A randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults with coronavirus disease 2019 (COVID-19) has been initiated at the University of Nebraska Medical Center (UNMC) in Omaha. Sponsoring the regulation is the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. This is the first clinical trial in the United States to evaluate an experimental test for COVID-19, the respiratory disease first discovered in December 2019 in Wuhan, Hubei Province, China.
The first participant in the trial is an American who volunteered to participate in the study after being quarantined on the Diamond Princess cruise ship docked in Yokohama, Japan. This study could be useful for evaluating further treatment interventions and participant participation in other regions of the United States and around the world.
There is no specific treatment approved by the US Food and Drug Administration (FDA) to treat people with COVID-19, the disease caused by the newly emerging SARS-CoV-2 virus (formerly known as 2019-nCoV). Infection can cause mild to severe respiratory illness, and symptoms can include fever, cough, and shortness of breath. As of February 24, the World Health Organization (WHO) has confirmed 77,262 confirmed cases of COVID-19 and 2,595 deaths in China, and 2,069 confirmed cases of COVID-19 and 23 cases in 29 other countries. According to the Centers for Disease Control and Prevention (CDC), fourteen confirmed cases of COVID-19 have been reported in the United States and another 39 among people who have returned to the United States.
Remdesivir, developed by Gilead Science Inc. , is a broad-spectrum antiviral treatment. It has already been tested in humans with Ebola virus disease and has shown promise in animal models for the treatment of Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by other coronaviruses. Anthony S. Fauci, M.D. says we urgently need a safe and effective treatment for COVID-19. Although remdesivir has been prescribed for some patients with COVID-19, we do not have strong data to show that it can improve clinical outcomes. A randomized and placebo-controlled clinical trial as the gold standard can determine whether experimental treatment can benefit patients or not. Remdesivir clinical trials are also ongoing in China. NIAID prepared its recent review with these plans in mind and in accordance with the recommendations made by the WHO regarding the development of a therapeutic trial for patients with COVID-19.
Participants in NIH-sponsored trials must have confirmed SARS-CoV-2 infection and have evidence of lung involvement, including rales with the need for supplemental oxygen or an abnormal chest X-ray, or Disease requiring mechanical ventilation. Individuals with confirmed infection who have mild symptoms, such as a cold, or no outward symptoms will not be included in the study. According to standard clinical research protocols, eligible patients provide informed consent to participate in the trial. All potential participants undergo a physical examination prior to treatment. Eligible study participants are then randomly assigned to the research treatment group or the placebo group. The study is double-blind, meaning the trial researchers and the participants do not know who will receive remdesivir or a placebo. Participants in the research intervention group will receive 200 milligrams (mg) of remdesivir intravenously on the first day of study enrollment. They receive another 100 mg per day for the duration of hospitalization, up to 10 days in total. The placebo group, with an equal volume, will receive a solution similar to Remdesivir but only containing the inactive ingredients.
This post is written by Farshadboy000