Clinical Trial to Evaluate Drug Combination of Gilead’s Remdesivir and Eli Lilly’s Baricitinib for COVID-19 Treatment

The National Institutes of Health {(NIH) Bethesda, MD, USA} has begun a randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen of investigational antiviral remdesivir plus the anti-inflammatory drug baricitinib for COVID-19.

The trial is now enrolling hospitalized adults with COVID-19 in the US and is expected to open at approximately 100 US and international sites. The clinical trial is the next iteration of NIAID’s Adaptive COVID-19 Treatment Trial (ACTT), which began in late February to evaluate remdesivir, an investigational broad-spectrum antiviral treatment developed by Gilead Sciences’ (Foster City, CA, USA). In the trial, patients who received remdesivir had a statistically significant shorter time to recovery as compared to patients who received a placebo. 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 (Indianapolis, Ind, USA) by Incyte and marketed under the brand name Olumiant, is approved in the US 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 plays a role in causing inflammatory responses.

In the double-blind study, remdesivir will be administered as one 200-milligram (mg) IV dose followed by a 100-mg once-daily IV dose for the duration of hospitalization up to a 10-day total course of treatment. Baricitinib will be administered as a 4-mg oral dose (or crushed and given through a nasogastric tube, if necessary) for the duration of hospitalization up to a 14-day total course of treatment. Investigators will evaluate whether time to recovery is shorter in the combination arm (baricitinib plus remdesivir), relative to remdesivir alone.

“We now have solid data showing that remdesivir diminishes to a modest degree the time to recovery for people hospitalized with COVID-19,” said NIAID Director Anthony S. Fauci, M.D. “ACTT 2 will examine if adding an anti-inflammatory agent to the remdesivir regimen can provide additional benefit for patients, including improving mortality outcomes.”

Related Links:
National Institutes of Health (NIH)
Gilead Sciences
Eli Lilly and Company