drugset
drugset / Trial / NCT04518410

ACTIV-2: A Study for Outpatients With COVID-19

NCT04518410 ↗

Phase 2/3 Completed 4044 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · collabAstraZeneca · collabBrii Biosciences Limited · collabBristol-Myers Squibb · collabEli Lilly and Company · collabSAb Biotherapeutics, Inc. · collabSagent Pharmaceuticals Inc. · collabSynairgen Research Ltd. · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community. This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.

Timeline

Start
2020-08-19
Primary completion
2022-04-07
Completion
2023-06-20

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject AMUBARVIMAB Monoclonal antibody 1000 mg Intravenous
Subject Bamlanivimab Monoclonal antibody 700 mg Intravenous
Subject Bamlanivimab Monoclonal antibody 7000 mg Intravenous
Subject CREXAVIBART Protein / enzyme biologic 200 mg Subcutaneous
Subject Camostat Small molecule 200 mg Oral
Subject Interferon beta-1a Protein / enzyme biologic 1.3 ml Inhaled
Subject OGALVIBART Protein / enzyme biologic 200 mg Subcutaneous
Subject ROMLUSEVIMAB Monoclonal antibody 1000 mg Intravenous
Subject SAB-185 Protein / enzyme biologic 3840 iu/kg Intravenous
Subject SAB-185 Protein / enzyme biologic 10240 iu/kg Intravenous
Comparator casirivimab Monoclonal antibody 600 mg Intravenous
Subject cilgavimab Monoclonal antibody 150 mg Intravenous
Subject cilgavimab Monoclonal antibody 300 mg Intravenous
Comparator imdevimab Monoclonal antibody 600 mg Intravenous
Subject tixagevimab Monoclonal antibody 150 mg Intravenous
Subject tixagevimab Monoclonal antibody 300 mg Intravenous

Indications

COVID-19