First clinical trial to evaluate the safety and efficacy of an antiviral in adults with COVID-19

The SARS-CoV-2 virus, which caused the coronavirus disease 2019 (COVID-19), is the most important health emergency without a specific therapeutic treatment approved by the Food and Drug Administration (FDA). COVID-19 can cause mild to severe respiratory illness.

To date, on March 11st, the number of cases reported by the World Health Organization (WHO) are:

  • Globally 118 322 confirmed (4623 new)
  • China 80 955 confirmed (31 new); 3162 deaths (22 new)
  • Outside of China 37 367 confirmed (4592 new); 1130 deaths (258 new)
  • 58 countries (113 new);
  • Outside China, in particular: Korea 7 775, Italy 10 149 and France 1774

In this scenario, the University of Nebraska Medical Center (UNMC) in Omaha has started a randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with COVID-19. The regulatory sponsor of the trial is the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial has involved people who were repatriated after being quarantined on the Diamond Princess cruise ship and volunteered to participate in the study.

Remdesivir, developed by Gilead Sciences Inc., is an investigational broad-spectrum antiviral treatment. It was previously tested in humans with the Ebola virus disease, and has shown promise in animal models for treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by other coronaviruses.



NIH Clinical trial of Remdesivir to treat COVID-19 begins. National Institutes of Health, U.S. Department of Health & Human Services.