Coronavirus on Trial.

• Author: Routh, Jennifer
• Position: Medicine & Health - Remdesivir for Covid-19

"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."

A RANDOMIZED, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at the University of Nebraska Medical Center (UNMC) in Omaha. The trial regulatory sponsor 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 U.S. to evaluate an experimental treatment for COVTD-19, the respiratory disease first detected in December 2019 in Wuhan, Hubei Province, China.

The first trial participant is an American who was repatriated after being quarantined on the Diamond Princess cruise ship that docked in Yokohama, Japan, and volunteered to participate in the study. The study can be adapted to evaluate additional investigative treatments and to enroll participants at other sites in the U.S. and worldwide.

There are no specific therapeutics approved by the Food and Drug Administration to treat people with COVID-19, the disease caused by the newly emergent SARS-CoV-2 virus (formerly known as 2019nCoV). Infection can cause mild to severe respiratory illness, and symptoms can include fever, cough, and shortness of breath.

Remdesivir is an investigational broad-spectrum antiviral treatment. It previously was tested in humans with 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.

"We urgently need a safe and effective treatment for COVID-19. Although remdesivir has been administered to some patients with COVTD-19, we do not have solid data to indicate it can improve clinical outcomes," says Anthony S. Fauci, director of NIAID and member of the U.S. Coronavirus Task Force. "A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients."

Clinical trials of remdesivir also are ongoing in China. NIAID developed the current study taking those designs into account, and in accordance with...