Clinical trial to evaluate safety, efficacy of remdesivir in adults with COVID-19 begins

Clinical trial to evaluate safety, efficacy of remdesivir in adults with COVID-19 begins

Simple blood test measures the body's immune response to improve ovarian cancer diagnosis All potential participants will undergo a baseline physical exam before receiving treatment. Eligible study participants will then be randomly assigned either to the investigational treatment group or the placebo group. The study is double-blind, meaning trial investigators and participants would not know who is receiving remdesivir or placebo. Participants in the investigational treatment group will receive 200 milligrams (mg) of remdesivir intravenously on the first day of enrollment to the study. They will receive another 100 mg each day for the duration of hospitalization, for up to 10 days total. The placebo group will receive, at an equal volume, a solution that resembles remdesivir but contains only inactive ingredients. Clinicians will regularly monitor participants and will assign them daily scores based on a predefined scale of clinical outcomes that considers factors such as temperature, blood pressure and use of supplemental oxygen, among others. Participants also will be asked to provide blood samples and nose and throat swabs approximately every two days. Researchers will test these specimens for SARS-CoV-2. Initially, investigators will compare participant outcomes on day 15 in both the remdesivir group and the placebo group to see if the investigational drug increased clinical benefit compared to placebo. Outcomes are scored on a seven-point scale ranging from fully recovered to death. Investigators will reevaluate this scale after reviewing data from the first 100 participants. An independent data and safety monitoring board (DSMB) will monitor ongoing results to ensure patient well-being and safety as well as study integrity. The DSMB will recommend the study be halted if there is clear and substantial evidence of a treatment difference between drug and placebo. Andre Kalil, M.D., professor of internal medicine at UNMC and an infectious diseases physician at Nebraska Medicine, is leading the trial at UNMC. Thirteen people repatriated by the U.S. State Department from the Diamond Princess cruise ship were transported to the National Quarantine Unit, located within the Training, Simulation and Quarantine Center on the UNMC/Nebraska Medicine campus in Omaha on February 17, 2020. The passengers were in a close setting where there had been significant spread of COVID-19 and were sent to the unit for continued isolation and possibly further care. The CDC has since reported that 11 people in the UNMC unit have confirmed SARS-CoV-2 infection. UNMC's National Quarantine Unit is supported by the office of the Assistant Secretary for Preparedness and Response (ASPR) at the Department of Health and Human Services. It has a 20-bed capacity and is in close proximity to the Nebraska Biocontainment Unit, should a higher level of care be needed. Clinical trial participants are cared for in the biocontainment unit. "We thank the individuals for their participation in this trial, and we are pleased that the NIH has chosen UNMC/Nebraska Medicine as the site for this important work," said Dr. Kalil. "Our expertise in treating highly infectious disease--as well as our capacity to conduct leading-edge clinical trials--will ensure that this trial is carried out in the most effective manner possible." Source:



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