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ACTG announces Camostat will not advance to phase 3 in outpatient treatment study for COVID-19


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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 ....

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ACTG announces the addition of two monoclonal antibodies to ACTIV-2 outpatient treatment study for COVID-19


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Los Angeles, Calif. - The AIDS Clinical Trials Group (ACTG), the largest global HIV research network, today announced the addition of two monoclonal antibodies, BMS-986414 and BMS-986413, to the COVID-19 outpatient treatment study, ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies Trial. BMS-986414 and BMS-986413 will be administered as subcutaneous injections (shots) given at one visit. 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 enrolling in the trial, please visit the study website.
Given that prevention and treatment will continue to be an important part of ending the COVID-19 pandemic, it is key that we identify and develop a variety of treatment options, said ACTG Chair Judith Currier, M.D., M.Sc., University of California, Los Angeles (UCLA). ACTIV-2 is studying a number of different therapeutic approaches, including infusions, ....

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