BULLETIN—NIAID Stops Enrollment of Severely Ill COVID-19 Participants in Clinical Trial of Investigational Treatments

ACTT-3 Study Will Continue for Hospitalized Participants with Less Severe Illness

September 29, 2020

The Adaptive COVID-19 Treatment Trial 3 (ACTT-3), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will no longer enroll hospitalized participants with severe COVID-19 requiring high-flow oxygen, and will not begin to enroll patients requiring non-invasive or invasive mechanical ventilation. This action is being taken after an interim review of safety data by the study’s Data and Safety Monitoring Board (DSMB) found an imbalance of serious adverse events among patients on high-flow oxygen/non-invasive mechanical ventilation who received interferon beta-1a versus those who did not receive interferon beta-1a. The DSMB noted no safety concerns among study participants with less severe COVID-19. Therefore, the study will continue to enroll hospitalized patients on low-flow oxygen and those not requiring supplemental oxygen. The DSMB will continue monitoring the trial to ensure participant well-being and safety, as well as study integrity.

ACTT-3, which began August 5, is the third iteration of a randomized, controlled adaptive trial, designed to test therapeutics for people who are hospitalized with COVID-19. The study was designed to evaluate the safety and efficacy of a combination of remdesivir, an investigational broad-spectrum antiviral developed by Gilead Sciences, Inc. (Foster City, California), and subcutaneous interferon beta-1a, a drug approved for multiple sclerosis manufactured by Merck KGaA, Darmstadt, Germany. Prior data from laboratory studies, observational studies, as well as two small randomized controlled trials, suggested that interferon beta-1a may benefit patients with COVID-19. However, before ACTT-3, this combination of remdesivir and interferon beta-1a had not yet been tested in a large, randomized controlled clinical trial.

ACTT-3 study investigators will enroll approximately 1,000 hospitalized adults with COVID-19 in up to 100 hospitals across the United States and internationally. Upon enrollment into the study, participants are randomized to receive remdesivir and either a subcutaneous injection of interferon beta-1a or a placebo injection. Researchers are evaluating whether participants’ time to recovery is shorter in the combination therapy group relative to the remdesivir-only group. At the time of the September 4 DSMB interim review of the ACTT-3 data, 266 participants were enrolled in the study. 
 

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