of Baseline. 15. Any change in chronic NTM multi-drug antimycobacterial regimen within 28 days prior to Screening. 16. Treatment with any investigational medicinal product within 28 days of Screening. 17. Previous experience of severe and unexplained side-effects during aerosol delivery of any kind of medicinal product. 18. Any other condition that, in the opinion of the Investigator, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Drug: Molgramostim nebulizer solution, Device: PARI eFlow nebulizer system
Cystic Fibrosis (CF), Mycobacterium Infections, Nontuberculous, Lung/Thoracic
Nontuberculosis mycobacterial (NTM) infection, Cystic Fibrosis (CF), M. avium complex (MAC), M. abscessus complex (MABSC), Mycobacterium Infections, Nontuberculous
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Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

The purpose of this study is to compare the efficacy of maribavir to investigator-assigned anti-Cytomegalovirus (CMV) therapy in CMV viremia clearance in transplant recipients who are refractory or resistant to prior anti-CMV treatment.
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studyfinder@utsouthwestern.edu
Ricardo La Hoz
158414
All
12 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT02931539
STU 052017-038
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Inclusion Criteria:
1. The participant must be able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures. As applicable, a parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the participant before completing any study-related procedures. 2. The participant must be a recipient of hematopoietic stem cell or solid organ transplant. 3. The participant must have a documented CMV infection in whole blood or plasma, with a screening value of greater than or equal to (>=) 2730 international units per milliliter (IU/mL) in whole blood or >= 910 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by local or central specialty laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to randomization with second sample obtained within 5 days prior to randomization. The same laboratory and same sample type (whole blood or plasma) must be used for these assessments. 4. The participant must have a current CMV infection that is refractory to the most recently administered of the four anti-CMV treatment agents. Refractory is defined as documented failure to achieve greater than (>) 1 log10 (common logarithm to base 10) decrease in CMV DNA level in whole blood or plasma after a 14 day or longer treatment period with intravenous (IV) ganciclovir/oral valganciclovir, IV foscarnet, or IV cidofovir. a. Participants with documentation of 1 or more CMV genetic mutations associated with resistance to ganciclovir/valganciclovir, foscarnet, and/or cidofovir must also meet the definition of refractory CMV infection. 5. The Investigator must be willing to treat the participant with at least one of the available anti-CMV drugs (ganciclovir, valganciclovir, foscarnet, or cidofovir). Note: Combination therapy with foscarnet and cidofovir is not permitted in the investigator-assigned anti-CMV treatment (IAT) arm due to the potential for serious nephrotoxicity. 6. The participant must be >= 12 years of age at the time of consent. 7. The participant must weigh >= 35 kilogram (kg). 8. The participant must have all of the following results as part of screening laboratory assessments (results from either the central laboratory or a local laboratory can be used for qualification): 1. Absolute neutrophil count (ANC) >= 1000/ millimeter cube (mm^3) (1.0 x 10^9/liter [L]) 2. Platelet count >= 25,000/mm^3 [25 x 10^9/L], 3. Hemoglobin >= 8 grams per deciliter (g/dL). 4. Estimated glomerular filtration rate (eGFR) > 30 (milliliters per minute (mL/min) /1.73 square meter (m^2) as assessed by Modification of Diet in Renal Disease (MDRD) formula for participants >= 18 years of age or Schwartz formula for participants less than (<) 18 years of age. 9. The participant must have a negative serum beta-human chorionic gonadotropin (beta-HCG) pregnancy test at screening, if a female of child bearing potential. Additional urine pregnancy tests may be done per institutional requirements. Sexually active females of child bearing potential must agree to comply with any applicable contraceptive requirements of the protocol. If male, must agree to use an acceptable method of birth control, as defined in the protocol, during the study treatment administration period and for 90 days afterward if treated with maribavir, ganciclovir, valganciclovir, or cidofovir and for 180 days afterward if treated with foscarnet. 10. The participant must be able to swallow tablets, or receive tablets crushed and/or dispensed in water via nasogastric or orogastric tube. 11. The participant must be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol. 12. The participant must be willing to provide necessary samples (example [e.g,] biopsy) for the diagnosis of tissue invasive CMV disease at baseline as determined by the Investigator. 13. The participant must have a life expectancy of >= 8 weeks.
Exclusion Criteria:
1. Have a current CMV infection that is considered refractory or resistant due to inadequate adherence to prior anti-CMV treatment, to the best knowledge of the Investigator. 2. Require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for conditions other than CMV when study treatment is initiated (example: herpes simplex virus (HSV) coinfection requiring use of any of these agents after the randomization) or would need a coadministration with maribavir for CMV infection. NOTE: A participant who is not continuing with the same anti-CMV drug(s) (ganciclovir, valganciclovir or foscarnet) for the study treatment (if randomized to the investigator assigned anti-CMV treatment arm), must discontinue their use before the first dose of study drug. If participant is currently being treated with cidofovir and is assigned another anti-CMV therapy by the investigator, the participant must discontinue its use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment. 3. Be receiving leflunomide, letermovir, or artesunate when study treatment is initiated. NOTE: Participants receiving leflunomide must discontinue the use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment. Participants receiving letermovir must discontinue use at least 3 days prior to the first dose of study treatment. Participants receiving artesunate must discontinue the use prior to the first dose of study treatment. 4. Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study treatment that would preclude administration of oral/enteral medication. 5. Have known hypersensitivity to the active substance or to an excipient for a study treatment. 6. Have tissue invasive CMV disease with central nervous system involvement including the retina (example, CMV retinitis). 7. Have serum aspartate aminotransferase (AST) > 5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase (ALT) > 5 times ULN at screening, or total bilirubin >= 3.0 x ULN at screening (except for documented Gilbert's syndrome), by local or central lab. Participants with biopsy confirmed CMV hepatitis will not be excluded from study participation despite AST or ALT > 5 times ULN at screening. 8. Have known positive results for human immunodeficiency virus (HIV). Participants must have a confirmed negative HIV test result within 3 months of study entry or, if unavailable, be tested by a local laboratory during the screening period. 9. Require mechanical ventilation or vasopressors for hemodynamic support at the time of enrollment. 10. Be female and pregnant or breast feeding. 11. Have previously received maribavir. 12. Have received any investigational agent with known anti-CMV activity within 30 days before initiation of study treatment or investigational CMV vaccine at any time. 13. Have received any unapproved agent or device within 30 days before initiation of study treatment. 14. Have active malignancy with the exception of nonmelanoma skin cancer. Participants who have had a hematopoietic stem cell transplant (HSCT) and who experience relapse or progression of the malignancy as per investigator's opinion are not to be enrolled. 15. Be undergoing treatment for acute or chronic hepatitis C. 16. Have any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with the interpretation of study results, contraindicate the administration of the assigned study treatment, or compromise the safety or well-being of the participant.
Drug: Maribavir, Drug: Ganciclovir, Drug: Valganciclovir, Drug: Foscarnet, Drug: Cidofovir
Cytomegalovirus (CMV)
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A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection

The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.
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studyfinder@utsouthwestern.edu
Mamta Jain
41138
All
13 Years to 85 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03376321
STU-2018-0019
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Inclusion Criteria:

• Tested positive for influenza A infection after the onset of symptoms using a polymerase chain reaction (PCR)-based or other rapid molecular diagnostic assay
• Requires hospitalization to treat influenza infection and/or to treat complications of influenza infection (for example, radiological signs of lower respiratory tract disease, septic shock, central nervous system [CNS] involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney disease, severe dehydration, myocarditis, pericarditis, ischemic heart disease, exacerbation of underlying chronic pulmonary disease, including asthma, chronic obstructive pulmonary disease [COPD], decompensation of previously controlled diabetes mellitus), including participants admitted to the Intensive Care Unit (ICU)
• Enrollment and initiation of study drug treatment less than or equal to (<=)96 hours after onset of influenza symptoms
• Being on invasive mechanical ventilation or having a peripheral capillary oxygen saturation (SpO2) less than (<)94 percent (%) on room air during screening. Participants with known pre-influenza SpO2 <94% must have an SpO2 decline greater than or equal to (>=)3% from pre-influenza SpO2 during screening
• Having a screening/baseline National Early Warning Score 2 (NEWS2) of >=4
Exclusion Criteria:

• Received more than 3 doses of influenza antiviral medication (for example, oseltamivir [OST] or zanamivir), or any dose of ribavarin (RBV) within 2 weeks, prior to first study drug intake. Received intravenous (IV) peramivir more than one day prior to screening
• Unstable angina pectoris or myocardial infarction within 30 days prior to screening (inclusive)
• Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia, or risk factors for Torsade de Pointes syndrome
• Known severe hepatic impairment (Child Pugh C cirrhosis) or chronic hepatitis C infection undergoing hepatitis C antiviral therapy
• Severely immunocompromised in the opinion of the investigator (for example, known cluster of differentiation 4 plus [CD4+] count <200 cells per cubic millimeter [cells/mm^3], absolute neutrophil count <750/mm^3, first course of chemotherapy completed within 2 weeks prior to screening, history of stem cell transplant within 1 year prior to screening, any history of a lung transplant)
• Known allergies, hypersensitivity, or intolerance to pimodivir or its excipients
Drug: Pimodivir 600 mg, Drug: Placebo, Other: SOC Treatment
Influenza A
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A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia (COVASTIL)

This is a Phase II, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of MSTT1041A (astegolimab) compared with placebo and of UTTR1147A compared with placebo, in combination with standard of care (SOC), in patients hospitalized with severe coronavirus disease 2019 (COVID-19) pneumonia.
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studyfinder@utsouthwestern.edu
Raksha Jain
19733
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04386616
STU-2020-0461
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Inclusion Criteria:

• Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
• Peripheral capillary oxygen saturation (SpO2) ≤93% (on room air or supplemental oxygen) or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ≤300 millimetres of mercury (mmHg) or requiring supplemental oxygen to maintain SpO2 >93% or requirement for supplemental oxygen to maintain SpO2 at an acceptable level per local standard of care
Exclusion Criteria:

• Pregnant or breastfeeding, or positive pregnancy test at screening
• Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
• In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
• Participating in another clinical drug trial
• Treatment with investigational therapy (other than for COVID-19) within 5 half-lives or 30 days (whichever is longer) prior to initiation of study drug
• Use of Janus kinase (JAK) inhibitor within 30 days or 5 drug elimination half-lives (whichever is longer) prior to screening
• Have received high-dose systemic corticosteroids (≥1 mg/kg/day methylprednisolone or equivalent) within 72 hours prior to Day 1
• Known HIV infection with CD4 <200 cells/microlitre (uL) or <14% of all lymphocytes
• ALT or AST >10 times the upper limit of normal (ULN) detected at screening
• History of anaplastic large-cell lymphoma or mantle-cell lymphoma
• History of cancer within the previous 5 years unless it has been adequately treated and considered cured or remission-free in the investigator's judgment
• Clinical evidence of active or unstable cardiovascular disease (e.g., acute myocardial ischemia or decompensated heart failure), as determined by investigator assessment, ECG, laboratory assessment, or echocardiographic data
• History of moderate or severe allergic, anaphylactic, or anaphylactoid reactions or hypersensitivity to any component of study treatment
Drug: MSTT1041A, Drug: MSTT1041A-matched Placebo, Drug: UTTR1147A, Drug: UTTR1147A-matched Placebo
COVID-19 Pneumonia, Lung/Thoracic
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Anti-thrombotics for Adults Hospitalized With COVID-19 (ACTIV-4)

This is a randomized, open label, adaptive platform trial to compare the effectiveness of antithrombotic strategies for prevention of adverse outcomes in COVID-19 positive inpatients
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studyfinder@utsouthwestern.edu
Ambarish Pandey
125045
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT04505774
STU-2020-1018
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Inclusion Criteria:

• ≥ 18 years of age
• Hospitalized for COVID-19
• Enrolled within 72 hours of hospital admittance or 72 hours of positive COVID test
• Expected to require hospitalization for > 72 hours
Exclusion Criteria:

• Imminent death
• Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
• Pregnancy
Drug: theraputic heparin, Drug: prophylactic heparin
Cardiovascular, Covid19
anti-coagulation, antithrombosis, anticoagulation, ACTIV, inpatient, heparin
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Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)

The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.
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studyfinder@utsouthwestern.edu
Mamta Jain
41138
All
12 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04292899
STU-2020-0259
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Key
Inclusion Criteria:

• Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥18), or willing and able to provide assent (age ≥12 to <18, where locally and nationally approved) prior to performing study procedures
• Aged ≥ 18 years (at all sites), or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC))
• Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
• Currently hospitalized
• Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen at screening Key
Exclusion Criteria:

• Participation in any other clinical trial of an experimental treatment for COVID-19
• Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing
• Evidence of multiorgan failure
• Mechanically ventilated (including V-V ECMO) ≥ 5 days, or any duration of V-A ECMO.
• Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
• Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of age Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Drug: Remdesivir, Drug: Standard of Care
COVID-19, Lung/Thoracic
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Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting

The primary objectives of this study are to evaluate the efficacy of remdesivir (RDV) in reducing the rate of hospitalization or death in non-hospitalized participants with early stage coronavirus disease 2019 (COVID-19) and to evaluate the safety of RDV administered in an outpatient setting.
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studyfinder@utsouthwestern.edu
Muhammad Beg
125541
All
12 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04501952
STU-2020-0966
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Key
Inclusion Criteria:

• Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (individuals ≥ 18 years of age) or assent (individuals ≥ 12 and < 18 years of age) prior to performing study procedures. For individuals ≥ 12 and < 18 years of age, a parent or legal guardian must be willing and able to provide written informed consent prior to performing study procedures
• Either:
• Age ≥ 18 years (at all sites) or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC) with at least 1 pre-existing risk factor for progression to hospitalization (chronic lung disease, hypertension, cardiovascular or cerebrovascular disease, diabetes, obesity (body mass index ≥ 30), immunocompromised, chronic mild or moderate kidney disease, chronic liver disease, current cancer, or sickle cell disease)
• OR aged ≥ 60 years
• SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) ≤ 4 days prior to screening
• Presence of ≥ 1 symptom(s) consistent with COVID-19 for ≤ 7 days prior to randomization
• Oxygen saturation (SpO2) > 94% on room air
• Not currently requiring hospitalization Key
Exclusion Criteria:

• Participation in any other clinical trial of an experimental treatment and prevention for COVID-19
• Prior hospitalization for COVID-19
• Treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2
• Use of hydroxychloroquine or chloroquine ≤ 7 days prior to screening
• Requiring oxygen supplementation Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Drug: RDV, Drug: Placebo to Match RDV
COVID-19
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Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA

There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
David Sher
156059
All
18 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT02135042
STU 072014-041
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Inclusion Criteria:

• Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of cancer of the nasopharynx
• Patients must have detectable pretreatment plasma EBV DNA, determined by the central lab prior to Step 2 registration
• Stage II-IVB disease (American Joint Committee on Cancer [AJCC], 7th edition [ed.]) with no evidence of distant metastasis, based upon the following minimum diagnostic workup:
• History/physical examination by a Medical Oncologist or Clinical Oncologist or Radiation Oncologist or Ear, Nose, Throat specialist (ENT), which must include an endoscopic evaluation, a complete list of current medications, and assessment of weight and weight loss in the past 6 months within 21 days prior to registration
• Evaluation of tumor extent with magnetic resonance imaging (MRI) of the nasopharynx and neck within 28 days prior to registration; if MRI is medically contraindicated, obtain computed tomography (CT) scan with =< 3 mm contiguous slices with contrast and bone windows (to evaluate base of skull involvement); Note: If a treatment planning CT scan is used, it must be with =< 3 mm contiguous slices with contrast and be read by a radiologist
• To rule out distant metastasis, patients must undergo the following imaging within 28 days prior to registration:
• A CT scan with contrast of the chest, abdomen, and/or pelvis or a total body positron emission tomography (PET)/CT scan (non-contrast PET/CT is acceptable)
• A bone scan only when there is suspicion of bone metastases (a PET/CT scan can substitute for the bone scan)
• Zubrod performance status 0-1 within 21 days prior to registration
• Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
• Platelets >= 100,000 cells/mm^3
• Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 1.5 x institutional ULN
• Alkaline phosphatase =< 1.5 x institutional ULN
• Serum creatinine =< 1.5 mg/dl or calculated creatinine clearance (CC) >= 50 ml/min determined by 24-hour urine collection or estimated by Cockcroft-Gault formula
• Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
• Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control throughout protocol treatment
• Patient must provide study specific informed consent prior to study entry, including the mandatory pre-treatment plasma EBV DNA assay
Exclusion Criteria:

• Prior invasive malignancy (except node negative, non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; however, at least 6-weeks recovery is necessary if the last regimen included nitrosourea or mitomycin
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss that is tumor-related is allowed
• >= Grade 2 peripheral sensory neuropathy (CTCAE, v. 4.0)
• Severe, active co-morbidity, defined as follows:
• Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy
• Unstable angina and/or uncontrolled congestive heart failure within the past 6 months
• Myocardial infarction within the last 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; note that patients switched from IV antibiotics and currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
• Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
• Prior allergic reaction to the study drug(s) involved in this protocol
• Patients with undetectable pre-treatment plasma EBV DNA
Drug: Cisplatin, Other: Clinical Observation, Drug: Fluorouracil, Drug: Gemcitabine Hydrochloride, Radiation: Intensity-Modulated Radiation Therapy, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Quality-of-Life Assessment
Epstein-Barr Virus Infection, Stage II Nasopharyngeal Carcinoma, Stage III Nasopharyngeal Carcinoma, Stage IVA Nasopharyngeal Carcinoma, Stage IVB Nasopharyngeal Carcinoma, Head and Neck
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STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention

Aim 1: The investigators will conduct a randomized controlled trial comparing two strategies to promote HCV screening, follow-up testing, and treatment among baby-boomers (i.e. persons born between 1945-1965): inreach with electronic medical record alerts and provider education vs. combination of inreach and provider education plus mailed outreach and patient navigation. Aim 2: The investigators will evaluate patient navigation strategies to promote follow-up testing and treatment evaluation among non-baby boomer Parkland patients (i.e. born before 1945 or after 1965) who are either: a) HCV antibody positive but have not completed follow-up viral load testing or b) HCV viral load positive and who have not completed in-clinic treatment evaluation.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Amit Singal
117533
All
53 Years to 74 Years old
N/A
This study is also accepting healthy volunteers
NCT03706742
STU 072015-022
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Inclusion Criteria:

• born between 1945 and 1965
• ≥ 1 outpatient visit during 12 months prior to randomization at Parkland
• no prior HCV screening (prior HCV antibody, viral load, or genotype).
• any active medical coverage
• speaks Spanish or English
Exclusion Criteria:

• a life expectancy less than one year including end stage CHF, end stage COPD, metastatic cancer, and those who received a palliative care or hospice referral in the past year
• history of HCC.
• non-English or Spanish speakers
• no address or phone number on file
Behavioral: Mailed outreach
Hepatitis C, Hepatocellular Carcinoma, Liver
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A Study of AeroVanc for the Treatment of MRSA Infection in CF Patients

This study is a multi-center, randomized phase III study to evaluate the clinical effectiveness of AeroVanc in persistent MRSA in patients with Cystic Fibrosis.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Preeti Sharma
117060
All
6 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03181932
STU 092016-033
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Inclusion Criteria 1. Subjects ≥ 6 years of age at time of Informed Consent Form (ICF) or Assent Form signing. 2. Confirmed diagnosis of CF, determined by having clinical features consistent with the CF phenotype, plus one of the following: 1. Positive sweat chloride test (value ≥ 60 mEq/L), 2. Genotype with 2 mutations consistent with CF (i.e., a mutation in each of the cystic fibrosis transmembrane conductance regulator [CFTR] genes). 3. Positive sputum culture or a throat swab culture for MRSA at Screening. 4. In addition to the Screening sample, have at least 2 prior sputum or throat swab cultures positive for MRSA, of which at least 1 sample is more than 6 months prior to Screening. At least 50% of all MRSA cultures (sputum or throat swab culture) collected from the time of the first positive culture (in the previous 1 year) must have tested positive for MRSA. (Note: Screening sample may count towards 50% positive count) 5. Forced expiratory volume in 1 second (FEV1) ≥ 30% and ≤ 90% of predicted that is normal for age, gender, race, and height, using the Global Lung Function Initiative (GLI) equation. 6. At least 1 episode of acute pulmonary infection treated with non-maintenance antibiotics within 12 months prior to the Baseline visit. (Initiation of treatment with intermittent inhaled anti-Pseudomonal therapy will not qualify as treatment with non-maintenance antibiotics). 7. If female of childbearing potential, an acceptable method of contraception must be used during the study and must be combined with a negative pregnancy test obtained during Screening; sexually active male subjects of reproductive potential who are non-sterile (i.e., male who has not been sterilized by vasectomy for at least 6 months, and were not diagnosed with infertility through demonstration of azoospermia in a semen sample and/or absence of vas deferens through ultrasound) must be willing to use a barrier method of contraception, or their female partner must use an acceptable method of contraception, during the study. For purposes of this study, the Sponsor defines "acceptable methods of contraception" as: 1. Oral birth control pills administered for at least 1 monthly cycle prior to administration of the study drug. 2. A synthetic progestin implanted rod (eg, Implanon®) for at least 1 monthly cycle prior to the study drug administration but not beyond the 4th successive year following insertion. 3. Intrauterine devices (IUDs), inserted by a qualified clinician for at least 1 monthly cycle prior to study drug administration. 4. Medroxyprogesterone acetate (eg, Depo-Provera®) administered for a minimum of 1 monthly cycle prior to administration of the study drug and continuing through 1 month following study completion. 5. Hysterectomy or surgical sterilization. 6. Abstinence. 7. Double barrier method (diaphragm with spermicidal gel or condoms with contraceptive foam). NOTE: For subjects prescribed Orkambi: Orkambi may substantially decrease hormonal contraceptive exposure, reducing the effectiveness and increasing the incidence of menstruation-associated adverse reactions. Hormonal contraceptives, including oral, injectable, transdermal, and implantable, should not be relied upon as an effective method of contraception when co-administered with Orkambi. 8. Able and willing to comply with the protocol, including availability for all scheduled study visits and able to perform all techniques necessary to use the AeroVanc inhaler and measure lung function. 9. Agree not to smoke during any part of the clinical trial (Screening visit through end of study). 10. Subjects with a P. aeruginosa co-infection must either be stable on a regular suppression regimen of inhaled antibiotics or must be, in the opinion of the Investigator, stable despite the lack of such treatment. Exclusion Criteria 1. Use of anti-MRSA treatments prescribed as maintenance therapy (intravenous [IV] or inhaled treatment within 28 days; oral treatment within 14 days) prior to the Baseline visit. 2. Use of non-maintenance antibiotic for pulmonary infection or extrapulmonary MRSA infection (IV or inhaled antibiotic within 28 days; oral antibiotic within 14 days) prior to the Baseline visit. 3. History of previous allergies or sensitivity to vancomycin, or other component(s) of the study drug or placebo except for a history of red-man syndrome. 4. Inability to tolerate inhaled products. 5. First time sputum culture or throat swab culture yielding B. cepacia, or nontuberculous Mycobacteria in the previous 6 months to Screening. 6. History of lung or other solid organ transplantation or currently on the list to receive lung or other solid organ transplantation. 7. Resistance to vancomycin at Screening (vancomycin resistant Staphylococcus aureus [VRSA], or vancomycin intermediate resistant Staphylococcus aureus [VISA], with minimum inhibitory concentration [MIC] ≥ 8 μg/mL). 8. Oral corticosteroids in doses exceeding 10 mg prednisone per day or 20 mg prednisone every other day, or equipotent doses of other corticosteroids. 9. Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid medications within 14 days, or changes in CFTR modulators within 28 days, prior to the Baseline visit. 10. Abnormal laboratory findings or other findings or medical history at Screening that, in the Investigator's opinion, would compromise the safety of the subject or the quality of the study data. 11. Inability to tolerate inhalation of a short acting beta2 agonist 12. SpO2 <90% at Screening. 13. Changes in physiotherapy technique or physiotherapy scheduled within 1 week of the Baseline visit. 14. Administration of any investigational drug or device within 4 weeks prior to the Screening visit and during the study 15. Female with positive pregnancy test result during Screening, pregnant (or intends to become pregnant), lactating or intends to breastfeed during the study. 16. Renal insufficiency, defined as creatinine clearance < 50 mL/min using the Cockcroft-Gault equation for adults or Schwartz equation for children at the Screening visit. 17. Abnormal liver function, defined as ≥ 4x upper limit of normal (ULN), of serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT), or known cirrhosis at Screening. 18. Diagnosed with clinically significant hearing loss. 19. History of positive result for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). 20. Planned hospitalizations for prophylaxis antibiotic treatment within 28 days prior to Baseline visit or during the double-blind period (Period 1).
Drug: Vancomycin inhalation powder, Drug: Placebo inhalation powder
Cystic Fibrosis, MRSA, Lung/Thoracic
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Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation (ACES)

The purpose of this study is to evaluate whether virus-specific T cell lines (VSTs) are safe and can effectively control three viruses (EBV, CMV, and adenovirus) in patients who have had a stem cell transplant and also in patients that have a primary immunodeficiency disorder with no prior stem cell transplant.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Victor Aquino
10208
All
Not specified
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03475212
STU 052018-016
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Inclusion Criteria Patients who have received any type of allogeneic transplant or who have a primary immunodeficiency disorder will be eligible if they have CMV, adenovirus, and/or EBV infection/disease with failure of treatment after 7 days of standard therapy OR if unable to tolerate standard therapy.
• Patients must meet one of the following criteria:
• Recipient of prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cell or single or double cord blood within the previous 18 months, OR
• Have a diagnosed primary immunodeficiency disorder (as defined by clinical and laboratory evaluations) and not undergone HSCT.
• Treatment of the following persistent or relapsed infections despite standard therapy:
• CMV: Treatment of persistent or relapsed CMV disease or infection after standard therapy. For CMV infection, standard therapy is defined as antiviral therapy with ganciclovir, foscarnet or cidofovir for at least 14 days.
• Adenovirus: Treatment of persistent or relapsed adenovirus infection or disease despite standard therapy. Standard therapy is defined as antiviral therapy with cidofovir or brincidofovir.
• EBV: Treatment of persistent or relapsed EBV infection despite standard therapy. For EBV infection, standard therapy is defined as rituximab given at 375 mg/m2 in patients for 1-4 doses with a CD20+ tumor. Additional
Inclusion Criteria:

• Patients with simultaneous infections with CMV, EBV and/or Adenovirus infections are eligible if one or more infection(s) is persistent or relapsed despite standard therapy as defined above. Patients with multiple infections with one or more reactivation and one or more controlled infection are eligible to enroll.
• Clinical status at enrollment that allows tapering of steroids to equal or less than 0.5 mg/kg/day prednisone (or equivalent) prior to infusion of the VST doses.
• Negative pregnancy test in female patients if applicable (childbearing potential who have received a reduced intensity conditioning regimen).
• Written informed consent and/or signed assent line from patient, parent or guardian. Exclusion Criteria
• Patients receiving ATG, Campath, Basiliximab or other immunosuppressive monoclonal antibodies targeting T-cells within 28 days of screening for enrollment.
• Patients who have received donor lymphocyte infusion (DLI) or other experimental cellular therapies within 28 days.
• Current therapy with ruxolitinib or other JAK inhibitors within the previous 3 days.
• Patients with other uncontrolled infections, defined as bacterial or fungal infections with clinical signs of worsening despite standard therapy. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.
• Progressing infection is defined as hemodynamic instability, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
• Patients with active and uncontrolled relapse of malignancy (if applicable).
Biological: Virus Specific T-cell (VST) infusion
Lymphoma, Multiple Myeloma, Cytomegalovirus Infections, Adenovirus Infection, EBV Infection, Other, Leukemia, Other, Leukemia, Not Otherwise Specified, Lymphoid Leukemia, Myeloid and Monocytic Leukemia, Other Hematopoietic
Hematopoietic Stem Cell Transplant, Primary Immune Deficiency Disease
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Translating the ABCS Into HIV Care (ABCSinHIV)

The overall objective of this project is to develop and rigorously test implementation strategies to address the gap in scientific knowledge of lower use of evidence-based interventions commonly referred to as the ABCS (aspirin, blood pressure control, cholesterol control, and smoking cessation)which contributes to the growing CVD morbidity and mortality among PLH.
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studyfinder@utsouthwestern.edu
Amneris Luque
167338
All
40 Years to 79 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03902431
STU-2019-1381
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Inclusion Criteria:
Sites:
• Serve a cohort of at least 100 HIV patients
• Have an Electronic Health Record (EHR)
• Agree to collaborate on implementing feasible adaptations of intervention strategies Patients:
• Patient of the site with a diagnosis of HIV
• Age 40-79 years
• ≥5% risk for CVD as calculated using the ASCVD Risk Estimator Plus
• Willing to participate
• No plans to leave the site in the next 12 months
• Proficient in either English or Spanish
• Own a cell phone with texting capabilities Clinicians:
• Physicians, Physicians Assistants, or Nurse Practitioners who provide direct HIV care to patients
• Work at a participating site
• Willing to implement the project's intervention strategies
Exclusion Criteria:
Patients:
• Currently participating in another CVD trial
• Have experienced a prior cardiac or vascular event such as myocardial infarction (MI) or cerebrovascular accident (CVA)
• Have had a CVD procedure such as installation of a stent or angioplasty
• Have peripheral vascular disease, intermittent claudication or peripheral arterial disease
• Are pregnant
• Lacks capacity to consent Clinicians: • Planning to leave the site within the next 12 months
Behavioral: ABCS training
HIV, Cardiovascular Risk Factor, Cardiovascular
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Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter Randomized, Controlled Trial (VANCO) (VANCO)

The Vancomycin Study is a multi-center, prospective randomized controlled trial that will compare the proportion of deep surgical site infections within 6 months in patients treated with local Vancomycin powder compared to those treated without local Vancomycin powder at the time of fracture fixation.
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Drew Sanders
104040
All
18 Years to 80 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02227446
STU 122014-037
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Inclusion Criteria:

• All "high energy" tibial plateau fractures treated operatively with plate and screw fixation.
• We define "high energy" tibial plateau fractures as patients who are either:
• Initially treated with an external fixation (with or without limited internal fixation) and treated definitively more than 3 days later after swelling has resolved.
• Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment.
• Any tibial plateau fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds.
• All "high energy" pilon (distal tibial plafond) fractures treated operatively with plate and screw fixation. We define "high energy" pilon fractures as patients who are either:
• Initially treated with an external fixation (with or without fibula fixation or limited internal fixation) and treated definitively more than 3 days later after swelling has resolved.
• Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment.
• Any tibial pilon fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds.
• Ages 18 to 80 years
• Patients may have co-existing non-tibial infection, with or without antibiotic treatment.
• Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
• Patients may have a head injury
• Patients may have a portion of the fixation (e.g. fibula fixation in pilon or percutaneous screws across a tibial plateau fracture) prior to definitive plate fixation, at the initial surgery before randomization.
• Patients may have other orthopedic and non-orthopaedic injuries.
• Patients may have pre-existing musculoskeletal injuries, be non ambulators, or have spinal cord injuries.
• Women and minorities are included
Exclusion Criteria:

• The study injury: tibial plateau, pilon, is already infected at time of study enrollment.
• Patient speaks neither English nor Spanish.
• Patients who have already had definitive fixation prior to enrollment in the study.
• Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury or those how are intellectually challenged without adequate family support).
• Patients with allergies, drug administration reactions, or other sensitivities to Vancomycin (such as a history of Redman's Syndrome).
• Pregnancy.
• The study injury is a type IIIB or IIIC open fracture.
Drug: Vancomycin antibiotic powder
Post Operative Surgical Site Infection, Bones and Joints
Surgical site infection risk prevention, Bacterial species type and antibacterial sensitives
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Rituximab and LMP-Specific T-Cells in Treating Pediatric Solid Organ Recipients With EBV-Positive, CD20-Positive Post-Transplant Lymphoproliferative Disorder

This pilot phase II trial studies how well rituximab and latent membrane protein (LMP)-specific T-cells work in treating pediatric solid organ recipients with Epstein-Barr virus-positive, cluster of differentiation (CD)20-positive post-transplant lymphoproliferative disorder. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. LMP-specific T-cells are special immune system cells trained to recognize proteins found on post-transplant lymphoproliferative disorder tumor cells if they are infected with Epstein-Barr virus. Giving rituximab and LMP-specific T-cells may work better in treating pediatric organ recipients with post-transplant lymphoproliferative disorder than rituximab alone.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Tamra Slone
67555
All
up to 29 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02900976
STU 032017-108
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Inclusion Criteria:

• Patient must have a history of solid organ transplantation
• Patients must have biopsy-proven newly diagnosed, relapsed or refractory polymorphic or monomorphic PTLD using the World Health Organization (WHO) classification and that is:
• CD20 positive
• EBV positive by Epstein-Barr virus early ribonucleic acid (RNA) (EBER) in situ hybridization (preferred) and/or LMP immunoperoxidase staining
• There must be evaluable disease at study entry either by imaging or by serial endoscopic biopsies.
• Note: a measurable node must have an LDi (longest diameter) greater than 1.5 cm; a measurable extranodal lesion should have an LDi greater than 1.0 cm; all tumor measurements must be recorded in millimeters (or decimal fractions of centimeters)
• Patients must be considered medically refractory to decreased immunosuppression (50% or greater reduction) for at least 1 week or there must be documentation in the medical chart that decreased immunosuppression would be associated with an unacceptable risk of rejection
• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0 or 1
• Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
• Patients must have a life expectancy of >= 8 weeks
• Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
• Myelosuppressive chemotherapy: must not have received within 2 weeks of entry onto this study
• COHORT A and B: Patient must not have received therapy with anti-CD20 monoclonal antibodies within 90 days of entry onto this study
• COHORT C: Patient must have received rituximab at 375 mg/m^2 weekly for at least 3 doses within the last 90 days prior to study enrollment
• Must not have received any prior radiation to any sites of measurable disease
• Must not have received any prior stem cell transplant
• Must not have received investigational therapy within 30 days of entry onto this study
• Must not have received prior EBV or LMP-specific T cells within 90 days of entry onto this study
• Must not have received alemtuzumab or other anti-T-cell antibody therapy within 28 days of entry onto this study
• COHORT C: HLA typing is available and will be submitted at the time of enrollment.
Exclusion Criteria:

• Burkitt morphology
• Central nervous system (CNS) involvement; CNS status must be confirmed by lumbar puncture
• Note: lumbar puncture can be performed at the time of diagnosis and does not need to be repeated unless there is a change in neurological status or it was performed more than 14 days prior to study entry
• Bone marrow involvement (> 25%)
• Note: bone marrow aspiration/biopsy can be performed at the time of diagnosis and does not need to be repeated unless there is a change in peripheral blood counts or it was performed more than 14 days prior to study entry
• Fulminant PTLD defined as: fever > 38 degrees Celsius (C), hypotension, and evidence of multi-organ involvement/failure including two or more of the following:
• Bone marrow (including pancytopenia without any detectable B-cell proliferation)
• Liver (coagulopathy, transaminitis and/or hyperbilirubinemia)
• Lungs (interstitial pneumonitis with or without pleural effusions)
• Gastrointestinal hemorrhage
• Any documented donor-derived PTLD
• Hepatitis B or C serologies consistent with past or current infections because of the risk of reactivation with rituximab
• Severe and/or symptomatic refractory concurrent infection other than EBV
• Pregnant females are ineligible since there is no available information regarding human fetal or teratogenic toxicities
• Lactating females are not eligible unless they have agreed not to breastfeed their infants
• Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
• Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and for 12 months following completion of study therapy.
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Biological: Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes, Biological: Rituximab
EBV-Related Post-Transplant Lymphoproliferative Disorder, Monomorphic Post-Transplant Lymphoproliferative Disorder, Polymorphic Post-Transplant Lymphoproliferative Disorder, Recurrent Monomorphic Post-Transplant Lymphoproliferative Disorder, Recurrent Polymorphic Post-Transplant Lymphoproliferative Disorder, Refractory Monomorphic Post-Transplant Lymphoproliferative Disorder, Refractory Polymorphic Post-Transplant Lymphoproliferative Disorder
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Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)

The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to <18 years of age (adolescents); Age Group 2: From 2 to <12 years of age (children); and Age Group 3: From birth to <2 years of age (neonates, infants and toddlers). All participants will receive open label LET for 14 weeks (~100 days) post-transplant, with doses based on body weight and age.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Paul Sue
157043
All
up to 17 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03940586
STU-2018-0279
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Inclusion Criteria:

• All participants 12 to <18 years old must have documented positive CMV serostatus (CMV IgG seropositive) for the recipient (R+). Participants from birth to <12 years old must have documented positive CMV serostatus (CMV IgG seropositive) for the recipient (R+) and/or the donor (D+) and the time of screening.
• Is the recipient of a first allogeneic HSCT (bone marrow, peripheral blood stem cell, or cord blood transplant).
• Has undetectable CMV DNA from a plasma or whole blood sample collected within 5 days prior to enrollment.
• Is within 28 days post-HSCT at the time of enrollment.
• Females are not pregnant, not breastfeeding,and is not a woman of childbearing potential (WOCBP); or is a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 28 days after the last dose of study intervention.
• Participants from 2 to <18 years of age must not be on concomitant Cyclosporin A (CsA), and must be able to take LET tablets or the oral granules (either by mouth or via G tube/NG tube), provided the participant does not have a condition that may interfere with the absorption of oral medication (e.g. vomiting, diarrhea, or a malabsorptive condition) from the day of enrollment until the intensive PK sampling is completed in these participants
Exclusion Criteria:

• Has received a previous allogeneic HSCT (Note: receipt of a previous autologous HSCT is acceptable).
• Has a history of CMV end-organ disease within 6 months prior to enrollment.
• Has evidence of CMV viremia at any time from either signing of the ICF or the HSCT procedure, whichever is earlier, until the time of enrollment.
• Has suspected or known hypersensitivity to active or inactive ingredients of LET formulations.
• Has severe hepatic insufficiency within 5 days prior to enrollment.
• Is on hemodialysis or has end-stage renal impairment.
• Has both moderate hepatic insufficiency and moderate-to-severe renal insufficiency.
• Has an uncontrolled infection on the day of enrollment.
• Requires mechanical ventilation or is hemodynamically unstable at the time of enrollment.
• Has a documented positive result for a human immunodeficiency virus antibody (HIVAb) test at any time prior to enrollment, or for hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollment.
• Has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (e.g. lymphomas).
• Has a preexisting cardiac condition a) for which the patient is currently being treated or b) which required hospitalization within the last 6 months or c) that may be expected to recur during the course of the trial.
• Has received within 7 days prior to screening any of the following: ganciclovir; valganciclovir; foscarnet; acyclovir; valacyclovir; famciclovir.
• Has received within 30 days prior to screening of any of the following: cidofovir; CMV immunoglobulin; any investigational CMV antiviral agent/biologic therapy; Rifampin and other strong inducers (such as phenytoin, carbamazepine, St John's wort (Hypericum perforatum), rifabutin and phenobarbital) and moderate inducers such as nafcillin, thioridazine, modafinil and bosentan.
• Has received LET at any time prior to enrollment in this study.
• Is currently participating or has participated in a study with an unapproved investigational compound or device within 28 days, or 5X half-life of the investigational compound (excluding monoclonal antibodies), whichever is longer, of initial dosing in this study.
• Has previously participated in this study or any other study involving LET.
• Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.
• Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through 28 days after the last dose of study intervention.
• Is expecting to donate eggs starting from the time of consent through 28 days after the last dose of study intervention.
• Has clinically relevant drug or alcohol abuse within 12 months of screening that may interfere with participant treatment, assessment, or compliance with the protocol, as assessed by the investigator.
Drug: Letermovir oral granules, Drug: Letermovir tablet, Drug: Letermovir intravenous
Cytomegalovirus (CMV) Infection
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Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

The primary objectives of the study by study part are: Part A: To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures, and to inform/confirm the final sample size determination for Part B. Part B: To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures. Part C: To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures. The secondary objectives of the study are: - To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 52 weeks in adult and adolescent patients with EoE - To explore the relationship between dupilumab concentration and responses in adult and adolescent patients with EoE, using descriptive analyses
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Christopher Parrish
168280
All
12 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03633617
STU-2019-0556
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Key Inclusion Criteria (Parts A & B):
• A documented diagnosis of EoE by endoscopic biopsy
• Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration
• History (by patient report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening Key Exclusion Criteria (Parts A & B):
• Body weight ≤40 kg
• Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab
• Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening.
• Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
• Active Helicobacter pylori infection
• History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery
• Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening
• History of bleeding disorders or esophageal varices
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study Key Exclusion Criteria (Part C):
• Participants who, during Part A or Part B, developed a serious adverse event (SAE) and/or adverse event (AE) deemed related to study drug, which in the opinion of the investigator could indicate that continued treatment with study drug may present an unreasonable risk for the participant
• Participants who became pregnant during Part A or Part B
• Participants who are prematurely discontinued from study drug due to an AE (patients who are prematurely discontinued from study drug due to lack of efficacy are eligible to enter Part C)
• Patients who did not undergo endoscopy with biopsies prior to receiving rescue treatment Note: Other inclusion/ exclusion criteria apply
Drug: Dupilumab, Drug: Placebo
Eosinophilic Esophagitis, Other
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A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients

HB-101 is a bivalent recombinant vaccine against human CMV infection. This is a randomized, placebo-controlled, phase 2 study to assess the safety, reactogenicity, immunogenicity, and efficacy of HB-101 in CMV-Seronegative patients receiving a kidney transplant from a CMV-Seropositive living donor and CMV-Seropositive patients.Patients enrolled should have a living donor kidney transplantation ideally planned between two to four months after the first injection of study drug (HB-101 or placebo).
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David Wojciechowski
188709
All
18 Years to 99 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03629080
STU-2019-1252
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Inclusion Criteria:
Patients who meet all of the following inclusion criteria will be eligible to participate in the study: 1. Male or female patients 18 years of age or older. 2. Patients must be eligible to undergo kidney transplantation from a living donor as per institutional standards. 3. For Groups 1 and 2 only: Patients must be CMV immunoglobulin G (IgG) seronegative (-) and receiving kidney for transplantation from donors who are CMV IgG seropositive (+). 4. For Group 3 only: Patients must be CMV immunoglobulin G (IgG) seropositive (+) and receiving kidney for transplantation from donors who are either CMV IgG seronegative (-) or seropositive (+). 5. Patients who would comply with the requirements of this protocol (e.g., return for follow up visits), as judged by the investigator.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study: 1. Patients planning to undergo multi-organ transplantation. 2. Patients participating in another interventional clinical study. 3. Previous vaccination with an investigational CMV vaccine. 4. Any confirmed or suspected immunodeficiency disorder (based on medical history and physical examination) that could interfere with the immune response or that presents a risk for the patient to receive a vaccine candidate in development. 5. Treatment with any chronic immunosuppressive medication or other immuno modifying drugs within 6 months prior to study entry. However, inhaled and topical steroids and low-dose oral corticosteroids (<10 milligrams a day of prednisone or equivalent) are allowed. 6. Prior history of CMV disease or CMV infection requiring anti-viral therapy 7. Patients with a rash, dermatological condition, or tattoo in the area of the injection site(s) that could interfere with administration site reaction rating. (Note: The injection site(s) can be the non-dominant arm [most preferred injection site], dominant arm, or either thigh [least preferred injection site], as judged by the investigator). 8. It is anticipated that the patient will be unavailable to complete the study follow-up.
Biological: HB-101 vaccine, Biological: placebo
Kidney Transplantation, Cytomegalovirus (CMV) Infection
solid organ transplantation, vaccine
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Cardiovascular Implications of COVID-19

At the end of December of 2019, a series of patients in Wuhan, China were struck with a mysterious respiratory infection. These isolated events have rapidly grown into a deadly, global pandemic. This pandemic is caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), which results in the Coronavirus Disease 2019 (COVID-19). For individuals infected with COVID-19, approximately 30% of the hospitalized cases are associated with cardiovascular complications. Data are emerging that individuals with pre-exiting conditions (like hypertension, diabetes, cancer, or medical issues related to the immune system) are most susceptible to complications related to COVID-19. Furthermore, individuals of certain racial and ethnic backgrounds (e.g. African American and Hispanic) are at a higher risk of death from COVID-19. Despite these emerging observations, it remains unclear who will develop the cardiovascular complications (acute myocardial injury with evidence of a myocarditis-like picture and cardiogenic shock) and what the long term sequelae of this disease will be for survivors of this infection after hospitalization. Thus, the goals of this project are to better understand the epidemiology of cardiac injury in acutely ill COVID-19 patients through deep cardiac phenotyping and identify the molecular profile of individuals most susceptible to cardiac injury from COVID-19.
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Justin Grodin
74652
All
18 Years to 80 Years old
This study is NOT accepting healthy volunteers
NCT04435457
STU-2020-0359
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Inclusion Criteria:

• Men and non-pregnant women 18-80 years old who were previously hospitalized with confirmed COVID-19
• Were alive at the time of discharge from COVID-19 hospitalization
• Had measured hs-cTnT levels during hospitalization
Exclusion Criteria:

• Prior cardiovascular disease (before COVID-19 infection), defined as self-reported history or electronic medical record diagnosis of cardiac arrest, myocardial infarction, coronary revascularization, heart failure, or stroke prior to COVID-19 hospitalization
• Urgent-coronary revascularization or type I myocardial infarction within the preceding 30 days
• Cardiac transplantation
• Body weight >250 lbs
• Moderate to severe chronic renal dysfunction defined by an eGFR ≤30 mL/min/1.73 m2
• Inability to safely undergo a CMR
• Unwilling or unable to provide informed consent
COVID-19, SARS-CoV 2, SARS Pneumonia, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere, Cardiac Complication
SARS-CoV 2, Troponin, Cardiac injury, COVID-19
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Inpatient Treatment With Anti-Coronavirus Immunoglobulin (ITAC)

This protocol will serve as a platform for assessing treatments for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Trials will involve sites around the world strategically chosen to ensure rapid enrollment. This trial will compare hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to standard of care (SOC), for preventing further disease progression and mortality related to COVID-19. SOC will include remdesivir unless it is contraindicated for an individual patient.
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studyfinder@utsouthwestern.edu
Mamta Jain
41138
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04546581
STU-2020-1025
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Inclusion Criteria:

• SARS-CoV-2 infection documented by PCR or other nucleic acid test (NAT) within 3 days prior to randomization OR documented by NAT more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection
• Symptomatic COVID-19 disease
• Duration of symptoms attributable to COVID-19 ≤ 12 days
• Requiring inpatient hospital medical care for clinical manifestations of COVID-19 (admission for public health or quarantine only is not included)
• Willingness to abstain from participation in other COVID-19 treatment trials until after study Day 7
• Provision of informed consent by participant or legally authorized representative
Exclusion Criteria:

• Prior receipt of SARS-CoV-2 hIVIG or convalescent plasma from a person who recovered from COVID-19 at any time
• Prior receipt of standard IVIG (not hyperimmune to SARS-CoV-2) within 45 days
• Current or predicted imminent (within 24 hours) requirement for any of the following: 1. Invasive ventilation 2. Non-invasive ventilation 3. Extracorporeal membrane oxygenation 4. Mechanical circulatory support 5. Continuous vasopressor therapy
• History of allergy to IVIG or plasma products
• History of selective IgA deficiency with documented presence of anti-IgA antibodies
• Any medical conditions for which receipt of the required volume of intravenous fluid may be dangerous to the patient (includes New York Association Class III or IV stage heart failure)
• Any of the following thrombotic or procoagulant disorders: 1. Acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous thrombosis within 28 days of randomization 2. History of prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antithrombin III deficiency, protein C deficiency, protein S deficiency or antiphospholipid syndrome
• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments
Drug: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG), Other: Placebo, Drug: Remdesivir
COVID-19, SARS-CoV-2, COVID, SARS (Severe Acute Respiratory Syndrome)
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An Observational Study of Hepatitis C Virus in Pregnancy (HCV)

This multi-center observational study examines risk factors for HCV transmission from mother to baby.
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Catherine Spong
179308
Female
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT01959321
STU 102012-033
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Inclusion Criteria:
1. Singleton pregnancy 2. An HCV antibody positive screen (case) measured using two FDA-approved ELISA tests, the Abbott Architect version 3.0 system and the Ortho HCV 3.0. 3. Gestational age at screening no later than 23 weeks and 6 days, and gestational age at enrollment no later than 27 weeks and 6 days, based on clinical information and evaluation of the earliest ultrasound as described below.
Exclusion Criteria:
1. Planned termination of pregnancy 2. Known major fetal anomalies or demise 3. Intention of the patient or the managing obstetricians for the delivery to be outside a MFMU Network center, unless special provisions are made to insure infant follow-up at two and 18 months of age. 4. Participation in this study in a previous pregnancy. 5. Unwilling or unable to commit to 18 months of follow-up for HCV positive infants
Hepatitis C
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Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection

The purpose of this study is to determine the safety and efficacy of treatment using a combination of drugs (entecavir and pegylated interferon) in children ages 3-<18 years old with immunotolerant chronic hepatitis B.
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Norberto Rodriguez-Baez
50856
All
3 Years to 18 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT01368497
STU 042011-031
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Inclusion Criteria:

• Enrolled in & completed the baseline evaluation in NCT01263600 OR completed necessary components of NCT01263600 baseline evaluation by the end of the baseline visit.
• 3 to <18 years at time of randomization (day 0).
• Documented chronic HBV infection as evidenced by detection of HBsAg in serum for ≥ 24 weeks prior to baseline OR positive HBsAg and negative anti-HBc IgM within 24 weeks of baseline visit.
• Presence of HBeAg in serum at the last screening visit within 6 weeks of baseline visit.
• Serum HBV DNA level >10^7 IU/mL on at least 2 occasions at least 12 weeks apart during the 52 weeks before baseline visit. The HBV DNA levels must be within 6 weeks of baseline visit.
• ALT ≤60 U/l in males or ≤40 U/l in females, measured on at least 2 occasions, at screening (within 6 weeks prior to baseline visit) & at least 12 weeks prior to the screening visit & within the 52 weeks prior to baseline visit.
• Compensated liver disease, with normal total bilirubin (except if Gilbert's syndrome), direct bilirubin ≤0.5 mg/dL, INR ≤1.5, and serum albumin ≥3.5 g/dL.
• Creatinine clearance 90 ml/min.
• Absence of hepatocellular carcinoma on liver ultrasound in the past 48 weeks. Exclusion criteria:
• Presence of infection with HCV-RNA or anti-HCV, anti-HDV, or HIV at screening.
• Presence of another cause of liver disease or HCC (serum alpha-fetoprotein >50ng /ml).
• Evidence of decompensated liver disease (Childs B-C).
• History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures).
• Females who are pregnant or breastfeeding.
• Adolescent females unwilling or unable to use an acceptable method of contraception if sexually active during the treatment period.
• Children currently breastfeeding while their mother is taking lamivudine, or those who were exposed to lamivudine for ≥24 weeks via maternal lamivudine treatment during pregnancy and/or while breastfeeding.
• Previous liver or other organ transplantation including engrafted bone marrow transplant.
• Hematological abnormalities during the screening period that contraindicate full dosing with study drugs, e.g absolute neutrophil count < 1.5 x 10^9 cells/L or platelet count < 120 x 10^9 cells/L.
• Known allergy to study drugs; peginterferon alfa-2a or entecavir.
• Treatment with systemic acyclovir or famciclovir within the previous 6 months.
• Need for ongoing use of any antivirals with activity against HBV during the course of the study or history of receiving treatment for HBV.
• Any use of illegal drugs OR use of alcoholic beverages which in the opinion of a study physician is sufficient to prevent adequate compliance with study procedures or increase the risk of pancreatitis or hepatotoxicity.
• History of immunologically mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis).
• History or other evidence of bleeding from esophageal varices or consistent with decompensated liver disease.
• History or other evidence of chronic pulmonary disease associated with functional limitation.
• History of significant cardiovascular diseases.
• History of a severe seizure disorder or current anticonvulsant use.
• History or other evidence of severe retinopathy.
• History of thyroid disease poorly controlled on prescribed medications. Participants with elevated thyroid stimulating hormone concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded.
• Concomitant use or use during ≤ 6 months prior to the first dose of study drug of anti-neoplastic, immunosuppressive, nephrotoxic or hepatotoxic medication, methadone, theophylline or medications that may affect renal excretion or hepatic metabolism are not permitted.
• Concomitant use of complementary or alternative medications purported to have antiviral activity.
• A participant may not be co-enrolled in another clinical trial where an investigational drug is administered.
• Any other condition or situation that in the opinion of a study physician would make the participant unsuitable for enrollment or could interfere with the participant participating in and completing the study.
Drug: Entecavir and peginterferon
Hepatitis B
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ACTIV-3: Therapeutics for Inpatients With COVID-19 (TICO)

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.
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Mamta Jain
41138
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04501978
STU-2020-0850
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Inclusion Criteria:

• Signed informed consent.
• Positive test for COVID-19 and progressive disease suggestive of ongoing COVID-19 infection.
• Symptoms of COVID-19 for ≤ 12 days.
• Require admission to hospital for acute medical care (not for purely public health or quarantine purposes).
Exclusion Criteria:

• Patients who have received plasma from a person who recovered from COVID-19 or who have received neutralizing monoclonal antibodies at any time prior to hospitalization.
• Patients not willing to abstain from participation in other COVID-19 treatment trials until after Day 5 of the study.
• Any condition which, in the opinion of the responsible investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.
• Patients considered unable to participate in study procedures.
• Women of child-bearing potential who are not already pregnant at study entry and who are unwilling to abstain from sexual intercourse with men, or practice appropriate contraception through Day 90 of the study.
• Men who are unwilling to abstain from sexual intercourse with women of child-bearing potential or who are unwilling to use barrier contraception through Day 90 of the study.
• [Stage 1 only] Presence at study enrollment of any of the following: 1. stroke 2. meningitis 3. encephalitis 4. myelitis 5. myocardial ischemia 6. myocarditis 7. pericarditis 8. symptomatic congestive heart failure 9. arterial or deep venous thrombosis or pulmonary embolism
• [Stage 1 only] Current or imminent requirement for any of the following: 1. invasive mechanical ventilation 2. ECMO (extracorporeal membrane oxygenation) 3. Mechanical circulatory support 4. vasopressor therapy 5. commencement of renal replacement therapy at this admission (i.e. not patients on chronic renal replacement therapy). Other investigational drug protocol-defined inclusion/exclusion criteria may apply.
Drug: LY3819253, Drug: Placebo, Drug: Remdesivir
Lung/Thoracic, Covid19
COVID-19, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-3, ACTIV3
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Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19)

This is a phase 3, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo tablets for 30 days.
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studyfinder@utsouthwestern.edu
Jessica Meisner
192342
All
40 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04322682
STU-2020-0773
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Inclusion Criteria:
1. Males and females, at least 40 years of age, capable and willing to provide informed consent; 2. Patient must have received a diagnosis of COVID-19 infection within the last 24 hours; 3. Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization); 4. Patient must possess at least one of the following high-risk criteria: 70 years or more of age, obesity (BMI ≥ 30 kg/m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥150 mm Hg), known respiratory disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, fever of ≥38.4°C within the last 48 hours, dyspnea at the time of presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count; 5. Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study and for 30 days after study completion; 6. Patient must be able and willing to comply with the requirements of this study protocol.
Exclusion Criteria:
1. Patient currently hospitalized or under immediate consideration for hospitalization; 2. Patient currently in shock or with hemodynamic instability; 3. Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption; 4. Patient with pre-existent progressive neuromuscular disease; 5. Estimated Glomerular filtration rate (eGFR), using the MDRD equation for all subjects being considered for enrollment, with a cut-off of < 30 mL/m in/1.73m2; 6. Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease; 7. Female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication; 8. Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout); 9. Patient with a history of an allergic reaction or significant sensitivity to colchicine; 10. Patient undergoing chemotherapy for cancer; 11. Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Drug: Colchicine, Drug: Placebo oral tablet
Corona Virus Infection
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PEDIATRIC SONICS: Pediatric Study of Neuropsychology and Imaging in CNS Demyelinating Syndromes. (SONICS)

Central Nervous System (CNS) demyelinating conditions include multiple sclerosis (MS), Acute Disseminated Encephalomyelitis (ADEM), Neuromyelitis Optica Spectrum Disorder (NMOSD) and Transverse Myelitis (TM). The symptoms of these conditions are quite variable from patient to patient, but can include motor, sensory, visual, gait and cognitive changes. Conventional MRI can be used to look for new anatomic changes, but fails to measure underlying biochemical changes in brain tissue. The purposes of this study are to identify the biologic and anatomic correlations between cognitive profiles and disease activity using MRI imaging techniques.
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Benjamin Greenberg
105091
All
12 Years to 18 Years old
This study is also accepting healthy volunteers
NCT03942952
STU-2019-0491
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Inclusion Criteria:
1. Diagnosis of Multiple Sclerosis , ADEM, anti-MOG antibody associated CNS demyelination 2. Age 12 to 18 inclusive at time of enrollment 3. Ability of parent or legal guardian to provide informed consent if participant is under 18. 4. Ability of patients age 12 and older to give assent 5. Completion of the signed HIPPA authorization form by a parent or legal guardian or by participants (18 years of age).
Exclusion Criteria:
1. Known history of traumatic brain injury that required medical care 2. Non-English speaking (based on standardized neuropsychological testing and questionnaires) 3. Claustrophobic, pregnant, the presence of metallic braces, implants or medical devices that are unsafe at 3T or 7T and/or interfere with the MRI/MRS signals
Neuromyelitis Optica, Transverse Myelitis, Acute Disseminated Encephalomyelitis, Multiple Sclerosis, Relapsing-Remitting, Head and Neck
Multiple Sclerosis, NMO, anti-MOG, Acute Disseminated Encephalolmyelitis
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HOPE in Action Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients

The primary objective of this study is to determine if an HIV-infected donor liver (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications
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studyfinder@utsouthwestern.edu
David Wojciechowski
188709
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03734393
STU-2019-0831
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Inclusion Criteria:

• Participant meets the standard criteria for liver transplant at the local center.
• Participants being listed for a simultaneous liver kidney (SLK) are eligible if participants meet the standard criteria for both organs.
• Participant is able to understand and provide informed consent.
• Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE) Act Safeguards and Research Criteria.
• Documented HIV infection (by any licensed assay or documented history of detectable HIV-1 RNA).*
• Participant is ≥ 18 years old.
• Opportunistic complications: prior history of certain opportunistic infections is not an exclusion if the participant has received appropriate therapy and has no evidence of active disease. Medical record documentation should be provided whenever possible.
• CD4+ T-cell count: ≥ 100/µL within 16 weeks prior to transplant if no history of AIDS-defining infection; or ≥ 200 μL if history of opportunistic infection is present.
• HIV-1 RNA is below 50 RNA/mL.* Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements > 200 copies/mL. *Organ recipients who are unable to tolerate anti-retroviral therapy (ART) due to organ. failure or recently started ART may be eligible despite a detectable viral load if safe and effective ART to be used by the recipient after transplantation is described.
• Participant must have or be willing to start seeing a primary medical care provider with expertise in HIV management.
• Participant is willing to comply with all medications related to participant's transplant and HIV management.
• For participants with a history of aspergillus colonization or disease, no current clinical evidence of active disease.
• Agreement to use contraception.
• Participant is not suffering from significant wasting (e.g. body mass index < 21) thought to be related to HIV disease.
Exclusion Criteria:

• Participant has a history of progressive multifocal leukoencephalopathy (PML), or primary central nervous system (CNS) lymphoma.*
• Participant is pregnant or breastfeeding. (Note: Participants who become pregnant post-transplant will continue to be followed in the study and will be managed per local site practice. Women that become pregnant should not breastfeed.)
• Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Other: HIVD+/R+
HIV
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Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants (ValEAR)

The overall goal of this study is to determine the clinical benefit and safety of antiviral therapy for asymptomatic congenital cytomegalovirus (cCMV) infected hearing-impaired infants. We will conduct a multi-center double-blind randomized placebo-controlled trial to determine whether hearing-impaired infants with asymptomatic cCMV have better hearing and language outcomes if they receive valganciclovir antiviral treatment. We will also determine the safety of antiviral valganciclovir therapy for asymptomatic cCMV-infected hearing impaired infants. This study will be unique in that the cohort enrolled will only include hearing-impaired infants with asymptomatic cCMV. Primary Objective: To determine if treatment of cCMV-infected hearing impaired infants with isolated hearing loss with the antiviral drug valganciclovir reduces the mean slope of total hearing thresholds over the 20 months after randomization compared to untreated cCMV-infected infants with isolated hearing loss. Main Secondary Objectives: 1. To determine if valganciclovir treatment improves the following outcomes when compared to the control group: 1. The slope of best ear hearing thresholds over the 20 months after randomization. 2. The MacArthur-Bates Communicative Development Inventory (CDI) percentile score for words produced at 20 months of age. 2. To evaluate safety measures based on all grade 3 or greater new adverse events designated by the NIAID Division of AIDS (DAIDS) toxicity tables.
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Kenneth Lee
93887
All
1 Month to 12 Months old
Phase 2
This study is NOT accepting healthy volunteers
NCT03107871
STU-2019-1329
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Inclusion Criteria:

• Age greater than or equal to 1 month and less than or equal to 12 months at the time of randomization; AND
• Positive congenital CMV by urine culture or polymerase chain reaction test(PCR), OR saliva culture or PCR followed by confirmatory urine PCR by 21 days of age, OR urine culture or PCR after 21 days of age followed by newborn dry blood spot PCR; AND
• Confirmed sensorineural hearing loss (SNHL) by auditory brainstem response (ABR) testing. For ABR assessments, hearing loss is defined as levels greater than 25 dB normal hearing levels (NHL) at 1, 2, or 4 kHz in one or both ears.
Exclusion Criteria:

• Imminent demise; OR
• Known hypersensitivity reaction to valganciclovir, ganciclovir, or any components of the investigational product formulation; OR
• ALT (Alanine Aminotransferase) five times baseline U/L, hepatomegaly, or significant gastrointestinal disorders (e.g., eosinophilic esophagitis, ulcerative colitis); OR
• Absolute neutrophil count (ANC) less than 500 cells/mm^3, Hemoglobin less than 8 g/dL, or platelets less than 50,000/mm^3, splenomegaly, or significant hematologic disorders (e.g., hemophilia, leukemia, sickle cell anemia); OR
• Creatinine clearance less than 60 mL/min/1.73m^2 or significant renal disorders (e.g., nephrotic syndrome); OR
• Receiving other antiviral medications or immune globulin therapy; OR
• Receiving other investigational drugs; OR
• Breast feeding from a mother receiving antiviral or immunosuppressive medication; OR
• Known HIV positive mother (risk of immunosuppression); OR
• Subject is currently using list of prohibited medication specified by the package insert; OR
• Other known cause contributing to SNHL (e.g., meningitis, aminoglycoside ototoxicity); OR
• Bilateral profound SNHL or auditory neuropathy spectrum disorder; OR
• Existing conductive hearing loss or mixed permanent hearing loss is present; OR
• Evidence of intracranial calcification; OR
• Evidence of hydrocephalus; OR
• Microcephaly; OR
• Presence of petechiae; OR
• Intrauterine growth retardation; OR
• Chorioretinitis, optic atrophy or pale optic nerves; OR
• Parent or guardian unable to speak English or Spanish; OR
• Subject exposed to a language other than English or Spanish a majority of the time; OR
• Subject unable to complete hearing assessments or parent/guardian unable to complete communication questionnaires; OR
• < 32 weeks gestational age at birth; OR
• Weight at the time of birth < 1800 g.
Drug: Valganciclovir, Drug: Simple Syrup
CMV, Cmv Congenital, Congenital Cmv, SNHL, Sensorineural Hearing Loss, Ear
valganciclovir
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Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult Patients With COVID-19

The primary objectives are: Phase 1 - To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo - To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral shedding of SARS-CoV-2 Phase 2 • To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral shedding of SARS-CoV-2 Phase 3 • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo
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Satish Mocherla
189623
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04425629
STU-2020-0838
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Key
Inclusion Criteria:

• Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal [OP], or saliva) ≤72 hours prior to randomization. A historical record of positive result from test conducted ≤72 hours prior to randomization is acceptable
• Meets 1 of the following 2 criteria: 1. Symptomatic Cohort (All Phases): Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤7 days before randomization or 2. Asymptomatic Cohort (Phase 2): Meets all of the following:
• Has had no symptoms consistent with COVID-19 (as determined by the investigator) occurring at any time <2 months prior to randomization
• Has had no positive SARS-CoV-2 test results from a sample collected >7 days prior to randomization
• Has had no known contact (of any duration) with an individual who has confirmed COVID-19 or confirmed positive SARS-COV-2 test result >14 days prior to randomization.
• Has experienced COVID-19 symptoms for <7 days
• Has symptoms consistent with COVID-19, as determined by investigator, with onset ≤7 days before randomization Key
Exclusion Criteria:

• Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to COVID-19
• Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
• Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 EUA approved treatments, where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening NOTE: Other Protocol defined Inclusion/Exclusion criteria apply
Drug: REGN10933+REGN10987 combination therapy, Drug: Placebo
COVID-19
Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), coronavirus
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Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS-5734™) in Participants From Birth to < 18 Years of Age With Coronavirus Disease 2019 (COVID-19) (CARAVAN)

The primary objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of remdesivir (RDV) in participants with laboratory-confirmed coronavirus disease 2019 (COVID-19) aged 0 days to < 18 years.
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Paul Sue
157043
All
up to 18 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT04431453
STU-2020-0630
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Key
Inclusion Criteria:

• Aged < 18 years of age who meet one of the following weight criteria (where permitted according to local law and approved nationally and by relevant institutional review board (IRB) or independent ethics committee (IEC)).
• a) Cohort 1: ≥ 12 years to < 18 years of age and weight at screening ≥ 40 kg
• b) Cohorts 2-4: ≥ 28 days to < 18 years of age and weight at screening ≥ 3 kg and < 40 kg
• c) Cohort 5: ≥ 14 days to < 28 days of age, gestational age > 37 weeks and weight at screening ≥ 2.5 kg
• d) Cohort 6: 0 days to < 14 days of age, gestational age > 37 weeks and birth weight of ≥ 2.5 kg
• e) Cohort 7: 0 days to < 56 days of age, gestational age ≤ 37 weeks and birth weight of ≥ 1.5 kg
• f) Cohort 8: < 12 years of age and weight at screening ≥ 40 kg
• Severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR)
• Hospitalized and requiring medical care for coronavirus disease 2019 (COVID-19) Key
Exclusion Criteria:

• Concurrent treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing
• Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
• Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2 using Schwartz formula for individuals ≥ 1 year of age
• Creatinine above protocol specified thresholds for < 1 year of age
• Positive pregnancy test at Screening only for female of child bearing potential. Note: If female participants who become pregnant during the study or are discovered to be pregnant after receiving at least one dose may continue study drug, after discussion with the investigator
• On renal replacement therapies (intermittent hemodialysis (iHD), peritoneal dialysis (PD), continuous renal replacement therapy (CRRT)) Note: Other protocol defined Inclusion/Exclusion criteria may apply
Drug: Remdesivir
COVID-19
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Convalescent Plasma in Outpatients With COVID-19 (C3PO)

The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration. This study will adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.
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studyfinder@utsouthwestern.edu
Ahamed Idris
58880
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04355767
STU-2020-0834
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Inclusion Criteria:

• One or more symptoms of COVID-19 illness and laboratory-confirmed SARS-CoV-2 infection
• Has at least one study defined risk factor for severe COVID-19 illness
• Clinical team deems stable for outpatient management without supplemental oxygen
• CP available at the site at the time of enrollment
• Duration of symptoms ≤ 7 days at ED presentation
• Informed consent from subject
Exclusion Criteria:

• Age less than 18 years
• Prisoner or ward of the state
• Presumed unable to complete follow-up assessments
• Prior adverse reaction(s) from blood product transfusion
• Receipt of any blood product within the past 120 days
• Treating clinical team unwilling to administer 300 ml fluid
• Enrollment in another interventional trial for COVID-19 illness
Biological: Convalescent Plasma, Biological: Saline
Covid19
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Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment

The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale on Day 11.
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studyfinder@utsouthwestern.edu
Mamta Jain
41138
All
12 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04292730
STU-2020-0258
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Key
Inclusion Criteria:

• Willing and able to provide written informed consent prior to performing study procedures (participants ≥ 18 years of age) or assent (participants ≥ 12 and < 18 years of age) prior to performing study procedures. For participants ≥ 12 and < 18 years of age, a parent or legal guardian willing and able to provide written informed consent prior to performing study procedures
• Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
• Currently hospitalized and requiring medical care for COVID-19
• Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening
• Radiographic evidence of pulmonary infiltrates Key
Exclusion Criteria:

• Participation in any other clinical trial of an experimental treatment for COVID-19
• Concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2
• Requiring mechanical ventilation at screening
• Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
• Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of age Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Drug: Remdesivir, Drug: Standard of Care
COVID-19
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