Search Results
within category "Infectious Diseases "
Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
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.
• 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:
1. Steroids equivalent to prednisone > 10 mg/day for at least the last 28 days
2. Rheumatologic or autoimmune disorder treated with a biologic or non-biologic
immunosuppressive therapy
3. Antirejection medicine after solid organ or stem cell transplantation
4. Cancer treatment with systemic chemotherapy, biologic and/or cell-based therapy in the
last 12 months
5. Primary or acquired severe B- or T-lymphocyte immune dysfunction
6. HIV infection
7. 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:
1. acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep
venous thrombosis within 28 days of randomization.
2. 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
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
1. Written informed consent obtained from subject or subject's legal representative
2. Be willing and able to adhere to the study visit schedule and other protocol
requirements
3. Greater than or equal to 18 years of age at Visit 1
4. 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)
5. 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
6. 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
7. Forced expiratory volume in 1 second (FEV1) ≥ 25 % of predicted value at Screening
8. Able to expectorate sputum
9. Clinically stable with no significant changes in health status within 7 days prior to
Day 1
10. Enrolled in the CFF Cystic Fibrosis Foundation Patient Registry (CFFPR)
11. Willing to discontinue chronic azithromycin use for the duration of the study
Exclusion Criteria:
1. 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)
2. History of solid organ or hematological transplantation
3. Use of bisphosphonates within 7 days prior to Day 1
4. Known sensitivity to gallium
5. Use of any investigational drug and/or participated in any interventional clinical
trial within 28 days prior to Day 1
6. 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)
7. Undergoing treatment for NTM disease or anticipate beginning treatment within 3 months
8. Current diagnosis of osteoporosis
9. 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
10. For people able to father a child: unwilling to use adequate contraception (as
determined by the investigator) during the study
11. 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
12. New initiation of chronic therapy (greater than 21 days) within 28 days prior to the
Enrollment Visit
Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus
(AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).
• Male or female >1 year of age.
• Has undergone allogeneic cell transplantation ≥21 days prior to randomization and
demonstrated engraftment with an absolute neutrophil count >500/mm^3, AND has one of
the following:
1. AdV viremia DNA ≥10,000 copies/mL at screening, OR
2. Two consecutive and rising AdV viremia DNA results of ≥1,000 copies/mL at
screening, AND
1. has absolute lymphocyte count <180/mm3, OR
2. has received T cell depletion.
• Contraceptive use by men and women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies and
refrain from donating sperm or eggs for at least 90 days after treatment completion.
• Willing and able to provide signed informed consent.
• Has an HLA type matching with at least 1 suitably matched and available posoleucel VST
line for infusion.
Exclusion Criteria:
• Grade >2 acute GVHD
• Ongoing therapy with high-dose systemic corticosteroids
• Grade 4 diarrhea
• Uncontrolled viral (other than AdV), bacterial, or fungal infection(s)
• Requirement for fraction of inspired oxygen >0.5 to maintain arterial oxygen
saturation >90% (via pulse oximetry) or need for mechanical ventilation.
• Prior therapy with anti-thymocyte globulin, alemtuzumab (Campath®), or other
immunosuppressive T cell monoclonal antibodies within 28 days prior to randomization.
• Prior donor lymphocyte infusion or CD34+ stem cell infusion within 21 days prior to
randomization.
• Use of vasopressors within 7 days prior to randomization.
• Use of any investigational antiviral agent, including brincidofovir, within 7 days
prior to randomization.
• Lactating female unwilling to discontinue nursing prior to randomization.
• Severe allergy to any component of posoleucel or history of severe prior reactions to
blood product transfusions.
• Positive for SARS-CoV-2 virus at screening.
Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE (ACTIV-4A)
This is a randomized, open label, adaptive platform trial to compare the effectiveness of
antithrombotic and additional strategies for prevention of adverse outcomes in COVID-19
positive inpatients
• ≥ 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
Inclusion Criteria for Arm E
Inclusion criteria contained in the master protocol in addition to the following:
Moderate illness severity •defined as non-ICU level of care at the time of randomization
(not receiving high flow nasal oxygen (HFNO), non-invasive ventilation (NIV), invasive
ventilation (IV), vasopressors or inotropes, or extracorporeal membrane oxygenation (ECMO)
OR Severe illness severity •defined as ICU level of care at the time of randomization
(receiving HFNO, NIV, IV, vasopressors or inotropes, or ECMO)
For moderate illness severity, participants are required to meet one or more of the
following risk criteria:
1. Age ≥ 65 years or
2. ≥2 of the following -
• O2 supplementation > 2 liters per minute
• BMI ≥ 35
• GFR ≤ 60
• History of Type 2 diabetes
• History of heart failure (regardless of ejection fraction)
• D dimer ≥ 2x the site's upper limit of normal (ULN)
• Troponin ≥ 2x the site's ULN
• BNP≥100 pg/mL or NT-proBNP≥300 pg/mL
• CRP ≥50 mg/L
Exclusion Criteria for Arm E
• Exclusion criteria contained in the master protocol, and
• Any condition that, in the opinion of the investigator, precludes the use of
crizanlizumab such as uncontrolled bleeding or severe anemia (hemoglobin<4 g/dL)
• Open label treatment with crizanlizumab within the past three months
Inclusion Criteria for Arm F
Inclusion criteria contained in the master protocol in addition to the following:
Moderate illness severity •defined as non-ICU level of care at the time of randomization
(not receiving high flow nasal oxygen (HFNO), non-invasive ventilation (NIV), invasive
ventilation (IV), vasopressors or inotropes, or extracorporeal membrane oxygenation (ECMO))
OR Severe illness severity •defined as ICU level of care at the time of randomization
(receiving HFNO, NIV, IV, vasopressors or inotropes, or ECMO)
For moderate illness severity, participants are required to meet one or more of the
following risk criteria:
1. Age ≥ 65 years or
2. ≥2 of the following-
• O2 supplementation > 2 liters per minute
• BMI ≥ 35
• GFR ≤ 60
• History of Type 2 diabetes
• History of heart failure (regardless of ejection fraction)
• D dimer ≥ 2x the site's upper limit of normal (ULN)
• Troponin ≥ 2x the site's ULN
• BNP≥100 pg/mL or NT-proBNP≥300 pg/mL
• CRP ≥50 mg/L
Exclusion Criteria for Arm F
In addition to the exclusion criteria noted in the master protocol, arm-specific exclusion
criteria are as follows:
• Known hypersensitivity to any SGLT2 inhibitors
• Type 1 diabetes
• History of diabetic ketoacidosis
• eGFR <20 and/or requirement for renal replacement therapy
• Open label treatment with any SGLT2 inhibitor
• Based on a recommendation from the ACTIV4 DSMB on December 19, 2020, enrollment
of patients requiring ICU level of care into the therapeutic anti-coagulation arm
was stopped due to meeting a futility threshold and a potential for harm for this
sub-group could not be excluded. Enrollment continues for moderately ill
hospitalized COVID-19 patients.
• Based on a recommendation from the ACTIV4 DSMB on June 18, 2021, enrollment of
patients not requiring ICU level of care and randomized to P2Y12 or standard care
was stopped due to meeting a futility threshold. Enrollment continues for
severely ill (ICU level of care) hospitalized COVID-19 patients.
Study of LAU-7b for the Treatment of COVID-19 Disease in Adults (RESOLUTION)
A randomized, double-blind, placebo-controlled Phase 2/3 Study of LAU-7b against confirmed
COVID-19 Disease in hospitalized patients at a higher risk of complications.
1. Subjects must exhibit symptoms (including at least one lower respiratory symptom such
as shortness of breath or dyspnea) of COVID-19 disease at screening and/or since the
start of their hospitalization (may include treated symptoms;
2. Subjects must be 18 years and older, of either gender;
3. Subjects must have at least one of the following factors/co-morbidities:
1. Controlled or uncontrolled diabetes;
2. Pre-existing cardiovascular disease, including hypertension;
3. Pre-existing respiratory disease such as COPD, asthma, emphysema;
4. Active or a former smoker with a 20 pack-years of smoking history;
5. Obesity as depicted by body mass index ≥ 30;
6. Laboratory tests indicative of a higher risk of COVID-19-related complications,
such as troponin >1.5 upper limit of normal, D-dimer >3.0 upper limit of normal
and/or CRP >1.5 upper limit of normal
7. Patient aged 70 years and older who, based on the judgment of the Investigator,
is at a higher risk of developing complications.
4. Subjects must have a documented positive test for the SARS-CoV-2 virus;
5. Subjects must be under observation by, or admitted to a controlled facility or
hospital to receive standard-of-care for COVID-19 disease (care for COVID-19 disease
should be for no more than 72 hours before screening, including any prior stay in
another hospital);
6. Subject's health status must be 3 or 4 on the ordinal scale, and not previously a "5
or a 6";
7. If female, must be either post-menopausal (one year or greater without menses),
surgically sterile, or, for female subjects of child-bearing potential who are capable
of conception, must be: practicing a highly effective method of birth control
(acceptable methods include intrauterine device, complete abstinence, spermicide +
barrier, male partner surgical sterilization, or hormonal contraception) during the
study and through 30 days after the last dose of the study medication. Periodical
abstinence is not classified as an effective method of birth control. A pregnancy test
must be negative at the Screening Visit;
8. Subjects must have the ability to understand and give informed consent, which can be
verbal with a witness, according to local requirements;
9. Subjects deemed capable of adequate compliance including attending scheduled visits
for the duration of the study;
10. Subjects must be able to swallow the study drug capsules.
Exclusion Criteria:
1. Pregnancy or breastfeeding;
2. Health condition deemed to possibly interfere with the study endpoints and/or the
safety of the patients. For example, the following conditions should be considered
contraindicated for participation in the study, but this is not an exhaustive list. In
case of doubt, the Investigator should consult with the sponsor's medical
representative:
1. Presence of inherited retinitis pigmentosa;
2. Presence or history of liver failure (Child-Pugh B or C);
3. Presence or history of stage 4 severe chronic kidney disease or dialysis
requirement;
4. Febrile neutropenia;
5. Presence of end-stage cancer.
3. Known history of a severe allergy or sensitivity to retinoids, or with known allergies
to excipients in the oral capsule formulation proposed to be used in the study;
4. Participation in another drug clinical trial within 30 days (or a minimum of 5
elimination half-lives) prior to screening, except ongoing participation in
non-interventional studies;
5. Calculated creatinine clearance (CrCL, using the Cockroft-Gault equation for example)
<50 ml/min;
6. Presence of total bilirubin >1.5 x ULN (in the absence of demonstrated Gilbert's
syndrome), ALT and/or AST > 2.5 x ULN;
7. Patient expected to be transferred to ICU or die in the next 24 hours.
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
• 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.
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.
• 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
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.
• Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of cancer of the
nasopharynx
• Sites are required to complete Step 1 registration before submitting specimens for EBV
DNA analysis.
• Patients must have detectable pretreatment plasma EBV DNA, determined by the
central lab prior to Step 2 registration (see Section 10.2 for details of
specimen submission).
• For patients who have detectable plasma EBV DNA tested at one of the credentialed
central labs (listed on the EBV DNA Testing Specimen Transmittal form) within 28
days prior to Step 1 registration: that test result can be used for eligibility
without the need for re-testing. To use this test result for eligibility, the
central lab must enter the test result through the pathology portal, and the site
must follow the instructions in Section 5.4.
• Stage II-IVB disease (AJCC, 7th 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 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 required within 28 days prior to registration:
• MRI of the nasopharynx and neck; or CT of the nasopharynx and neck 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.
Please refer to section 6.3.2 for MRI requirement for target delineation.
• To rule out distant metastasis, patients must undergo the following imaging within 28
days prior to registration:
1. a CT scan with contrast of the chest and abdomen (required), and the pelvis
(optional), or a total body PET/CT scan (non-contrast PET/CT is acceptable);
2. 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) and 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. The need to exclude patients with AIDS from this protocol is necessary
because the treatments involved in this protocol may be significantly
immunosuppressive.
• 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
The purpose of the current study is to accelerate the use of a clinically available
therapeutic already FDA-approved for other indications in the setting of pandemic COVID-19
addressing a serious and emergent unmet medical need.
This is a randomized, double-blind study of atovaquone therapy in adult participants
hospitalized with COVID-19. Approximately 60 participants who meet all eligibility criteria
may be randomized in a 2:1 atovaquone/placebo ratio into one of the following treatment
groups:
Treatment Group 1: continued standard of care therapy together with an oral dose of 1500 mg
atovaquone twice daily (administered with a meal or snack) for up to 10 days
Treatment Group 2: continued standard of care therapy together with matching placebo
1. Diagnosis of COVID-19 by positive RT-PCR requiring hospitalization within 72 hours
2. Age ≥18 years old
3. Able to provide informed consent, or (as allowed by IRB), immediate availability of
designated legally authorized representative to provide consent by proxy
4. Anticipated hospitalization for >48 hours
Exclusion Criteria:
1. Participation in any other clinical trial with antiviral activity against COVID-19
2. Breastfeeding women
3. Known hypersensitivity to atovaquone or formulation excipient
4. Active treatment with rifampin
5. HIV patients with AIDS requiring treatment for Pneumocystis jirovecii or Toxoplasma
gondii
6. Not expected to survive for 72 hours. 7) >14 days from symptom onset
Drug: Experimental Group, Drug: Placebo Group
COVID-19, Other
UT Southwestern; Parkland Health & Hospital System
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.
• 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
Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE) (INSPIRE)
The Innovative Support for Patients with SARS COV-2 Infections Registry (INSPIRE) study is a
CDC-funded COVID-19 project to understand the long-term health outcomes in recently tested
adults, both negative and positive, who have suspected COVID symptoms at the time of their
test. Participants will complete short online surveys every 3 months for 18 months, share
information about their health using a secure web-based platform, and are compensated for
their time.
INCLUSION CRITERIA
1. Fluent in English or Spanish;
2. Age 18 and over;
3. Self-reported symptoms suggestive of acute SARSCOV2 infection;
4. Under investigation for SARSCOV2 (defined as a patient who has received any screening
or diagnostic test used to detect the presence of COVID19 including any FDA approved
or authorized molecular or antigen-based assay) within the last 42 days.
EXCLUSION CRITERIA
1. Unable to provide informed consent;
2. Study team unable to confirm result of diagnostic test for SARSCOV2;
3. Does not have access to a hand-held device or computer that would allow for digital
participation in the study;
4. Individuals who are prisoners while participating in the study.
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.
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
An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection
The TARGET-HBV study engages an observational research design to conduct a comprehensive
review of outcomes for patients with CHB infection. The initial phase of the study that
enrolled patients treated with tenofovir alafenamide (TAF) was successfully completed. The
current protocol (Amendment 1) describes the second phase of the study that will engage
research activities for patients being managed for CHB in usual clinical practice in the US
and Canada. The study addresses important clinical questions regarding the management of CHB
by collecting and analyzing data from patients at academic and community medical centers.
TARGET-HBV creates a robust database of real-world data regarding the natural history,
management, and health outcomes related to antiviral treatments used in clinical practice.
Inclusion
1. Male or female patients, age ≥18 years
2. Being managed for chronic hepatitis B (CHB), including patients who have achieved
functional cure and patients with concurrent delta hepatitis
Exclusion
1. Inability to provide written informed consent
2. Known history of Human Immunodeficiency Virus (HIV)
3. History of liver transplantation
Other: All approved therapies for the treatment of Chronic Hepatitis B (CHB)
Liver Diseases, Hepatitis B, Hepatitis
UT Southwestern; Parkland Health & Hospital System