The study will evaluate the safety and effectiveness of novel therapeutic agents, the first which is the experimental antiviral drug remdesivir.
The experimental treatment will initially be compared to a placebo, according to the news release. Researchers will interim monitor results to determine if the treatment is effective, safe, or if other treatments should be added. If a particular therapy shows positive results, then this treatment will become the standard for comparisons with new experimental treatments.
Trial participants will receive placebo or remdesivir intravenously for up to 10 days total, according to the news release. Clinicians will monitor participants regularly and assign them daily scores based on a scale of clinical outcomes that considers factors such as temperature, blood pressure and use of supplemental oxygen, along with others. Participants will be asked to provide blood samples and throat swabs, after which researchers will test the specimens for the SARS-CoV-2 virus and for the body’s response to the infection. Outcomes are scored on an eight-point scale, ranging from fully recovered to death. After 100 participants, investigators will reevaluate the scale.
On day 15, investigators will compare participant outcomes in both the remdesivir group and placebo group to determine if the drug produced clinical benefits.
Participants in the trial must have laboratory-confirmed SARS-CoV-2 infection, with evidence of pneumonia. Those individuals with confirmed infection who have mild, cold-like symptoms or no apparent symptoms will not be included.
Data from the trial, sponsored by the National Institute of Allergy and Infectious Diseases, will be monitored by an independent Data and Safety Monitoring Board to ensure patient well-being and safety as well as study integrity.