University Of Alabama At Birmingham

  • CTSA Program Hub
    Center for Clinical and Translational Science
  • This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.

    Whether 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course, can reduce severity of COVID-19 illness and/or improve time to recovery when compared with placebo.
    Target Population
    Inclusion Criteria:

    Admitted to a hospital with symptoms suggestive of COVID-19 infection.
    Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
    Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
    Male or non-pregnant female adult > / = 18 years of age at time of enrollment.
    Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen, as documented by either or the following:

    PCR positive in sample collected < 72 hours prior to randomization; OR
    PCR positive in sample collected >/= 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
    Illness of any duration, and at least one of the following:

    Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
    SpO2 < / = 94% on room air, OR
    Requiring supplemental oxygen, OR
    Requiring mechanical ventilation.
    Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29.
    Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29.
    Exclusion Criteria:

    Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal.
    Estimated glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration).
    Pregnancy or breast feeding.
    Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
    Allergy to any study medication.
    Study Type
    Treatments and Interventions
    Clinicaltrials.gov Status
    Submitted to clinicaltrials.gov
    ClinicalTrials.gov Identifier
    NCT04280705
    Current Study Status
    Recruiting
    Current Study Phase
    Phase 3
    Clinical Trial Network Utilization
    Yes
    Vaccine Trial Evaluation Unit
    Accrual Target Number
    572
    CTSA Support
    No
  • Event
    Working from home on laptop at night
    Date
    -
    Self-Care in the COVID Era
  • Regional Consortia
    SHARe Logo
    Southeast Health Alliance For Research
  • Educational Content
    scholarship
    Statistical Topics for Reproducible Animal Research
    Indiana University
    University Of Alabama At Birmingham
    National Institutes of Health
  • Consortium News
    From left to right: Renee McCoy (MCW), Adam Davidson (UW), Nia Indelicato (UAMS), Aileen Dinkjian (USC), Pam Dillon (VCU), Hardeep Ranu (Harvard), Madeline Gibson (UAB), Margaret Schneider (UCI), Tanya Mathew (OSU), April Bagaporo (UCI)
    The CTSA External Reviewer Exchange Consortium (CEREC): Engagement and Efficacy
  • Event
    CCTS Translational Training Symposium
    Date
    -
    Translational Training Symposium
  • Poster
    CCTS Special  Modules poster v20190907-04

    CCTS Genomic Medicine & Precision Therapeutics

    University Of Alabama At Birmingham
  • Event
    Date
    -
    University of Alabama at Birmingham Aging Symposium
  • Event
    Date
    -
    I-Corps Regional Short Course Returns to CCTS Hub this Summer
  • Opportunity

    I-Corps: bridging biomedical innovation and the market

    Employer/Host
  • Opportunity

    UAB/Children’s of Alabama/School of Health Professions

    Employer/Host
  • Opportunity

    UAB/Children’s pediatric simulation center

    Employer/Host
  • Opportunity

    UAB Pharmacoepidemiology and Economic Research (PEER) Unit

    Employer/Host
  • Opportunity

    Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS)

    Employer/Host
  • Opportunity

    Phase I clinical trials/public-private partnerships

    Employer/Host
  • Opportunity

    Clinical Informatics / medical systems

    Employer/Host
  • Opportunity

    Cochrane Musculoskeletal Review Group

    Employer/Host
  • Opportunity

    Alliance for Innovative Medical Technology (AIMTech)/medical device development (R. Hergenrother, PhD)

    Employer/Host