University Of California Davis

  • Consortium News
    KL2 Scholar provides tips on the use of telehealth for pediatric populations
  • Resource
    StudyPages
    UC Davis research teams find added value to online study management tools
  • Consortium News
    UC Davis Researcher Receives the "Translation from Clinical Use into Public Benefit and Policy Award" from the ACTS
  • Consortium News
    Marcus Deloney
    UC Davis Trainee Selected for Presentation at the ACTS
  • Consortium News
    Modeling Clinical Processes to Consent Research Donors of Remnant Biospecimens in an Outpatient Cardiology Clinic
  • 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
  • Consortium News
    Nam Tran
    UC Davis Health named to governor’s Task Force for COVID-19 testing
  • Consortium News
    UC Davis language study
    Five language outcome measures evaluated for intellectual disabilities studies
  • Consortium News
    Rebecca Shields, UC Davis
    Validating NIH Toolbox to help evaluate cognitive processing in people with intellectual disability
  • Consortium News
    COVID Clinical Research
    UC Davis CTSC Clinical Research Center Supports 2 COVID-19 Studies
  • Networks
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    UC BRAID Consortium
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    Journal of Clinical and Translational Science seeks Editorial Board members
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    Journal of Clinical and Translational Science seeks Editorial Board members
  • Educational Content
    CTSpedia
    CTSpedia: A Knowledge Base for Clinical and Translational Research
    University Of California San Francisco
    University Of Rochester
    University Of California Davis
    Vanderbilt University Medical Center
  • Consortium News
    UC BRAID
    UC BRAID Collaborations Work to Impact Health throughout California
  • Consortium News
    Dr. Shaikh
    KL2 Scholar: American Board of Pediatrics Names Dr. Ulfat Shaikh the 2020 PAUL V. MILES FELLOW
  • Event
    HSDD2020
    Date
    -
    Health Science Data Day 2020
  • Consortium News
    ArtRx
    KL2 Scholar: Managing Pain through Art (ArtRx)
  • Poster

    Enhancing Human Health Through Collaboration on Companion Animal Research

    University Of California Davis
  • CTSA Program Hub
    University of California, Davis