Doctors regularly monitor participants and assign them daily scores based on a pre-defined clinical outcome scale that takes into account factors such as temperature, blood pressure and use of supplemental oxygen. Participants are asked to provide blood samples and nose and throat samples approximately every two days. Researchers test these samples for SARS-CoV-2. First, the researchers will compare the results of participants on day 15 in both the remdesivir group and the placebo group to see if the investigational drug increased the clinical benefit compared to the placebo. Results are scored on a seven-step scale ranging from complete recovery to death. After reviewing the data from the first 100 participants, the researchers will re-evaluate the scale. 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 recommends stopping when there is clear and substantial evidence of a therapeutic difference between drug and placebo. Andre Kalil, M.D., professor of internal medicine at UNMC and infectious disease physician at the Nebraska Institute of Medicine, is the director of the trial at UNMC. Thirteen individuals selected by the US State Department from the cruise ship Diamond Princess were transferred to a National Quarantine Unit, located at the Training, Simulation and Quarantine Center on the UNMC/Nebraska campus in Omaha on February 17, 2020. These passengers were located near an area of significant spread of COVID-19 and were sent to the unit for continued quarantine and possibly further care. The CDC has since reported that 11 people at the UNMC unit showed confirmed SARS-CoV-2 infection. The UNMC National Quarantine Unit is supported by the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the Department of Health and Human Services. It has a 20-bed capacity if a higher level of care is needed and is adjacent to the Nebraska Biocontrol Unit. Participants in the clinical trial are cared for in the intensive care unit. “We thank the individuals for their participation in this trial, and we are pleased that the NIH has selected UNMC/Nebraska Medicine as the site for this important work,” said Dr. Kalil. Our expertise in treating highly infectious disease – as well as our ability to conduct leading-edge clinical trials – ensures that this trial is carried out in the best possible way. For more information, visit ClinicalTrials.gov and search ID NCT04280705. NIAID conducts research—at NIH, across the United States, and around the world—to investigate the causes of infectious and immune-mediated diseases, and to develop better ways to prevent, diagnose, and treat these diseases. News releases, fact sheets, and other NIAID-related materials are available on the NIAID website. About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, consists of 27 institutes and centers and is part of the US Departments of Health and Human Services. NIH is the lead federal agency that conducts and supports basic, clinical, and translational medical research, investigating the causes, treatments, and cures of common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity – not approved for every use anywhere in the world. Remdesivir has shown in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are also coronaviruses and are structurally similar to COVID-19. Limited clinical data on remdesivir in MERS and SARS suggest that remdesivir may have potential activity against COVID-19. It’s an experimental drug that has only been used in a small number of patients with COVID-19 so far, so Gilead doesn’t have a good understanding of how effective the drug will be to warrant widespread use at this time.
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