{"id":"brii-196","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Hypersensitivity reactions"},{"rate":null,"effect":"Injection site reactions"}]},"_chembl":{"chemblId":"CHEMBL4650382","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BRII-196 is a fully human monoclonal antibody designed to target the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein. By binding to this critical viral epitope, it prevents the virus from attaching to and entering human cells, thereby neutralizing viral infectivity. The antibody was developed through a collaboration between NIAID and Brii Biosciences for treatment and prevention of COVID-19.","oneSentence":"BRII-196 is a monoclonal antibody that binds to the spike protein of SARS-CoV-2 to neutralize the virus and prevent infection.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:42:21.145Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"COVID-19 treatment in adults and adolescents"},{"name":"COVID-19 post-exposure prophylaxis"}]},"trialDetails":[{"nctId":"NCT04518410","phase":"PHASE2, PHASE3","title":"ACTIV-2: A Study for Outpatients With COVID-19","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2020-08-19","conditions":"Coronavirus, Covid19","enrollment":4044},{"nctId":"NCT05780424","phase":"PHASE3","title":"BRII-196/BRII-198 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2020-12-16","conditions":"COVID-19","enrollment":353},{"nctId":"NCT04501978","phase":"PHASE3","title":"ACTIV-3: Therapeutics for Inpatients With COVID-19","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2020-08-04","conditions":"Covid19","enrollment":2753},{"nctId":"NCT04952402","phase":"PHASE4","title":"SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2021-07-09","conditions":"Covid19, SARS-CoV2 Infection","enrollment":43},{"nctId":"NCT04691180","phase":"PHASE1","title":"A Phase 1 Study of Human Monoclonal Antibodies, BRII-196 and BRII-198","status":"COMPLETED","sponsor":"Brii Biosciences Limited","startDate":"2021-01-05","conditions":"COVID-19","enrollment":12},{"nctId":"NCT04770467","phase":"PHASE2","title":"A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19","status":"WITHDRAWN","sponsor":"Brii Biosciences, Inc.","startDate":"2021-02","conditions":"COVID-19","enrollment":""},{"nctId":"NCT04787211","phase":"PHASE2","title":"A Study of Human Monoclonal Antibodies, BRII-196 and BRII-198","status":"COMPLETED","sponsor":"Brii Biosciences Limited","startDate":"2021-06-20","conditions":"COVID-19","enrollment":48},{"nctId":"NCT04479631","phase":"PHASE1","title":"Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-196","status":"COMPLETED","sponsor":"Brii Biosciences Limited","startDate":"2020-07-12","conditions":"COVID-19","enrollment":16}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"BRII-196","genericName":"BRII-196","companyName":"National Institute of Allergy and Infectious Diseases (NIAID)","companyId":"national-institute-of-allergy-and-infectious-diseases-niaid","modality":"Biologic","firstApprovalDate":"","aiSummary":"BRII-196 is a monoclonal antibody that binds to the spike protein of SARS-CoV-2 to neutralize the virus and prevent infection. Used for COVID-19 treatment in adults and adolescents, COVID-19 post-exposure prophylaxis.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}