StudyFinder
Search Results Within Category "Infectious Diseases "
13 Study Matches
National Liver Cancer Screening Trial (TRACER)
The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible patients will be randomized in a 1:1 fashion to Arm A using semi-annual ultrasound and AFP-based screening or Arm B using semi-annual screening using GALAD alone. Randomization will be stratified by sex, enrolling site, Child Pugh class (A vs. B), and HCC etiology (viral vs. non-viral). Patients will be recruited from 15 sites (mix of tertiary care and large community health systems) over a 3-year period, and the primary endpoint of the phase IV trial, reduction in late-stage HCC, will be assessed after 5.5 years.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Amit Singal
ALL
18 Years to 85 Years old
PHASE4
NCT06084234
STU-2023-0842
Inclusion Criteria:
Patient must meet all of the following inclusion criteria:
• Adult patients ages 18-85 with cirrhosis from any etiology or with chronic hepatitis B with a PAGE-B score greater than 9 within 12 months of enrollment
• Patient is eligible for HCC surveillance according to treating physician or by the site investigator
• Able to provide informed consent
• Life expectancy \>6 months (after consent) as determined by the treating provider or site investigator
Exclusion Criteria:
Patient will be excluded for any of the following exclusion criteria:
• Child Pugh C cirrhosis
• History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma
• History of solid nodule on baseline ultrasound (i.e., lesion 1cm or greater) within 9 months prior to consent without subsequent diagnostic CT/MRI demonstrating benign nature)
• AFP \>20 ng/mL within 6 months prior to consent, in the absence of a contrast-enhanced CT or MRI within 6 months of AFP (before or after) level demonstrating lack of suspicious liver lesions
• Newly diagnosed LR-3 greater than or equal to 1 cm within 6 months prior to consent
• History of LR-4, LR-5, or LR-M on multi-phase CT or contrast-enhanced MRI within 6 months prior to consent
• Presence of another active cancer besides non-melanomatous skin cancer or indolent cancer under active surveillance (e.g., prostate cancer or renal cell carcinoma) within the 2 years prior to consent
• Patient's provider is planning to use MRI- or CT- based surveillance moving forward
• History of a transjugular intrahepatic portosystemic shunt (TIPS)
• History of Fontan associated liver disease or cardiac cirrhosis
• History of solid organ transplantation
• Actively listed for liver transplantation
• Diagnosis of alcohol-associated hepatitis within 3 months prior to consent
• Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis)
• In patients with primary sclerosing cholangitis (PSC): Current active cholangitis within 90 days prior to consent
• Known or documented habitual non-adherence to previous research studies or medical procedures or unwillingness to adhere to protocol (e.g., unwilling to obtain consent or samples)
• In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 60 days prior to consent
• Known pregnancy at consent
• Active warfarin use
DIAGNOSTIC_TEST: GALAD, DIAGNOSTIC_TEST: Liver Ultrasound with or without AFP
Liver Cancer, Carcinoma, Hepatocellular, Hepatitis B, Liver Cirrhosis, Liver
Hepatocellular carcinoma surveillance, GALAD, Alpha Fetoprotein
UT Southwestern; Parkland Health & Hospital System
Mitoquinone/Mitoquinol Mesylate as Oral and Safe Postexposure Prophylaxis for Covid-19
Adults who do not have major health, kidney, gastrointestinal disease will be randomized to receive oral mitoquinone/mitoquinol mesylate (Mito-MES) versus placebo to prevent the development and progression of COVID-19 after high-risk exposure to a person with confirmed SARS-CoV-2 infection.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Theodoros.Kelesidis@UTSouthwestern.edu
Theodoros Kelesidis
All
18 Years to 65 Years old
Phase 2
NCT05886816
STU-2023-0524
Inclusion Criteria:
Age 18-65 years old Asymptomatic (no symptoms of viral infection) on study entry High risk
exposure without use of masks to confirmed case of COVID-19 Members in a household one of
which is a confirmed case of COVID-19 Negative baseline SARS-COV-2 diagnostic test
Exclusion Criteria:
• Women with variations in physiological functions due to hormones that may effect immune function and (transgender, pregnant, breastfeeding)
• Specific significant clinical diseases [cardiovascular disease (such as coronary artery/vascular disease), heart disease (such as congestive heart failure, cardiomyopathy, atrial fibrillation), lung disease (such as chronic obstructive pulmonary disease, asthma, bronchiectasis, pulmonary fibrosis, pleural effusions), kidney disease (glomerular filtration rate or GFR less than 60 ml/min/1.73 m2), liver disease (such as cirrhosis, hepatitis), major immunosuppression (such as history of transplantation, uncontrolled HIV infection, cancer on active chemotherapy] based on history. Participants with well controlled HIV (CD4 count > 500 cells/mm^3 and HIV viral load < 50 copies/ml) and people with remote history of cancer not on active treatment will be allowed to participate.
• History of known gastrointestinal disease (such as gastroparesis) that may predispose patients to nausea
• History of auto-immune diseases
• Chronic viral hepatitis
• Use of systemic immunomodulatory medications (e.g. steroids) within 4 weeks of enrollment
• Any participant who has received any investigational drug within 30 days of dosing
• History of underlying cardiac arrhythmia
• History of severe recent cardiac or pulmonary event
• A history of a hypersensitivity reaction to any components of the study drug or structurally similar compounds including Coenzyme Q10 and idebenone
• Unable to swallow tablets
• Use of any investigational products within 4 weeks of enrollment
• Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
• Eligible for other FDA approved treatment for post-exposure prophylaxis against SARS-CoV-2
• Use of Coenzyme Q10 or Vitamin E < 120 days from enrollment
Drug: Mitoquinone/mitoquinol mesylate, Other: Placebo
COVID-19, Lung/Thoracic, Nose, SARS-CoV Infection
SARS-CoV Infection, COVID-19, Post-exposure prophylaxis
UT Southwestern
Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients (SAFE KIDNEY II)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in kidney transplant recipients. This study has an operationally seamless phase II/III design. The phase II part will evaluate the safety of AntiBKV in kidney transplant recipients and establish antiviral proof of concept. The phase II part includes a dose-comparison part to generate additional PK and PD data of AntiBKV. The phase III part will assess the efficacy of AntiBKV in kidney transplant recipients. For both the phase II and phase III parts, participants will be randomized to receive either four doses of AntiBKV or four doses of placebo (every four weeks). In phase II, 60 participants will be first randomized (1:1) to receive either four doses of 1,000 mg of AntiBKV or placebo. In an additional dose-comparison extension, another 30 participants will be enrolled and randomized (1:1:1) to receive either four doses of 1,000 mg AntiBKV, four doses of 500 mg AntiBKV, or placebo. Based on a Day 141 analysis after phase II the sample size for the phase III part of the trial will be defined. Both the phase II and phase III parts will follow identical study assessments and schedules for participants. Eligible participants will receive an intravenous infusion of the investigational medicinal product (IMP) that will be administered four times at a four-week interval. For the first ten participants enrolled in the study, the infusion time will be at least 60 minutes. Provided there are no safety concerns observed with the first ten participants the duration of subsequent infusions will be at least 30 minutes. After administration of the final dose, participants will return as out participants for periodic safety, BKV DNAemia, and PK follow-up assessments until the end of the trial visits, 26 weeks post last IMP application. Regular kidney biopsies will be performed at baseline (prior to infusion) and on Day 141 (8 weeks after full dosing). An additional biopsy will be taken on Day 267 (optional) and if clinically indicated.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Elaine.Bonilla@UTSouthwestern.edu
David Wojciechowski
ALL
18 Years and over
PHASE2
NCT05769582
STU-2023-0350
Inclusion Criteria:
• Male or female aged 18 years or older
• Kidney transplantation within 24 months prior to enrollment
• Kidney transplant recipient with first-time BKV DNAemia (evaluated during routine clinical monitoring by the local laboratory and acknowledged by a physician within four months prior to Day 1). BKV DNAemia is either defined by BKV-DNAemia of one time \>10,000 copies/mL, or \>1,000 copies/mL sustained for at least one week (confirmed by two consecutive measurements. Note: The second, most recent laboratory value must be acknowledged by a physician within four months prior to Day 1)
• Kidney transplant recipients with adequate and/or stable allograft function as indicated by estimated glomerular filtration rate ((e)GFR) ≥ 30 mL/min
• Female subjects (if of childbearing potential) must agree to use adequate and reliable contraceptive measures throughout their participation in the trial. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• Ability to provide written informed consent
Exclusion Criteria:
• Patients with previous diagnosis of BKV DNAemia (defined as one time \> 10,000 copies/mL, or \> 1,000 copies/mL sustained for at least one week (confirmed by two consecutive measurements) since last kidney transplantation
• Known hypersensitivity to any component of the IMP
• Transplanted kidney disease with an estimated glomerular filtration rate ((e)GFR) \< 30 mL/minute at screening
• Uncontrolled acute or chronic infection other than BKV infection at screening which might interfere with study participation at the discretion of the investigator
• Recipients who are treated or planned to be treated with a mTOR inhibitor or belatacept as part of their immunosuppression regimen post-transplantation at the time of enrollment and during the study period
• Recipients who are treated or planned to be treated during study participation with leflunomide at the time of enrollment and during the study period
• Recipients who in the opinion of the investigator are likely to require antibody-depletion therapy during trial participation. Antibody-depletion therapies include but are not necessarily limited to plasmapheresis, immunoadsorption, and intravenous immunoglobulins (IVIg)
• Recipients with active kidney transplant rejection or FSGS
• Recipients who have medical conditions or receive concomitant medications that prevent the recipient from undergoing allograft biopsy
• Recipients with known DSA (de novo or pre-transplantation). Kidney transplant recipients with low-level pretransplant DSAs (\< 1000 mean fluorescence intensity (MFI)) can be included if no impact on the study assessments is expected by the discretion of the investigator.
• (exclusion criterium deleted)
• Recipients with extremely high BKV DNAemia (\> 10,000,000 copies/ml) or hemorrhagic cystitis
• Recipients who in the opinion of the investigator are likely to develop recurrent native kidney disease (e.g. IgA nephritis, FSGS, C3 glomerulonephritis)
• Recipients with a functionally significant ureteral stricture
• Pregnant or nursing (lactating) women
• Known current active or latent TB or any history, in the opinion of the investigator, that confers a risk of reactivation of latent TB and precludes the use of conventional immunosuppression
• History of splenectomy or asplenia
• Any condition, that in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of the participant safety data or study results
• History of malignancy within the past five years, except completely excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ at least two years prior to screening
• Participation in another interventional clinical trial during trial participation or within 30 days prior to the IMP dosing or planned dosing
• History of alcoholism or drug addiction within one year of screening. Substance use disorder will be an exclusion criterion, at investigator's discretion.
BIOLOGICAL: Anti-BK polyomavirus (AntiBKV)
BK Viremia, BKV DNAemia
UT Southwestern
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Olakunbi.Latona@UTSouthwestern.edu
Mamta Jain
ALL
18 Years and over
PHASE4
NCT05822583
STU-2023-0123
Inclusion Criteria:
* Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non-NAT test \[list of approved tests in the PIM\] within 14 days of randomization.
* Requiring hospitalization for the management of COVID-19
* Has evidence of COVID-19 pneumonia (PNA) defined as either receiving supplementary oxygen ≤2L of low flow oxygen with evidence of airspace disease on chest imaging (X ray, computer tomography or ultrasound) OR receiving supplementary oxygen \>2L and \<10 L of low flow oxygen.
* Currently receiving or planned to receive (ordered) one IM drug (for example, a corticosteroid or baricitinib) as part of treatment of COVID-19 prior to randomization.
* Has started supplemental oxygen for the treatment of COVID-19 within the past 5 calendar days. Patients on home oxygen are eligible if current oxygen flow rate is increased from baseline and other above criteria are met.
* Investigator agrees that the pneumonia is due to COVID-19.
Exclusion Criteria:
* Oxygen requirement of ≥10L or more of low flow oxygen (or equivalent if using Venturi mask, etc), or requiring either HFNO, NIV, IMV, or ECMO.
* Participant has received more than one baseline IM for treatment of the current COVID-19 infection at time of trial enrollment. (Examples: corticosteroid, baricitinib, tocilizumab, anakinra, abatacept, or infliximab.)
* Participant anticipated to not meet all inclusion criteria within 24 hours of randomization in the opinion of the investigator.
* Allergy to investigational agent.
* Neutropenia (absolute neutrophil count \<1000 cells/μL) (\<1.0 x 10 3 /μL or \<1.0 G/L) on most recent lab within 2 calendar days of randomization.
* Lymphopenia (absolute lymphocyte count \<200 cells/μL) (\<0.20 x 10 3 /μL or \<0.20 G/L) on most recent lab within 2 calendar days of randomization.
* Known or suspected active or recent serious infection (bacterial, fungal, viral, or parasitic infection, excepting SARS-CoV-2) that in the opinion of the investigator could constitute a risk when taking investigational agent. Note: Broad spectrum empiric antibiotic usage does not exclude participation.
* Known or suspected history of untreated tuberculosis (TB). TB diagnosis may be suspected based on medical history and concomitant therapies that would suggest TB infection. Participants are also excluded if they have known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required).
* Have received any live vaccine (or live attenuated) within 3 months before screening or intend to receive a live vaccine (or live attenuated) during the trial. Use of prior non-live (inactivated) vaccinations is allowed for all participants, including any vaccine for COVID-19.
* Pre-existing immunomodulation or immunosuppression that meets any of the following: Participant has received abatacept for an indication other than COVID- 19 within 5 half-lives (65 days) of enrollment (Abatacept elimination half-life is 13.1 days.) Participant is receiving immune modulatory therapy for autoimmune, transplant management or another indication AND has one or more of the following: evidence of active infection (other than COVID-19) or has required reduction in their immune modulatory therapy in the preceding 6 months due to infectious complication (routine reduction as SOC is not an exclusion) or has required intensification in immunotherapy within the preceding 6 months due to organ rejection/worsening underlying disease status (e.g., intensification with an additional agent on top of usual immunosuppressive regimen)
* Participant has recently received or is anticipated to require immune modulatory agents for their underlying disease including chemotherapeutic treatments likely to induce neutropenia (\<1.0 x 10 9 cells/µL) or lymphopenia (\<1.0 x 10 9 cells/µL)
* Participant has untreated advanced HIV (known CD4 \<200 in the past 6 months) AND is not established on antiretroviral therapy
* Pregnancy
* Breastfeeding
* Co-enrollment in other trials not predetermined to be compatible with this trial.
* In the investigator's judgment, the patient has any advanced organ dysfunction that would not make participation appropriate.
* The treating clinician expects inability to participate in trial procedures or participation would not be in the best interests of the patient. DRUG: abatacept infusion, DRUG: Placebo group
COVID-19
UT Southwestern; Parkland Health & Hospital System
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)
Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi \&; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Olakunbi.Latona@UTSouthwestern.edu
Mamta Jain
ALL
18 Years and over
PHASE3
NCT05605093
STU-2022-1124
Inclusion Criteria:
* Age ≥18 years.
* Informed consent for trial participation.
* Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) with signs and/or symptoms of a respiratory infection.
* Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non- NAT test \[list of approved tests is in the PIM\] collected within the prior 14 days.
* Onset of symptoms attributable to SARS-CoV2 infection occurred within 14 days before randomization.
* Hospitalized for the management of COVID-19, with signs and/or symptoms suggestive of lower respiratory tract infection.
Exclusion Criteria:
* The patient is expected to be discharged from the hospital within the next 24 hours.
* Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization.
* Use of a strong CYP3A inducer within 14 days prior to enrollment
* Moribund condition, defined as prior cardiac arrest during this hospitalization and life expectancy less than 48 hours of randomization.
* Patient undergoing comfort care measures only such that treatment focuses on end-of- life symptom management over prolongation of life.
* Expected inability or unwillingness to participate in study procedures.
* In the opinion of the investigator, participation in a trial is not in the best interest of the patient.
* Allergy to investigational agent or vehicle
* Use of a concomitant medication that is contraindicated due to a drug-drug interaction with S-217622
* Moderate to severe hepatic impairment (i.e., Child-Pugh class B or C) or acute liver failure.
* Known estimated glomerular filtration rate (eGRF) \<30 mL/min/1.73m 2
* Continuous renal replacement therapy or chronic dialysis
* Current pregnancy
* Current breastfeeding and unwillingness to defer breastfeeding for 30 days after the last dose of investigational agent.
* Women of child-bearing potential who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception through 30 days from the last dose of the investigational agent.
* Men who are unwilling to abstain from sexual intercourse with women of child- bearing potential or to use barrier contraception through 30 days from the last dose of the investigational agent.
* Inability to take investigational agent in tablet form by mouth. DRUG: Shionogi Protease Inhibitor (S-217622), DRUG: placebo
COVID-19, Other
UT Southwestern; Parkland Health & Hospital System
Study of Tecovirimat for Human Mpox Virus (STOMP)
A5418 is a randomized, placebo-controlled, double-blind study to establish the efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive HMPXV disease.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Diana.TrianaGomez@UTSouthwestern.edu
Ellen Kitchell
ALL
Not specified
PHASE3
NCT05534984
STU-2022-0871
Inclusion Criteria (All participants; Arms A, B, and C):
• Laboratory-confirmed or presumptive HMPXV infection.
• HMPXV illness of \<14 days duration immediately prior to study entry.
• At least one active (not yet scabbed) skin lesion, mouth lesion, or proctitis with or without visible ulcers.
• Non-pregnant people of reproductive potential must agree to use at least one effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through the end of study participation. Additional Inclusion Criteria for Arms A and B:
• Age ≥18 years at the time of study entry Additional Inclusion Criteria for Arm C; Participants who meet the above entry criteria who also meet any of the following criteria will be registered to Arm C:
• Participants age \<18 years at the time of study entry
• Those with severe HMPXV disease Those with or without severe disease and with one or more of the following will also be enrolled into Arm C: * Severe immunosuppression * Skin conditions placing the person at higher risk for disseminated infection Exclusion Criteria (All participants; Arms A, B, and C):
• Prior or concomitant receipt of tecovirimat (e.g., under an alternative access mechanism.
• Planned initiation of intramuscular cabotegravir/rilpivirine during study drug administration or for two weeks following completion of study drug administration. Participants who are stable on long-acting intramuscular cabotegravir/rilpivirine may enroll.
• Participants who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study.
• Participants who require intravenous dosing of tecovirimat.
• Laboratory-confirmed or presumptive HMPXV infection.
• HMPXV illness of \<14 days duration immediately prior to study entry.
• At least one active (not yet scabbed) skin lesion, mouth lesion, or proctitis with or without visible ulcers.
• Non-pregnant people of reproductive potential must agree to use at least one effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through the end of study participation. Additional Inclusion Criteria for Arms A and B:
• Age ≥18 years at the time of study entry Additional Inclusion Criteria for Arm C; Participants who meet the above entry criteria who also meet any of the following criteria will be registered to Arm C:
• Participants age \<18 years at the time of study entry
• Those with severe HMPXV disease Those with or without severe disease and with one or more of the following will also be enrolled into Arm C: * Severe immunosuppression * Skin conditions placing the person at higher risk for disseminated infection Exclusion Criteria (All participants; Arms A, B, and C):
• Prior or concomitant receipt of tecovirimat (e.g., under an alternative access mechanism.
• Planned initiation of intramuscular cabotegravir/rilpivirine during study drug administration or for two weeks following completion of study drug administration. Participants who are stable on long-acting intramuscular cabotegravir/rilpivirine may enroll.
• Participants who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study.
• Participants who require intravenous dosing of tecovirimat.
DRUG: Tecovirimat Oral Capsule, DRUG: Placebo, DRUG: Tecovirimat Oral Capsule (Open Label)
MPOX
HMPXV
Parkland Health & Hospital System
Outpatient Treatment With Anti-Coronavirus Immunoglobulin (OTAC)
The primary objective of the Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC) (INSIGHT 012) trial is to compare the safety and efficacy of a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) versus placebo among adults with recently diagnosed severe acute respiratory syndrome - coronavirus 2 (SARS-CoV2) infection who do not require hospitalization. The primary endpoint of this double-blind randomized trial is a five-category ordinal outcome that assesses the participant's clinical status seven days after the infusion of hIVIG or placebo. 1. Asymptomatic and no limitations in usual activity due to COVID-19 2. Mild COVID-19 illness or minor limitations to usual activity 3. Moderate COVID-19 illness and with major limitations to usual activity 4. Severe COVID-19 or serious disease manifestation from COVID-19 5. Critical illness from COVID-19 or Death Two strata of participants will be identified for analysis purposes. Stratum 2 will be participants who receive direct-acting antivirals (DAAs) or other anti-SARS-CoV2 agents that are approved/available and recommended for use as part of standard of care (SOC), estimated to be about 20% of participants. Stratum 1 will be participants who do not receive this agents, estimated to be about 80% of participants.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Yolanda.Reedy@UTSouthwestern.edu
Mamta Jain
ALL
18 Years and over
PHASE3
NCT04910269
STU-2021-0399
Inclusion Criteria:
* Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with an immunosuppressed condition.
* Positive test for SARS-CoV-2 within ≤5 days (if \>1 test, the first positive is within ≤5 days). Tests may include an institutional-based nucleic acid amplification test (NAAT), or any protocol-approved rapid test.
* Within ≤5 days from symptom onset, if symptomatic from current SARS-CoV-2 infection.
* Agrees to not participate in another clinical trial for the treatment or management of SARS-CoV-2 infection through Day 7, or until hospitalized or significant disease progression if prior to Day 7 (defined by ordinal category 4 or 5).
* Participant provides written informed consent prior to study procedures, and understands and agrees to adhere to planned study procedures through Day 28.
Ongoing immunosuppressive condition or immunosuppressive treatment, includes:
• Steroids equivalent to prednisone \> 10 mg/day for at least the last 28 days
• Rheumatologic or autoimmune disorder treated with a biologic or non-biologic immunosuppressive therapy
• Antirejection medicine after solid organ or stem cell transplantation
• Cancer treatment with systemic chemotherapy, biologic and/or cell-based therapy in the last 12 months
• Primary or acquired severe B- or T-lymphocyte immune dysfunction
• HIV infection
• Splenectomy or functional asplenia
Exclusion Criteria:
* Asymptomatic and had prior symptoms from the current infection that have now resolved (for \>24 hours).
* Asymptomatic and has received a vaccination for COVID-19 (≥1 dose).
* Undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes).
* Evidence of pneumonia and/or hypoxia due to COVID-19 (NOTE: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level).
* Prior receipt of immunoglobulin product or passive immune therapy for SARS-CoV-2 in the past 90 days (i.e., convalescent plasma, SARS-CoV-2 monoclonal antibodies, or any IVIG).
* Any of the following thrombotic or procoagulant conditions or disorders:
• acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization.
• prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin III, protein C, or protein S. * History of hypersensitivity to blood, plasma or IVIG excipients. * Known immunoglobulin A (IgA) deficiency or anti-IgA antibodies. * In the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.
BIOLOGICAL: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG), OTHER: Placebo
SARS-CoV2 Infection, Covid19, COVID
immunotherapy, hIVIG, early treatment
UT Southwestern; Parkland Health & Hospital System
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) (POPS or POP02)
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Aruna.Ayalasomayajula@UTSouthwestern.edu
Mia Maamari
ALL
0 Years to 20 Years old
NCT04278404
STU-2021-0176
Inclusion Criteria:
• Participant is \< 21 years of age
• Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
• (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment
Exclusion Criteria:
• Participant has a known pregnancy Below exclusion criteria apply only to: Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)
• Has had intermittent dialysis within previous 24 hours
• Has had a kidney transplant within previous 30 days
• Has had a liver transplant within previous 1 year
• Has had a stem cell transplant within previous 1 year
• Has had therapeutic hypothermia within previous 24 hours
• Has had plasmapheresis within the previous 24 hours
• Has a Ventricular Assist Device
• Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
DRUG: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
Bronchopulmonary Dysplasia, Heart Failure, Pulmonary Arterial Hypertension, Hypertension, Hyperphosphatemia, Pain, Pneumonia, Insomnia, Menorrhagia, Down Syndrome, Hemophilia, Fibrinolysis, Hemorrhage, Coronavirus Infection (COVID-19), Urinary Tract Infections in Children, Primary Hyperaldosteronism, Edema, Hypokalemia, Skin Infection, Arrythmia, Asthma in Children, Adrenal Insufficiency, Attention Deficit Hyperactivity Disorder, Multisystem Inflammatory Syndrome in Children (MIS-C), Kawasaki Disease, Coagulation Disorder
Children’s Health
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Therese.Vallina@UTSouthwestern.edu
Jeffrey Tessier
All
Not specified
Phase 3
NCT03808922
STU-2022-0991
Inclusion Criteria:
• At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia.
• Immunocompromised, as defined by one or more of the following:
• Received an autologous or allogeneic hematopoietic stem cell transplantation (HSCT) at any time in the past
• Received a solid organ transplant at any time in the past
• Has been or is currently being treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past
• Has an immunodeficiency due to congenital abnormality (only applicable to subjects age < 18 years old) or pre-term birth (only applicable to subjects age ≤ 2 years old)
• Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid dependent respiratory virus
• If female, subject must meet one of the following conditions:
• Not be of childbearing potential or
• Be of childbearing potential and have a negative urine/serum pregnancy test and agrees to practice an acceptable method of contraception
• Non-vasectomized males are required to practice effective birth control methods
• Capable of understanding and complying with procedures as outlined in the protocol
• Provides signed informed consent prior to the initiation of any screening or study-specific procedures For COVID-19 sub study:
• Be ≥18 years of age
• Provide adequate medical history to permit accurate stratification (but health status may be healthy, high-risk conditions, or immunocompromised).
• Prior to SARS CoV 2 infection, has the ability to carry out self-care activities of daily living (basic ADL)
• Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with or without contrast, to involve at least 2 lobes of the lung.
• Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tract by at least one of the following samples
• Satisfy inclusion criteria #1, 4, 5, 6, 7 of the main study
Exclusion Criteria:
• Subjects may not be on hospice care or, in the opinion of the investigator, have a low chance of survival during the first 10 days of treatment
• Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2x ULN Note: Subjects with ALT/AST/ALP ≥ 3x ULN AND TB ≥2x ULN that have been chronically stable (for >1 year on more than one assessments) due to known liver pathology including malignancy (primary or metastasis), chronic medications, transplantation, or chronic infection will not be excluded
• Female subjects breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug
• Subjects taking any other investigational drug used to treat pulmonary infection.
• Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance
• Subjects with known hypersensitivity to DAS181 and/or any of its components
• Subjects with severe sepsis due to either their baseline SAD-RV infection or a concurrent viral, bacterial, or fungal infection and meet at least one of the following criteria:
• Has evidence of vital organ failure outside of the lung (e.g., liver, kidney)
• Requires vasopressors to maintain blood pressure For COVID-19 sub study:
• Subjects requiring invasive mechanical, Bi-PAP or CPAP ventilation at randomization.
• Subjects receiving any other investigational or empiric treatment for SARS-2-CoV (either as part of a clinical trial or under emergency approval (approved agents for the management of symptoms, e.g., fever, are permitted).
• Subjects who are known HIV-positive (and not undetectable at most recent HIV RNA assessment)
• Subjects who are currently taking immunomodulating biologics (e.g, interferons, interleukin)
• Subjects with severe sepsis due to either their SARS-CoV-2 infection or a concurrent viral, bacterial, or fungal infection and meeting at least one of the following criteria:
• Have evidence of vital organ failure outside of the lung (e.g., liver, kidney)
• Require vasopressors to maintain blood pressure
• Subjects meeting exclusion criteria #2, 3, 5 and 6 of the main study
Drug: DAS181, Drug: Placebo, Drug: DAS181 COVID-19, Drug: DAS181 OL
COVID-19, Lung/Thoracic, Lower Respiratory Tract Infection, Parainfluenza, Immunocompromised
Parainfluenza, PIV, Immunocompromised, Lower Respiratory Tract Infection, LRTI, COVID19, SARS-CoV-2, Coronavirus, Ansun
UT Southwestern
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score (TEAMMATE)
The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years. Half of the participants will receive everolimus and low-dose tacrolimus and the other half will receive tacrolimus and mycophenolate mofetil. The trial will determine which treatment is better at reducing the cumulative risk of coronary artery vasculopathy, chronic kidney disease and biopsy proven-acute cellular rejection without an increase in graft loss due to all causes (e.g. infection, PTLD, antibody mediated rejection).
Call 214-648-5005
studyfinder@utsouthwestern.edu, kara.lorduy@childrens.com
Ryan Butts
All
up to 21 Years old
Phase 3
NCT03386539
STU 122017-025
Inclusion Criteria:
• Orthotopic heart transplantation
• Age < 21 years at time of transplant
• Stable immunosuppression at the time of randomization with no contraindication to everolimus, tacrolimus, or mycophenolate mofetil
• Planned follow-up at a study site for the 30 month duration of the study.
• Subject or legal adult representative capable of providing informed consent (in general, assent will be sought for children aged 12 years or older).
Exclusion Criteria:
• Multi-organ transplant (e.g. heart-lung or heart-liver).
• Known hypersensitivity to everolimus, sirolimus, tacrolimus or mycophenolate mofetil (MMF), or to components of the drug products.
• Patients on maintenance corticosteroid therapy exceeding a dose equivalent of prednisone 0.1 mg/kg/day at randomization.
• High-risk for rejection defined as active rejection, recurrent (≥ 2 episodes of grade 2R rejection) cellular rejection, recurrent rejection (≥ 2 episodes of any grade) with hemodynamic compromise, steroid-resistant rejection or unresolved antibody-mediated rejection during the first 6 months post-heart transplant
• Graft dysfunction (LVEF <40% or wedge pressure >22 mmHg or cardiac index <2.2 L/min/m2)
• Stage 4 or 5 CKD (eGFR <30 ml/min/1.73 m2) or moderate proteinuria (urine protein to urine creatinine ratio >0.5 mg/mg).
• Active infection requiring hospitalization or treatment dose medical therapy.
• Patients with ongoing wound healing problems, clinically significant wound infection requiring continued therapy or other severe surgical complication in the opinion of the Site Principal Investigator.
• Fasting Serum Cholesterol ≥300 mg/dL OR greater than or equal to 7.75 mmol/L, AND fasting triglycerides ≥2.5x the upper limit of normal (ULN). Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication, and reduction of serum cholesterol and triglyceride levels to below exclusion ranges is confirmed.
• Uncontrolled diabetes mellitus.
• Diagnosis of post-transplant lymphoproliferative disorder (PTLD) during the first 6 months post-heart transplant.
• History of non-adherence to medical regimens.
• Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) and cannot discontinue the treatment
• Patients who are pregnant or breast-feeding or intend to get pregnant during the study period.
Drug: Everolimus, Drug: Tacrolimus, Drug: Mycophenolate Mofetil
Post-transplant Lymphoproliferative Disorder, Chronic Kidney Diseases, Pediatric Heart Transplantation, Immunosuppression, Cardiac Allograft Vasculopathy, Heart Transplant Failure and Rejection, Heart Transplant Infection
heart transplantation, children, everolimus, tacrolimus, mycophenolate mofetil, randomized clinical trial
Children’s Health
Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID-19 Registry (COVID-19)
Researchers are creating a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and to determine the variations in practice across hospitals.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Farzin.Ahmed@UTSouthwestern.edu
Sreekanth Cheruku
All
Not specified
NCT04323787
STU-2020-0355
Inclusion Criteria:
• COVID-19 PCR positive (within 7 days)
• COVID-19 PCR pending
• COVID-19 high clinical suspicion
Exclusion Criteria:
• Patient without Prior Research Authorization (applicable to Mayo Clinic sites)
• Non COVID-19 related admissions
• Repeated Admission to ICUs/Hospital
Other: observational
Coronavirus
COVID19
UT Southwestern; Parkland Health & Hospital System
Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections (DOMINIC)
This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive mold infection (PIMI).
Call 214-648-5005
studyfinder@utsouthwestern.edu, Aruna.Ayalasomayajula@UTSouthwestern.edu
Yeh-Chung Chang
All
120 Days to 21 Years old
NCT03827694
STU-2019-1188
Inclusion Criteria:
• Males or females age > 120 days and < 22 years at any participating site
• Have at least one of the following conditions associated with a known high incidence of IMI: hematopoietic stem cell transplantation (HSCT), aplastic anemia, or hematologic malignancy
• New (last 96 hours) radiographic evidence of at least one of the following: at least one nodular lesion greater than or equal to 5 mm in size, a cavitary lesion, a lesion with a halo sign, a lesion with a reverse halo sign, or a lesion with an air crescent sign
• Prolonged neutropenia (absolute neutrophil count < 500 cells/µl for a period of ≥ 5 consecutive days) in 30 days prior to qualifying chest MRI or CT scan date OR currently receiving systemic therapy for acute or chronic graft-versus-host disease (GVHD) on the date of the qualifying chest MRI or CT scan
• Subject consent or parental/guardian permission (informed consent) and if appropriate, child assent
Exclusion Criteria:
• Weight <3 kg, so as to not exceed 3 ml/kg in a single blood draw
• Previous inclusion in this study
Diagnostic Test: Non-Invasive Testing for PIMI
Lung/Thoracic, Pulmonary Invasive Mold Infections, Pulmonary Invasive Aspergillosis
Children’s Health
IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study) (ABATE)
The purpose of this study is to assess the safety and tolerability of two 5-day infusion cycles of IV gallium in adult patients with CF who are infected with NTM. Funding Source - FDA OOPD
Call 214-648-5005
studyfinder@utsouthwestern.edu, LYNN.FERNANDEZ@UTSouthwestern.edu
Raksha Jain
All
18 Years and over
Phase 1
NCT04294043
STU-2021-0279
Inclusion Criteria:
• Written informed consent obtained from subject or subject's legal representative
• Be willing and able to adhere to the study visit schedule and other protocol requirements
• Greater than or equal to 18 years of age at Visit 1
• Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
• Sweat chloride ≥ 60 milliequivalent (mEq)/liter by quantitative pilocarpine iontophoresis test (QPIT)
• Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
• Abnormal nasal potential difference (NPD) (change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV)
• Documentation of NTM culture positive defined as follows:
• Two positive NTM culture results from sputum (or BAL) at least 28 days apart (these are the two qualifying positive cultures)
• Both qualifying positive culture results include M. avium complex, M. abscessus complex, or both M. avium and M. abscessus
• Both qualifying positive culture results include the same species or subspecies
• No cultures negative for NTM since the first of the two qualifying positive culture results
• Current NTM species or subspecies has never been treated or previous treatment was associated with clearance of NTM and completed > 2 years prior to Day 1
• Forced expiratory volume in 1 second (FEV1) ≥ 25 % of predicted value at Screening
• Able to expectorate sputum
• Clinically stable with no significant changes in health status within 7 days prior to Day 1
• Enrolled in the CFF Cystic Fibrosis Foundation Patient Registry (CFFPR)
• Willing to discontinue chronic azithromycin use for the duration of the study
Exclusion Criteria:
• Any of the following abnormal lab values at screening:
• Hemoglobin <10g/dL
• Platelets <100,000/mm3
• White blood cells (WBC) < 4,500/mm3
• Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) ≥3 x upper limit of normal
• Serum creatinine > 2.0 mg/dl and ≥1.5 x upper limit of normal
• Ionized calcium ≤ lower limit of normal (only performed if total calcium is ≤ lower limit of normal)
• History of solid organ or hematological transplantation
• Use of bisphosphonates within 7 days prior to Day 1
• Known sensitivity to gallium
• Use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to Day 1
• In the opinion of the Investigator, features of active NTM disease are present (e.g., clinical worsening is likely due to NTM disease despite definitive treatment of co-pathogens and/or acute exacerbations)
• Undergoing treatment for NTM disease or anticipate beginning treatment within 3 months
• Current diagnosis of osteoporosis
• For people of childbearing potential:
• Positive pregnancy test at Visit 1 or
• Lactating or
• Unwilling to practice a medically acceptable form of contraception (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent), unless surgically sterilized or postmenopausal during the study
• For people able to father a child: unwilling to use adequate contraception (as determined by the investigator) during the study
• Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
• New initiation of chronic therapy (greater than 21 days) within 28 days prior to the Enrollment Visit
Drug: Gallium nitrate
Lung/Thoracic, Nontuberculous Mycobacterium Infection
Cystic Fibrosis, Gallium Nitrate, IV Gallium, Nontuberculous mycobacterium, NTM, Mycobacterium abscessus, mycobacterium avium
UT Southwestern