A promising treatment – Remdesivir – is now progressing a clinical trial for COVID19 supported by the National Institutes of Health

Multiple clinical trials are now in progress aimed at developing COVID19 vaccines, repurposing drugs or new treatments running across the US, Canada, Europe and China.  Programmes include large multinational pharma companies such as GSK and Sanofi, mid-sized biotech companies such Gilead and Moderna, and academic organisations, supported by, for example, government funding, the Wellcome Trust, or the Bill and Melinda Gates Fund.  As of writing, there are almost 250 COVID19/coronavirus clinical trials listed at the EMA and/or Clinicaltrials.gov.

 

One of the more promising studies in development from Gilead Sciences Inc., is “Remdesivir”, supported at the NIH evaluating patients at the University of Nebraska Medical Center in Omaha.  The randomized, controlled clinical trial aims to evaluate the safety and efficacy of the investigational antiviral treatment in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19).  Participants in the NIH-sponsored trial must have laboratory-confirmed SARS-CoV-2 infection and evidence of lung involvement, including rattling sounds when breathing with a need for supplemental oxygen or abnormal chest X-rays, or illness requiring mechanical ventilation. Individuals with confirmed infection who have mild, cold-like symptoms or no apparent symptoms will not be included in the study. In accordance with standard clinical research protocols, eligible patients will provide informed consent to participate in the trial.  More information from Clinicaltrials.gov is listed under NCT04280705.

 

The trial regulatory sponsor is the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health and this is the first clinical trial in the United States to evaluate an experimental treatment, the respiratory disease first detected in December 2019 in Wuhan, Hubei Province, China.  According to the NIH, the first trial participant is an American repatriated after being quarantined on the Diamond Princess cruise ship that docked in Yokohama, Japan who volunteered to participate in the study. The study drug is (Remdesivir), a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524.  200 mg of the Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose for the duration of the hospitalization up to a 10 days total course.  The NIAID Director and U.S. Coronavirus Task Force member Anthony S. Fauci, M.D. stated, “We urgently need a safe and effective treatment for COVID-19. Although Remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes. A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”