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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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Sagent Pharmaceuticals Announces Start of NIAID-Sponsored Study Investigating COVID-19 Treatments in Outpatients

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SCHAUMBURG, Ill., Feb. 12, 2021 /PRNewswire/ Sagent Pharmaceuticals, a Nichi-Iko Group Company, announced today that Camostat mesilate (Camostat), is one of four therapies being added to the existing ACTIV-2 Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID), which was launched by the National Institutes of Health (NIH) and the AIDS Clinical Trials Group (ACTG) in May 2020.
ACTG was tasked with leading a Master Adaptive protocol under the Accelerating COVID-19 Therapeutic Interventions and Vaccine (ACTIV) partnership by Operation Warp Speed (OWS), the U.S. government s multi-agency effort to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The ACTIV-2 trial will continue to evaluate monoclonal antibodies and other small molecules for outpatient COVID treatment. Camostat is the first orally administered agent to be included in the outp ....

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