Researchers at four University of California Health medical centers — including UC San Diego Health — have begun recruiting participants for a clinical trial to investigate the safety and efficacy of treating adult COVID-19 patients with an antiviral drug that has shown some success against other viruses.
The other medical centers, UC San Francisco, UC Irvine Health and UC Davis Health, will test participants with the drug remdesivir. It has shown activity in animal models and human clinical trials of SARS, MERS, Ebola, Marburg and other viruses.
Constance Benson, one of the main researchers on the trial from the UC San Diego School of Medicine, says the drug works by targeting an enzyme that helps the virus replicate.
"An antiviral drug acts to either prevent disease or to treat disease by inhibiting the ability of a virus to replicate and spread or by killing the virus," wrote Benson in an email to KPBS. She adds that a vaccine is different because it works by stimulating the body's immune response to a virus.
"Both approaches are part of a long-term solution. Treatment of people with an effective antiviral drug prevents death or complications from the disease and can clear the virus from the system so that people are no longer infectious or able to transmit to someone else. A vaccine prevents people from getting infected or getting active disease so that they do not become sick and they are not able to transmit infection to other people," wrote Benson.
Benson said she believes the study is likely to fill quickly given the numbers of people in hospitals. She said although the sponsor has indicated the trial will run until April 2023, this date is flexible. An expected 440 people will participate.
"There are interim analyses built into the study at defined intervals so that if there is a positive (or negative) effect seen earlier, the study may be stopped earlier," she wrote.
Remdesivir is not approved by the U.S. Food and Drug Administration for treatment of any infection, but is undergoing clinical trials for treatment of multiple viral diseases, including SARS-CoV-2, the virus that causes coronavirus infections.
The multi-location trial will be randomized, double-blind and placebo-controlled, with the capacity to enroll in up to 75 sites globally. The University of California trial will begin with a small cohort of participants. All must be hospitalized patients with diagnosed COVID-19. All must be patients of UC San Diego Health or other participating UC Health systems.
"Due to the evolving, fluid nature of this research and what we're learning daily about the virus and about improving treatment, the trial is designed to be adaptive, to shift investigation to the most promising avenues," said Benson.
The antiviral drug has been tested in human clinical trials for Ebola, but was found to be only be somewhat successful.
"Experience with the drug in humans is limited. Adverse effects directly attributed to the drug in these limited studies included headache, nausea and elevations of liver tests," wrote Benson.
"With this type of adaptive study design, if remdesivir proves to be safe and active, the clinical trial may be rapidly adapted to remove the requirement for a placebo arm and add a treatment arm that includes other promising antiviral or other investigational drug to compare with the activity of remdesivir," she said.
The trial is sponsored by the National Institute of Allergy and Infectious Disease, part of the National Institutes of Health.
