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Los Angeles, Calif. - The AIDS Clinical Trials Group (ACTG), the largest global HIV research network, today announced that the Camostat treatment group of the COVID-19 outpatient treatment study, ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies Trial, will not move to phase 3. ACTIV-2 includes both phase 2 and phase 3 evaluations of multiple investigational agents for treating early COVID-19 in a single trial. For information about the trial, please visit the study website.
Camostat, provided by Sagent Pharmaceuticals (a Nichi-Iko Group Company), is an orally administered protease inhibitor that was dosed as 200 mg every six hours for seven days. The Camostat arm of ACTIV-2 completed phase 2 enrollment with 224 participants on April 26, 2021. When the Therapeutic and Prevention Data and Safety Monitoring Board (DSMB) met on June 14, 2021 to review the data and determine whether Camostat would advance to phase 3, they determined that while there were no safety concerns, the phase 2 data failed to meet the criteria for graduation (which is based on demonstrating early changes in viral shedding or improvement in symptoms). Participants enrolled in phase 2 in the Camostat treatment group will continue to be followed per the ACTIV-2 protocol.