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  • This study aims to understand how the body’s immune system responds to COVID-19, including if and when a person could be re-infected with the virus and whether some people have pre-existing immunity. The study will recruit up to 100 COVID-19 positive individuals across all age groups from the Rochester community and follow them for 90 days. The researchers will collect samples that will enable them to isolate and study the virus, and measure immune response to the infection. Specifically, it will track the production of antibodies that seek out and flag the virus for destruction by immune cells. Once produced in sufficient quantity, these antibodies and other cells generated by the immune system provide protection from re-infection. These cells are also activated after vaccination. However, as is the case with other viral infections such as the flu, it is speculated that immunity to COVID-19 will weaken over time.

    This research will seek to answer several important questions, including the durability of immunity from the virus once a person has been infected and recovered, whether the virus is mutating, whether previous exposure to other seasonal coronaviruses provides a degree of protection from COVID-19, and how long potential vaccines could provide immunity from the virus.
    Target Population
    The study population will be drawn from individuals 6 months to 80 years old with acute influenza-like respiratory illness seen at clinics, emergency rooms or hospitals at the University of Rochester. Additionally, close family members living in the same household of persons with known and confirmed COVID19 infection will be enrolled. Subjects with COVID19 infections will have mild to moderate disease.
    Primary Investigator
    Angela
    Branche
    Study Type
    Treatments and Interventions
    Clinicaltrials.gov Status
    Pre-clinicaltrials.gov
    Current Study Status
    Recruiting
    Current Study Phase
    Not a Clinical Trial
    Clinical Trial Network Utilization
    Yes
    Centers for Excellence for Influenza Research and Surveillance
    Accrual Target Number
    100
    CTSA Support
    No
    Locations
  • 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
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    Advancing Regulatory Science, Precision Medicine and Translational Network Science through the University of Rochester Clinical and Translational Science Institute Optional Cores

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    2019 Fall Forum on Regulatory Science to Advance Precision Medicine
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