On Mar. 25, 2020, physician-scientists at four University of California Health medical centers — UC San Diego Health, UC San Francisco, UC Irvine Health and UC Davis Health — announced they had begun recruiting participants for a Phase II clinical trial to investigate the safety and efficacy of treating adult patients with COVID-19 with remdesivir, an antiviral drug that has shown activity in animal models and human clinical trials of SARS-CoV, MERS-CoV, Ebola, Marburg and other viruses.

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 COVID-19 (SARS-CoV-2) infections.

The multicenter trial will be randomized, double-blind and placebo-controlled, with the capacity to enroll in up to 75 sites globally. The UC 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.

Developed by Gilead Sciences, remdesivir belongs to a class of antiviral drugs that inhibit RNA-dependent RNA polymerase, an enzyme necessary for some RNA viruses like SARS-CoV-2 to replicate. Thus, inhibiting the enzyme may prevent viral replication in infected cells. The most commonly used antiviral drug in this class of drugs is acyclovir, used for the treatment of herpes simplex virus, chickenpox and shingles.

The study will consist of a series of two-arm comparisons between different therapeutic agents and a placebo, with interim monitoring to introduce new arms as needed and to allow for early stoppage if any agents prove ineffective or unsafe.