On May 8, 2020, the U.S. National Institutes of Health (NIH) announced that 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) had begun. The trial is expected to open at approximately 100 U.S. and international sites. Investigators currently anticipate enrolling more than 1,000 participants.

The clinical trial is the next iteration of NIAID’s Adaptive COVID-19 Treatment Trial (ACTT), which began on Feb. 21 to evaluate remdesivir, an investigational broad-spectrum antiviral treatment developed by Gilead Sciences, Inc. That trial closed to enrollment on April 19 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 April 27 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.

Baricitinib, a product licensed to Eli Lilly and Company by Incyte and marketed under the brand name Olumiant, is approved in the U.S. and in more than 65 additional countries as a treatment for adults with moderately to severely active rheumatoid arthritis. Some people with COVID-19 experience acute respiratory distress syndrome (ARDS), in which inflammation of the lungs leads to shortness of breath and rapid breathing. Baricitinib, taken orally, inhibits cytokine signaling in the body that play roles in causing inflammatory responses. The putative benefit of baricitinib for COVID-19 has been described in a case series of critically ill patients who recovered from COVID-19. The combination of remdesivir and baricitinib for COVID-19 has not been evaluated in a large, randomized controlled treatment trial.