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Thursday, 27 February 2020

Coronavirus: US begins trial of Gilead's remdesivir in Covid-19 patients


A clinical trial to evaluate the safety and efficacy of the experimental antiviral Remdesivir in hospitalized adults diagnosed with COVID-19, has started at the University of Nebraska Medical Center (UNMC). The trial director is the National Institute of Allergies and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH). It is the first clinical trial in the United States to evaluate an experimental treatment for COVID-19.

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The first participant in the trial is an American who was repatriated after being quarantined on the cruise ship Diamond Princess , which docked in Yokohama, Japan, and volunteered to participate in the study. The research can be adapted to assess additional investigative treatments and to enroll participants at other sites in the United States and around the world.

The need to develop a rapid treatment for COVID-19

There is no specific therapeutic treatment approved by the Food and Drug Administration (FDA) to treat people with COVID-19. The infection can cause mild to severe respiratory illness, and symptoms may include fever, cough, and shortness of breath. As of February 24, the World Health Organization (WHO) had reported 77,262 confirmed cases of COVID-19 and 2,595 deaths in China, as well as 2,069 cases and 23 deaths in 29 other countries.



According to the Centers for Disease Control and Prevention (CDC), 14 confirmed cases of COVID-19 have been reported in the United States and another 39 cases among people repatriated to the United States.

Remdesivir, developed by Gilead Sciences Inc., is an experimental broad-spectrum antiviral treatment. It has already been tested in humans against the Ebola virus and has shown promise in animal models for the treatment of Middle Eastern Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). Clinical trials of remdesivir are also underway in China.

Remdesivir: a double-blind human clinical trial

All potential participants will undergo a basic physical exam before receiving treatment. Eligible study participants will then be randomly assigned to either the experimental treatment group or the placebo group. The study is double-blind, which means that trial investigators and participants do not know who is receiving Remdesivir or a placebo.

Chemical structure of the broad-spectrum antiviral remdesivir. Credit: Gilead

Participants in the experimental treatment group will receive 200 milligrams (mg) of intravenous remdesivir on the first day of study enrollment. They will receive another 100 mg per day for the duration of hospitalization, for a maximum of 10 days. The placebo group will receive, at equal volume, a solution that resembles remdesivir but contains only inactive ingredients.

Clinicians will regularly monitor participants and assign them daily scores based on a predefined scale of clinical outcomes, which takes into account factors such as temperature, blood pressure and the use of supplemental oxygen, among other things. Participants will also be asked to provide blood samples and swabs from the nose and throat approximately every two days. Researchers will test these specimens for SARS-CoV-2.



Initially, the investigators will compare the results of participants on day 15 in the remdesivir group and the placebo group to see if the investigational drug increased clinical benefit compared to placebo. Results are scored on a seven-point scale from full recovery to death. Investigators will reassess this scale after examining the data from the first 100 participants.

Source (NIH)

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