A randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen of the investigational antiviral remdesivir plus the anti-inflammatory drug baricitinib for coronavirus disease 2019 (COVID-19) has begun. The trial is now enrolling hospitalized adults with COVID-19 in the United States. The trial is expected to open at approximately 100 U.S. and international sites. Investigators currently anticipate enrolling more than 1,000 participants.
National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring the trial. The clinical trial is the next iteration of NIAID’s Adaptive COVID-19 Treatment Trial (ACTT), which began on 21 February to evaluate remdesivir, an investigational broad-spectrum antiviral treatment developed by Gilead Sciences, Inc. That trial closed to enrollment on
19 April after recruiting 1,063 participants at 47 U.S. and 21 international sites.
An independent data and safety monitoring board (DSMB) overseeing the trial met on 27 April and shared their preliminary analysis with the study sponsor, NIAID. Their analysis showed that patients who received remdesivir had a statistically significant shorter time to recovery compared to patients who received placebo. More detailed information about the trial results, including more comprehensive data, will be available in a forthcoming report. In this next trial with baricitinib, called ACTT 2, all participants will receive remdesivir or remdesivir with baricitinib.