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.
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).
Call 214-648-5005 studyfinder@utsouthwestern.edu
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.
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 SARS-CoV-2 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 1 will be
participants who receive neutralizing monoclonal antibodies (nMAbs) as standard of care
(SOC), estimated to be about 20% of participants. Stratum 2 will be participants who do not
receive nMAbs, estimated to be about 80% of participants.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Mamta Jain
41138
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04910269
STU-2021-0399
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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:
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 IgA deficiency or anti-IgA antibodies.
• Medical conditions for which receipt of a 300 mL volume of IV fluid from study
treatment may pose specific risk to the patient (e.g., decompensated congestive heart
failure).
• 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
Call 214-648-5005 studyfinder@utsouthwestern.edu
Raksha Jain
19733
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT04294043
STU-2021-0279
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Inclusion Criteria:
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
Evaluation of Point-of-Care (EPOC) for COVID-19 ((EPOC))
EPOC is designed to examine the feasibility of conducting two point-of-care (POC) tests the
LumiraDx SARS-CoV-2 Antibody Test and the RightSign COVID-19 IgG/IgM Rapid Test for
SARS-CoV-2 antibodies and compare the reproducibility of these tests to tests run at a
central laboratory on specimens obtained from the same study participants at the same time.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Mamta Jain
41138
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05227404
STU-2022-0468
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Inclusion Criteria:
• Age ≥ 18 years.
• Informed consent by the patient or the patient's legally authorized representative
(LAR) for up to 4 fingersticks for POC testing and a blood draw for stored blood
samples.
• SARS-CoV-2 infection, documented by a nucleic acid test (NAT) or equivalent testing
within 3 days prior to consent OR documented by NAT or equivalent testing more than 3
days prior to consent AND progressive disease suggestive of ongoing SARS-CoV-2
infection per the responsible investigator. (For non-NAT tests, only those deemed with
equivalent specificity to NAT by the protocol team will be allowed. A central list of
allowed non-NAT tests is maintained for TICO and that list will also be used for this
protocol.)
• Duration of symptoms attributable to COVID-19 ≤ 12 days per the responsible
investigator.
• Requiring admission for inpatient hospital acute medical care for clinical
manifestations of COVID-19, per the responsible investigator, and NOT for purely
public health or quarantine purposes.
Exclusion Criteria:
• Prior receipt of SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered
from COVID-19, or SARS-CoV-2 nMAb within 6 months of the blood draws for testing as
part of this protocol.
• Disease severity beyond that of stratum 1 in the TICO trial. This includes the
following conditions:
1. stroke
2. meningitis
3. encephalitis
4. myelitis
5. myocardial infarction
6. myocarditis
7. pericarditis
8. symptomatic congestive heart failure (CHF; New York Heart Association [NYHA]
class III-IV)
9. arterial or deep venous thrombosis or pulmonary embolism
• Current requirement for any of the following:
1. high-flow supplemental oxygen
2. non-invasive ventilation
3. invasive mechanical ventilation
4. extracorporeal membrane oxygenation
5. mechanical circulatory support
6. vasopressor therapy
7. commencement of renal replacement therapy at this admission (i.e., not patients
on chronic renal replacement therapy).
• In the opinion of the responsible investigator, any condition for which, participation
would not be in the best interest of the participant or that could limit protocol
specified assessments.
Diagnostic Test: LumiraDX, Diagnostic Test: RightSign, Diagnostic Test: Case Control
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
Call 214-648-5005 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
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.
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
Call 214-648-5005 studyfinder@utsouthwestern.edu
David Wojciechowski
188709
All
18 Years and over
N/A
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.
HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients
The primary objective of this study is to determine if an HIV-infected deceased kidney donor
(HIVD+) transplant is safe with regards to major transplant-related and HIV-related
complications.
Call 214-648-5005 studyfinder@utsouthwestern.edu
David Wojciechowski
188709
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03500315
STU-2019-0808
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Inclusion Criteria:
• Participant meets the standard criteria for kidney transplant at the local center.
• Participant is able to understand and provide informed consent.
• Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE)
Act Safeguards.
• Documented HIV infection (by any licensed assay, or documented history of detectable
HIV-1 RNA).
• No living donor available.
• Participant is ≥18 years old.
• Opportunistic complications: if prior history of an opportunistic infection, the
participant has received appropriate therapy and has no evidence of active disease.
• Cluster of Differentiation 4 (CD4)+ T-cell: ≥200/µL within 16 weeks of transplant.
• HIV-1 is below 50 copies RNA/mL. Viral blips between 50-400 copies allowed as long as
there are not consecutive measurements >200 copies/mL.
• Participant is willing to comply with all medication related to their transplant and
HIV management.
• For participant with a history of aspergillus colonization or disease, no evidence of
active disease.
• The participant must have, or be willing to start seeing, a primary medical care
provider with expertise in HIV management.
• All participants participating in sexual activity that could lead to pregnancy must
use an FDA approved method of birth control.
• 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.
• 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 or may impact the quality or
interpretation of the data obtained from the study.
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.
Call 214-648-5005 studyfinder@utsouthwestern.edu
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.
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.
Call 214-648-5005 studyfinder@utsouthwestern.edu
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
COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
The purpose of this study is to evaluate the safety, dose-requirements, and exploratory
efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in
children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection
(i.e., COVID-19).
Call 214-648-5005 studyfinder@utsouthwestern.edu
Ayesha Zia
149180
All
up to 18 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04354155
STU-2020-0672
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Inclusion Criteria:
1. Birth to <18 years of age; AND
2. Positive nucleic acid test for SARS-CoV-2 within the past 7 days; AND
3. Hospitalized, <72 hours post-admission; AND
4. One or more signs and/or symptoms of COVID-19 illness within the past 72 hours, as
follows:
1. Cough; OR
2. Fever (oral temperature >100.4°F/38°C); OR
3. Chest pain; OR
4. Shortness of breath; OR
5. Myalgia; OR
6. Acute unexplained loss of smell or taste; OR
7. New/increased supplemental oxygen requirement; OR
8. Acute respiratory failure requiring non-invasive or invasive ventilation; OR
9. Encephalitis.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation
in this study:
1. Receiving therapeutic anticoagulation for treatment of a thromboembolic event
diagnosed within the past 12 weeks; OR
2. Clinical-relevant bleeding (see criteria under Primary Outcome, below) within the past
72 hours; OR
3. Platelet count <50,000/µL within the past 24 hours; OR
4. Prothrombin time (PT) ≥2 seconds above the upper limit of age-appropriate local
reference range within the past 24 hours; OR
5. Activated partial thromboplastin time (aPTT) ≥4 seconds above the upper limit of
age-appropriate local reference range within the past 24 hours; OR
6. Fibrinogen level <75 mg/dL; OR
7. Severe renal impairment, as defined by estimated glomerular filtration rate (eGFR) <31
mL/min/ 1.73 m2, as calculated by the Schwartz formula; OR
8. Parent or legally authorized representative unwilling to provide informed consent for
patient participation.
COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations (SARS)
Background: Allergic reactions have been reported to occur after vaccination with both the
Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine. Allergic reactions range from
mild to severe and include life- threatening anaphylactic reactions, although no deaths have
been reported with either vaccine.
This study is designed with two principal aims:
- To estimate the proportions of systemic allergic reactions to the Pfizer-BioNTech
COVID-19 Vaccine and the Moderna COVID-19 Vaccine in a High-Allergy/Mast Cell Disorder
(HA/MCD) population, and
- If the risk in the HA/MCD is demonstrable, to determine whether the proportions are
higher in the HA/MCD in comparison to a representative population without severe
allergies or mast cell disorders
Call 214-648-5005 studyfinder@utsouthwestern.edu
David Khan
13860
All
5 Years to 17 Years old
Phase 2
This study is also accepting healthy volunteers
NCT04761822
STU-2021-0087
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Inclusion Criteria:
Individuals who meet all of the following criteria are eligible for enrollment as study
participants:
Both groups (e.g., High-Allergy and Mast Cell Disorder (HA/MCD) Group and Comparison
Group):
1. Able to understand and provide informed consent
2. Male or non-pregnant female ≥12 years of age on the date of first study
vaccination/placebo administration (protocol versions 1.0 •4.0) OR male or
non-pregnant female 5-17 years of age on the date of first study vaccination/placebo
administration (protocol version 5.0)
3. Females of childbearing potential must have a negative pregnancy test prior to the
first vaccination and placebo administration, if applicable.
--If a participant becomes pregnant after receiving a placebo dose but prior to
receiving study vaccination, she will be discontinued from the study
4. Females of reproductive potential° and sexually active must agree to use FDA approved
methods of birth control for the duration of the study. These include hormonal
contraceptives, intrauterine device, double barrier contraception (i.e., condom plus
diaphragm), or male partner with documented vasectomy.
• Menopause is defined as at least 12 consecutive months without menses; if in
question, a follicle stimulating hormone of ≥25 U/mL must be documented.
• Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be
documented, as applicable; if documented, women with these conditions are not
required to use additional contraception.
High-Allergy and Mast Cell Disorder (HA/MCD) Group:
Individuals who meet at least one of the following criteria are eligible for enrollment in
the HA/MCD group:
1. History of a severe allergic reaction to food(s), allergen immunotherapy, insect
venom(s), or latex with use of epinephrine within the last 15 years
2. History of an Emergency Department visit with convincing evidence of a systemic
allergic reaction (consistent with CoFAR Grade 3 or higher) to food(s), allergen
immunotherapy, insect venom(s), or latex within the last 15 years
3. History of documented, immediate allergic reactions to 2 or more unrelated drugs
within the last 15 years
4. A convincing clinical history, or a history that is accompanied by a positive skin
test, of an immediate reaction to a drug, vaccine, or latex within the last 15 years
5. History of physician-diagnosed idiopathic anaphylaxis requiring epinephrine or an
Emergency Department visit in the last 15 years
6. History of a physician-diagnosed mast cell disorder (e.g., mastocytosis, mast cell
activation syndrome [MCAS], or hereditary alpha-tryptasemia). MCAS must meet consensus
criteria as defined below:
• Criterion A: Typical clinical signs of severe, recurrent (episodic) systemic Mast
Cell Activation are present (often in form of anaphylaxis)
---Definition of systemic: involving at least 2 organ systems
• Criterion B: Involvement of Mast Cell (MC) is documented by biochemical studies
--- Preferred marker: increase in serum tryptase level from the individual's
baseline to plus 20% + 2 ng/ml
• Criterion C: Response of symptoms to therapy with MC-stabilizing agents, drugs
directed against MC mediator production or drugs blocking mediator release or
effects of MC-derived mediators
• NOTE: All 3 Mast Cell Activation Syndrome (MCAS) criteria (A + B + C) must be
fulfilled to call a condition MCAS.
Comparison Group:
Individuals who meet all of the following criteria are eligible for enrollment in the
comparison group:
1. No history of allergic asthma or atopic dermatitis within the last 10 years
2. No history of chronic spontaneous urticaria, or angioedema
3. No history of allergic reactions to foods or insect venoms
4. No history of allergic reactions to drugs or vaccines
5. No history of anaphylaxis
6. No history of a mast cell disorder (e.g., mastocytosis, mast cell activation syndrome
[MCAS], or hereditary alpha- tryptasemia)
Exclusion Criteria:
Individuals who meet any of these criteria are not eligible for enrollment as study
participants:
1. Inability or unwillingness of a participant and/or parent/legal guardian to give
written informed consent and/or assent, as applicable, or to comply with study
protocol
2. Weight less than 15 kg (33 lbs)
3. Prior receipt of any doses of the Pfizer-BioNTech coronavirus disease 2019 (COVID-19)
Vaccine, Moderna COVID-19 Vaccine, or any other COVID-19 vaccine
4. History of a severe reaction to any component of the Pfizer-BioNTech COVID-19 Vaccine
or Moderna COVID-19 Vaccine
5. History of contact dermatitis with confirmed patch test reaction to Prevalence of
polyethylene glycol (PEG)
6. History of reaction to Doxil®
7. Known exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and
still within the quarantine window
8. Symptoms consistent with acute COVID-19 infection or known COVID-19 infection
(positive Polymerase chain reaction [PCR] or antigen test) and still within the
quarantine window
9. Have an acute illness, including body temperature greater than 100.4 degrees
Fahrenheit, within 14 days of the first study vaccination/placebo administration or 3
days prior to each subsequent vaccination
10. History of autoimmune or other disorders requiring systemic immune modulators
11. History of acute urticaria within 28 days of randomization
12. Pregnant
13. Have received any vaccines within 14 days of the first study vaccination/placebo
administration or plan to receive other vaccines during the study period
14. Had any allergen immunotherapy administration within 24 hours prior to
vaccination/placebo administration or plan to receive within 24 hours after
vaccination/placebo administration
15. Have received a biologic therapy within 6 months of randomization
16. Use of systemic steroids for any reason within 28 days of randomization
17. Use of Zileuton® within 14 days of randomization
18. Use of any monoclonal antibody agent for treatment or prevention of COVID-19 within 3
months of randomization
19. Coronary artery disease, peripheral or cerebral vascular disease, unstable angina, or
cardiac arrhythmia, other than supraventricular tachycardia (SVT)
20. Medically unstable hypertension
21. Current use of beta-blockers, angiotensin-converting enzyme (ACE) inhibitors,
monoamine oxidase (MAO) inhibitors, tricyclic anti-depressants or other agents that
could interfere with the treatment of anaphylaxis, in the opinion of the investigator
22. Unstable asthma within 3 months of randomization or symptomatic asthma on the day of
vaccination, as assessed by the site investigator
23. Have past or current medical problems or findings from physical exam or laboratory
testing not listed above, which in the opinion of the investigator, may pose
additional risks from participation in the study or which may interfere with the
ability to comply with study requirements --This includes individuals with underlying
conditions or other medications that, in the opinion of the investigator, may increase
risk in the event of an anaphylactic reaction or lead to complications following
administration of epinephrine
Biological: Moderna COVID-19 Vaccine, Biological: Pfizer-BioNTech COVID-19 Vaccine, Biological: Placebo
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
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.
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
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
Call 214-648-5005 studyfinder@utsouthwestern.edu
Mamta Jain
41138
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04456153
STU-2020-0707
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Inclusion Criteria:
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
Drug studies often look at the effect one or two drugs have on a medical condition, and
involve one company. There is currently an urgent need for one study to efficiently test
multiple drugs from more than one company, in people who have tested positive for COVID-19
but who do not currently need hospitalization. This could help prevent disease progression to
more serious symptoms and complications, and spread of COVID-19 in the community.
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in
outpatients. In Phase II, participants in the study will be treated with either a study drug
or with placebo. In protocol version 7.0, participants in Phase III of the study will be
treated with either a study drug or active comparator drug. Participants assigned to the
bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study
drug administration, followed by limited follow-up through 24 weeks in phase II and in phase
III. All other investigational agents and their corresponding placebo arms will involve 28
days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and
phase III. Additional study visits may be required, depending on the agent.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Mamta Jain
41138
All
18 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT04518410
STU-2020-1147
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Inclusion Criteria:
• Signed informed consent.
• Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a
molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g.
oropharyngeal, nasopharyngeal (NP), or nasal swab, or saliva) collected ≤240 hours (10
days) prior to study entry. Laboratory-confirmed SARS-CoV-2 infection outside the US
must be conducted at a DAIDS-approved laboratory.
• Able to begin study treatment no later than 7 days from self-reported onset of
COVID-19 related symptom(s) or measured fever, where the first day of symptoms is
considered symptom day 0 and defined by the self-reported date of first reported
sign/symptom from the following list:
• subjective fever or feeling feverish
• cough
• shortness of breath or difficulty breathing at rest or with activity
• sore throat
• body pain or muscle pain/aches
• fatigue
• headache
• chills
• nasal obstruction or congestion
• nasal discharge
• loss of taste or smell
• nausea or vomiting
• diarrhea
• temperature > 38°C (100.4°F)
• One or more of the following signs/symptoms within 24 hours of participating in the
study:
• subjective fever or feeling feverish
• cough
• shortness of breath or difficulty breathing at rest or with activity
• sore throat
• body pain or muscle pain/aches
• fatigue
• headache
• chills
• nasal obstruction or congestion
• nasal discharge
• loss of taste or smell
• nausea or vomiting
• diarrhea
• temperature > 38°C (100.4°F)
• Oxygen levels of ≥92% obtained at rest (adjusted as needed for altitude) by study
staff within 24 hours of study entry. For a potential participant who regularly
receives chronic supplementary oxygen for an underlying lung condition, their oxygen
saturation should be measured while on their standard home oxygen supplementation
level.
• Participant must agree not to participate in another clinical trial for the treatment
of COVID-19 or SARS-CoV-2 during the study period until hospitalization or 28 days
after the start of the study, whichever occurs first.
• Meet the protocol definition of being at "higher" risk of progression to
hospitalization or death (BRII-196/BRII-198).
• In Phase III, meeting the protocol definition of being at "higher" risk of progression
to hospitalization or death (SNG001, SAB-185, BMS 986414+BMS 986413)
• For participants of reproductive potential, negative serum or urine pregnancy test
within 48 hours prior to study entry by any clinic or laboratory that has a CLIA
certification or its equivalent, or by a point of care (POC)/CLIA-waived test. Note:
Participants not of reproductive potential are eligible without requiring the use of a
contraceptive method (BRII-196/BRII-198. AZD7442 [IV], AZD7442 [IM], SNG001, Camostat,
SAB-185, BMS 986414+BMS 986413).
• Participants that engage in sexual activity that may lead to pregnancy in their
partner must agree to either remain abstinent or use male contraceptives. They are
strongly advised to inform their non-pregnant sexual partners of reproductive
potential to use effective contraceptives for 24 weeks after investigational product
is administered. Participants with pregnant partners should use condoms during vaginal
intercourse through 24 weeks after investigational agent administration. Participants
should refrain from sperm donation for 24 weeks after investigational agent
administration (BRII-196/BRII-198, AZD7442 [IV], AZD7442 [IM], SAB-185).
• Participants that engage in sexual activity that may lead to pregnancy in their
partner must agree to either remain abstinent or use male contraceptives for 30 days
after investigational agent administration. They are also strongly advised to inform
their non-pregnant sexual partners of reproductive potential to sue effective
contraceptives for 30 days after investigational agent is administered to the
participant. Participants with pregnant partners should use condoms during vaginal
intercourse through 30 days after last dose of investigational agent administration.
Participants should refrain from sperm donation for 30 days after investigational
agent administration (SNG001).
• Participants that engage in sexual activity that may lead to pregnancy in their
partner must agree to either remain abstinent or use male contraceptives. They are
also strongly advised to inform their non-regnant sexual partners of reproductive
potential to use effective contraceptives from study entry through 90 days after study
treatment. Participants with pregnant partners should use condoms during vaginal
intercourse from study entry through 90 days after the last dose of the study
treatment. Participants should refrain from sperm donation from study entry through 90
days after the last dose of study treatment (Camostat).
• If participating in sexual activity that could lead to pregnancy, participants who are
of reproductive potential must agree to use effective contraception for 24 weeks after
investigational agent is administered. This would include oral contraceptives,
implanted contraceptives, implanted contraceptives, intrauterine devices, and barrier
methods.
• If participating in sexual activity that could lead to pregnancy, participants who are
of reproductive potential must agree to use highly effective contraception for 24
weeks after investigational agent is administered (AZD7442 [IV], AZD7442 [IM],
SAB-185).
• If participating in sexual activity that could lead to pregnancy, participants who are
of reproductive potential must agree to use effective contraception for 30 days after
investigational agent is administered (SNG001).
• If participating in sexual activity that could lead to pregnancy, participants who are
of reproductive potential must agree to use effective contraception for 90 days after
the last dose of treatment (Camostat).
• If participating in sexual activity that could lead to pregnancy, participants who are
of reproductive potential must agree to use highly effective contraception for at
least 48 weeks after the investigational agent is administered (BMS 986414+BMS
986413).
Exclusion Criteria:
• History of or current hospitalization for COVID-19.
• For the current SARS-CoV-2 infection, any positive SARS-CoV-2 nucleic acid or antigen
tests from any respiratory tract specimen collected > 240 hours prior to study entry.
• Current need for hospitalization or immediate medical attention.
• Use of any prohibited medication listed in the protocol and/or use of systemic or
inhaled steroids for the purpose of COVID-19 treatment (new or increased dose from
chronic baseline) within 30 days prior to study.
• Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2
treatment or prophylaxis at any time prior to study entry.
• Receipt of other investigational treatments for SARS-CoV-2 any time before
participating in the study (not including drugs approved and taken for other
conditions/diseases or COVID-19 vaccines).
• Known allergy/sensitivity or hypersensitivity to study drug or placebo.
• Any condition requiring surgery up to 7 days before participating in the study, or
that is considered life threatening up to 30 days before participating in the study.
• Currently pregnant or breastfeeding (BRII-196/BRII-198, AZD7442 [IV], AZD7442 [IM],
SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
• In phase II, meeting the protocol definition of being at "higher" risk of progression
to hospitalization or death (AZD7442 [IV], AZD7442 [IM], SNG001, Camostat, SAB-185,
BMS 986414+BMS 986413).
• Inflammatory skin conditions that compromise the safety of intramuscular (IM)
injections, or other overlying skin conditions or tattoos that would preclude the
assessment of injection site reactions, per the discretion of the investigator
(AZD7442 [IM]).
• Inflammatory skin conditions that compromise the safety of subcutaneous (SC)
injections, or other overlying skin conditions or tattoos that would preclude the
assessment of infection site reactions, per the discretion of the investigator (BMS
986414+BMS 986413).
• History of coagulopathy which, in the opinion of the investigator, would preclude IM
injection, or use of oral or injectable anticoagulants (protocol provides more
information on prohibited medications) (AZD7442 [IM]).
• Use of or need for chronic supplemental oxygen (SNG001).
• Known severe liver disease prior to enrollment (defined as ALT or AST > 5 times upper
limit of normal or end stage liver disease with Child-Pugh Class C or
Child-Pugh-Turcotte score ≥ 10) (Camostat).
• Known severe kidney disease prior to enrollment (defined as estimated glomerular
filtration rate (eGFR) <30 ml/min/1.73m² or on renal-replacement therapy such as
peritoneal dialysis or hemodialysis (Camostat)
Other investigational drug protocol-defined inclusion/exclusion criteria may apply.
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.
• All participants 12 to <18 years old must have documented positive CMV serostatus (CMV
IgG seropositive) for the recipient (R+) within 90 days prior to enrollment.
Participants from birth to <12 years old must have documented positive CMV serostatus
(CMV IgG seropositive) for the recipient (R+) within 90 days prior to enrollment
and/or the donor (D+); the donor serostatus should be documented within 1 year prior
to enrollment.
• 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.
• For participants 2 <12 years old their weight should be at least 10 kg; for
participants from birth to <2 years old their weight should be at least 2.5 kg and
less than or equal to 15 kg at the time of enrollment.
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 a) on renal replacement therapy (eg, hemodialysis, peritoneal dialysis) OR b) 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.
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
Call 214-648-5005 studyfinder@utsouthwestern.edu
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
Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant (Prevent)
This is a Phase 2 study to evaluate posoleucel (ALVR105, formerly Viralym-M); an allogeneic,
off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus,
cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.
Key Inclusion Criteria
• ≥1 year of age at the day of screening visit.
• Either no evidence of viral infection or viremia, or asymptomatic, viral infection
with 3 or fewer viruses of interest at time of screening
• Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated
clinical engraftment
• Meet one or more of the following criteria at the time of randomization:
• Related (sibling) donor with at least one mismatch at one of these HLA-gene loci:
HLA-A, -B or -DR
• Haploidentical donor
• Unrelated donor with at least one mismatch at one of these HLA-gene loci: HLA-A,
-B, -C, or -DR
• Use of umbilical cord blood as stem cell source
• Ex vivo graft manipulation resulting in T cell depletion
• Lymphocyte Count <180/mm3 and/or cluster of differentiation 4 (CD4) Count <50/mm3
Key
Exclusion Criteria:
• History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months
prior to randomization
• Evidence of active Grade >2 acute GVHD
• Presence of non-minor uncontrolled or progressive bacterial, viral or fungal
infections
• Known history or current (suspected) diagnosis of CRS requiring treatment associated
with the administration of peptides, proteins, and/or antibodies
• Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent
dose >0.5 mg/kg/day) within 24 hours prior to dosing
• Relapse of primary malignancy other than minimal residual disease
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Biological: Posoleucel (ALVR105)
Cytomegalovirus Infections, Adenovirus Infection, Brain and Nervous System, Leukemia, Other, Hodgkins Lymphoma, Leukemia, Not Otherwise Specified, Lymphoid Leukemia, Myeloid and Monocytic Leukemia, Non-Hodgkins Lymphoma, Other Hematopoietic, BK Virus Infection, JC Virus Infection, Epstein-Barr Virus Infections, Human Herpes Virus-6 Infection
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.
Call 214-648-5005 studyfinder@utsouthwestern.edu
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
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.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Ahamed Idris
58880
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT04610515
STU-2020-1352
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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.
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.
Call 214-648-5005 studyfinder@utsouthwestern.edu
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.
Blood Purification With Seraph 100 Microbind Affinity Blood Filter for Treatment of Severe COVID19 Observational Study (PURIFY-OBS-1)
This is a multi-center, observational study that will enroll 1) patients with severe COVID-19
who have agreed to undergo therapy with Seraph® 100 under the existing EUA; 2) patients
(medical record data) that have been previously treated with the Seraph® 100 after the date
of the EUA approval (17 April 2020), but before the date that the study is approved at the
study site, and 3) a convenience sample of patients (medical record data) in a historical
control group who were admitted to the ICU at participating sites with severe COVID-19
infection, meeting the EUA treatment criteria, but not treated with Seraph® 100 up to the
time the PURIFY-OBS protocol is approved at the site
Call 214-648-5005 studyfinder@utsouthwestern.edu
Benjamin Levi
198600
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT04606498
STU-2020-0998
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Inclusion Criteria:
Prospective Seraph® 100
1. Subject must be 18 years of age
2. Per the FDA Approve EUA:
Subject must have confirmed COVID-19 infection and be admitted to the ICU with confirmed or
imminent respiratory failure and any one of the following conditions:
1. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
2. Severe disease, defined as:
1. Dyspnea,
2. Respiratory frequency ≥ 30/min,
3. Blood oxygen saturation ≤ 93%,
4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300,
and/or
5. Lung infiltrates > 50% within 24 to 48 hours; or
3. Life-threatening disease, defined as:
1. Respiratory failure,
2. Septic shock, and/or
3. Multiple organ dysfunction or failure. 2. Prospective study patients (or their
Legally Authorized Representative (LAR)) provides informed consent. Patients or
their legally authorized representative will be consented in their main language
if they are not fluent in English.
3. Prospective study patient is willing to complete all study visits as required by
the protocol 4. For Military Treatment Facility (MTF) enrollment only •must be DEERS
eligible for care at the MTF
Retrospective Seraph® 100
1. Subject must be 18 years of age
2. Per the FDA Approve EUA:
Subject must have confirmed COVID-19 infection and be admitted to the ICU with
confirmed or imminent respiratory failure and any one of the following conditions:
1. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS);
or
2. Severe disease, defined as:
1. Dyspnea,
2. Respiratory frequency ≥ 30/min,
3. Blood oxygen saturation ≤ 93%,
4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio
<300, and/or
5. Lung infiltrates > 50% within 24 to 48 hours; or
3. Life-threatening disease, defined as:
1. Respiratory failure,
2. Septic shock, and/or
3. Multiple organ dysfunction or failure.
3. Treated with Seraph® 100 from 17 April 2020 (date of EUA approval) to the date of
study approval at the study site.
Historical Control
1. Subject must be 18 years of age
2. Per the FDA Approve EUA:
Subject must have confirmed COVID-19 infection and be admitted to the ICU with
confirmed or imminent respiratory failure and any one of the following conditions:
1. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS);
or
2. Severe disease, defined as:
1. Dyspnea
2. Respiratory frequency ≥ 30/min,
3. Blood oxygen saturation ≤ 93%,
4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio
<300, and/or
5. Lung infiltrates > 50% within 24 to 48 hours; or
3. Life-threatening disease, defined as:
1. Respiratory failure,
2. Septic shock, and/or
3. Multiple organ dysfunction or failure.
3. Hospitalized from 20 January 2020 to the date of study approval at the study site.
Exclusion Criteria:
Prospective
1. Unwilling to provide informed consent
2. Unable to provide informed consent and no LAR available to provide permission
Retrospective No specific exclusion criteria. However, patients treated with Seraph® 100
prior to approval of the study at a site and who remains admitted to the hospital at the
time the study is approved, will be given the opportunity to participate in the study by
signing consent for their health data to be collected (and not biospecimens).
Historical Controls:
Patients who remain admitted to the hospital at the time that the study is approved at the
study site will be excluded.
Community Network-driven COVID-19 Testing of Vulnerable Populations in the Central US (C3)
This C3 project, Community network-driven COVID-19 testing of vulnerable populations in the
Central US, will implement and evaluate a COVID-19 testing approach that combines an
evidence-based Social Network Testing Strategy (SNS) with community developed COVID-19 public
health messages (SNS+). C3 will engage two disenfranchised populations across rural and urban
sites in states across the Central US (TX, LA, AR, IN, IL). C3 leverages NIDA's Justice
Community Opioid Innovation Network (JCOIN), the PIs' extensive community located COVID-19
testing programs, and a network of established community partnerships. The collaborative
community-academic partnerships, research and engagement infrastructure, and team's
leadership across JCOIN will ensure that C3 can rapidly recruit, enroll and test most
disenfranchised community members, (n=2400) and through this process, accelerate any
forthcoming COVID-19 public health prevention interventions. C3 focuses on two communities
most impacted by COVID-19: 1) Criminal justice involved (CJI) - non-incarcerated people with
previous history of arrest/jail/prison, probation/parole and drug-court attendance; and 2)
Low-income Latinx - community members at 250% or below Federal Poverty Level. Both of these
diverse populations, and the overlap between them, have some of the highest rates of COVID-19
infection and death in the United States. Messaging that affirms individual agency and
corrects misinformation, combined with accessible and acceptable testing, is required to
accelerate COVID-19 prevention for these populations
Call 214-648-5005 studyfinder@utsouthwestern.edu
Kavita Bhavan
109489
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT04743908
STU-2020-1342
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Inclusion Criteria:
• Index community members will be:
1. 18 years or older;
2. spend majority of their time in the metropolitan area or county where recruited;
3. have access to a phone for 21-day follow-up call; and
4. primary communication in English or Spanish (based on site chart above) AND at
least one of the following: (i) CJI in the previous five years (operationalized
as any jail, prison, arrest, parole (completed), probation, drug court during
this timeframe); (ii) lower-income Latinx (operationalized as at or below 250% of
FPL).
Social network referrals will be:
1. linked to the index as a "friend, family, coworker or someone you spend time with
on a regular basis";
2. visit within two weeks of index visit;
3. 18 years or older;
4. spend the majority of their time in the metropolitan area or county where
recruited;
5. have access to a phone for 21-day follow-up call; and
6. primary communication in English or Spanish.
Exclusion Criteria:
1. inability to provide informed consent; and
2. active COVID-19 symptoms per CDC. Participants with COVID-19 symptoms will be
referred for free testing at existing partners for each of the study sites.
3. currently on parole
Other: Social Network Strategy + COVID-19 messaging
Covid19
Criminal Justice Involved, Latinx, Social Network Strategy
A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of
antithrombotic strategies in patients with COVID-19 following hospital discharge
Call 214-648-5005 studyfinder@utsouthwestern.edu
Sonja Stutzman
120434
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04650087
STU-2021-0233
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Inclusion Criteria:
• • Age ≥ 18 years
• PCR-positive COVID-19 infection
• Hospitalized for two or more days
Exclusion Criteria:
• Pre-existing indication for anticoagulation (e.g., pulmonary embolism or deep vein
thrombosis; atrial fibrillation; mechanical cardiac valve)
• Contraindication to antithrombotic therapy (e.g., known bleeding within the last 30
days requiring emergency room presentation or hospitalization; major surgery within 14
days; ischemic stroke, intracranial bleed or neurosurgery within 3 months.
• Platelet count < 50,000/mcL
• Hemoglobin <8 gm/dL
• Renal insufficiency (eGFR < 30 mL/min/1.73 m2)
• Pregnancy
• Prison inmate
• Life expectancy less than 90 days
• Unwilling or unable to provide informed consent/unwilling or unable to complete the
study protocol
• Dual antiplatelet therapy that cannot be discontinued
• Concomitant need for strong inducers/inhibitors of p-gp or CYP3A4
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.
Call 214-648-5005 studyfinder@utsouthwestern.edu
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
Respiratory Virus Hospitalization Study (FLU 003 Plus)
Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus,
this observational study was initiated to estimate rates of morbidity and mortality and to
examine predictors of severity among participants with 2009 H1N1 infection. In 2011, as
surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza
A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes
and influenza B viruses. The current version of the protocol (released in August 2013)
further broadens the scope of this observational study. With the recognition that novel
respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory
Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health
importance, the objectives of this protocol have been expanded.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Mamta Jain
41138
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT01056185
STU-2019-1761
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Inclusion Criteria:
• Be ≥ 18 years of age
• Have been admitted to hospital
• Have a signed informed consent by participant or surrogate/representative
• Have a local diagnosis (confirmed or suspected) of influenza, or of a targeted
non-influenza viral respiratory infection*, resulting in (or extending a previous)
hospitalization
• A list of targeted non-influenza respiratory viruses is maintained on the INSIGHT
website.
Exclusion Criteria:
• Current imprisonment, or compulsory detention (involuntary incarceration) for treat of
a psychiatric or physical illness.