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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