US begins trial of remdesivir to treat patients with COVID-19
An American who was quarantined aboard a cruise ship docked in Japan is the first participant in an NIH-sponsored U.S. trial that will evaluate an investigational antiviral for the treatment of COVID-19.
The randomized, controlled trial to evaluate the safety and efficacy of remdesivir (Gilead Sciences) is being conducted at the University of Nebraska Medical Center, which has one of the country’s few dedicated biocontainment units.
There are no approved therapeutics to treat COVID-19, the disease caused by the novel coronavirus at the center of a global outbreak that originated in China, which has begun its own trial evaluating remdesivir.
“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,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in a statement.
Remdesivir was part of a trial of four investigational Ebola virus treatments conducted during the ongoing outbreak in the Democratic Republic of the Congo. Testing continued without remdesivir, and another study drug after preliminary findings showed they were not as effective as the other two drugs.
More than a dozen people were transported from the Diamond Princess cruise ship in Yokohama, Japan — where there was an outbreak of COVID-19 — to the medical campus in Nebraska for evaluation. According to the CDC, 11 of them have tested positive for the novel coronavirus.
The NIH said participants in the new trial will have to have lab-confirmed COVID-19 and “evidence of lung involvement.”
There also are no vaccines against the novel coronavirus, but the biotechnology company Moderna announced that it shipped doses of an investigational vaccine (mRNA-1273) to the NIAID for a planned phase 1 study to test its effectiveness against the virus in humans. – by Gerard Gallagher
Disclosure: Fauci reports no relevant financial disclosures.