NIAID Stops COVID-19 Trial Enrollment Over Adverse Events

The National Institute of Allergy and Infectious Diseases (NIAID) has stopped enrolling severely ill COVID-19 patients in a phase 3 trial of Merck’s Rebif (interferon beta-1a) with Gilead Sciences’ remdesivir because of serious adverse events.

An interim review of safety data found more adverse events among patients on high-flow oxygen/non-invasive mechanical ventilation who received Rebif vs. those who did not receive the drug.

There were no concerns among patients who had less severe COVID-19, and the trial will continue to enroll patients on low-flow oxygen and those not requiring supplemental oxygen.

The Adaptive COVID-19 Treatment Trial 3 (ACTT-3), which got under way in August, is evaluating whether the combination treatment could reduce recovery time compared to remdesivir alone. It aimed to enroll 1,000 patients across the U.S. and abroad (DID, Aug. 7).

The ACTT-3 study is the third iteration of the NIAID’s Adaptive COVID-19 Treatment Trial, which is designed to evaluate remdesivir as a treatment for COVID-19. In early September, a separate arm of the study found that remdesivir along with Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib) reduced recovery time in hospitalized COVID-19 patients compared to remdesivir alone (DID, Sept. 15). — Jordan Williams