NIAID begins clinical trial to evaluate safety and efficacy of remdesivir and baricitinib on COVID-19

Remdesivir has been shown to shorten the recovery time for patients suffering from COVID-19, and as a result, the National Institute of Allergy and Infectious Diseases (NIAID) has begun a clinical trial to see how it fairs when paired with the anti-inflammatory baricitinib.

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

The latest test, which will enroll more than 1,000 participants at approximately 100 U.S. and international sites, is the next step of NIAID’s ongoing Adaptive COVID-19 Treatment Trial (ACTT). ACTT began to evaluate remdesivir back in February, starting a trial that recruited 1,063 participants and was overseen by an independent data and safety monitoring board. That board met on April 27 and informed NIAID that patients who received the drug had a statistically significant shorter time to recovery when compared to those given placebos.

A public report of that trial is still forthcoming.

This next trial, named ACTT 2, will see all patients dosed with either remdesivir alone or remdesivir paired with baricitinib. Gilead Sciences, Inc. created remdesivir, and Eli Lilly and Company licensed baricitinib. It is currently used as an arthritis treatment for adults in more than 65 countries, including the U.S. Given that some COVID-19 patients experience inflammation of the lungs, scientists have seen signs of baricitinib’s value when taken orally. What they have not yet seen is how well either drug pair in a controlled test.

That test will be double-blind, with neither investigators nor participants knowing who receives which treatment regimen. To be involved, patients must have a proven SARS-CoV-2 infection and demonstrate lung issues. Those with only mild symptoms will not be included. During the study, investigators will evaluate whether recovery time for the combined effort is shorter than using remdesivir on its own and compare patient outcomes. Recovery tracking will continue until day 29 of the study.