NIH clinical trial of remdesivir to treat
COVID-19 begins
Dr KK Aggarwal
President CMAAO, HCFI and Past national
President IMA
A randomized, controlled NIH supported clinical trial
to evaluate the safety and efficacy of the investigational antiviral remdesivir
in hospitalized adults diagnosed with COVID-19 has begun at the University of
Nebraska Medical Center in Omaha.
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.
Remdesivir, developed by Gilead Sciences Inc., is an
investigational broad-spectrum antiviral treatment. It was previously tested in
humans with Ebola virus disease and has shown promise in animal models for
treating MERS and SARS, which are caused by other coronaviruses.
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.
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 participants.
