![]() ![]() 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. (Foster City, California), and subcutaneous interferon beta-1a, a drug approved for multiple sclerosis manufactured by Merck KGaA, Darmstadt, Germany. 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. The DSMB will continue monitoring the trial to ensure participant well-being and safety, as well as study integrity.ĪCTT-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. Therefore, the study will continue to enroll hospitalized patients on low-flow oxygen and those not requiring supplemental oxygen. The DSMB noted no safety concerns among study participants with less severe COVID-19. 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 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.
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