Clinical Trial on Antiviral Drug to Treat COVID-19 Begins

New randomized, controlled NIH supported clinical trial has begun to assess the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with COVID-19.

Remdesivir, antiviral medication developed by Gilead Sciences Inc., previously tested in humans with Ebola infection, has shown promise in animal models for treating MERS and SARS caused by coronaviruses. It may also help treat COVID-19 patients.

The trial has begun at the University of Nebraska Medical Center in Omaha. The first trial participant, an American was repatriated after being quarantined on the Diamond Princess cruise ship that docked in Yokohama, Japan and volunteered to participate in the study.

‘New double blind, randomized clinical trial assess the efficacy of Remdesivir for patients with lab-confirmed SARS-CoV-2 infection with evidence of lung involvement.’
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Clinical trials of remdesivir are also ongoing in China.

Participants in the NIH-sponsored trial must have laboratory-confirmed SARS-CoV-2 infection and evidence of lung involvement, including rattling sounds when breathing (rales) 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.

All potential participants will undergo a baseline physical exam before receiving treatment. Eligible study participants will then be randomly assigned either to the investigational treatment group or the placebo group.

Coronavirus
Coronaviruses infect animals, humans, and birds. Human coronaviruses, such as SARS, MERS, and 2019-nCoV cause respiratory distress and even death. The S protein is the infectious agent of the virus.

The study is double-blind, meaning trial investigators and participants would not know who is receiving remdesivir or placebo. Participants in the investigational treatment group will receive 200 milligrams (mg) of remdesivir intravenously on the first day of enrollment to the study.

They will receive another 100 mg each day for the duration of hospitalization, for up to 10 days total. The placebo group will receive, at an equal volume, a solution that resembles remdesivir but contains only inactive ingredients.

Clinicians will regularly monitor participants and will assign them daily scores based on a predefined scale of clinical outcomes that considers factors such as temperature, blood pressure and use of supplemental oxygen, among others.

Participants also will be asked to provide blood samples and nose and throat swabs approximately every two days. Researchers will test these specimens for SARS-CoV-2.

Initially, investigators will compare participant outcomes on day 15 in both the remdesivir group and the placebo group to see if the investigational drug increased clinical benefit compared to placebo.

Outcomes are scored on a seven-point scale ranging from fully recovered to death. Investigators will reevaluate this scale after reviewing data from the first 100 participant

Source-Medindia