{"doi":"10.17615/30ns-3210","title":"Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19","abstract":"Anti-SARS-CoV-2 monoclonal antibodies are mainstay COVID-19 therapeutics. Safety, antiviral, and clinical efficacy of bamlanivimab were evaluated in the randomized controlled trial ACTIV-2/A5401. Non-hospitalized adults were randomized 1:1 within 10 days of COVID-19 symptoms to bamlanivimab or blinded-placebo in two dose-cohorts (7000 mg, n = 94; 700 mg, n = 223). No differences in bamlanivimab vs placebo were observed in the primary outcomes: proportion with undetectable nasopharyngeal SARS-CoV-2 RNA at days 3, 7, 14, 21, and 28 (risk ratio = 0.82-1.05 for 7000 mg [p(overall) = 0.88] and 0.81-1.21 for 700 mg [p(overall) = 0.49]), time to symptom improvement (median 21 vs 18.5 days [p = 0.97], 7000 mg; 24 vs 20.5 days [p = 0.08], 700 mg), or grade 3+ adverse events. However, bamlanivimab was associated with lower day 3 nasopharyngeal viral levels and faster reductions in inflammatory markers and viral decay by modeling. This study provides evidence of faster reductions in nasopharyngeal SARS-CoV-2 RNA levels but not shorter symptom durations in non-hospitalized adults with early variants of SARS-CoV-2.","journal":"UNC Libraries","year":2022,"id":311124,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9626,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":549307,"name":"J. Ritz","orcid":null,"position":1,"is_corresponding":false},{"id":1006541,"name":"C. Moser","orcid":null,"position":2,"is_corresponding":false},{"id":1007386,"name":"K. Price","orcid":null,"position":3,"is_corresponding":false},{"id":1007387,"name":"M. Giganti","orcid":null,"position":4,"is_corresponding":false},{"id":1007388,"name":"A.S. Perelson","orcid":null,"position":5,"is_corresponding":false},{"id":155692,"name":"Y. Li","orcid":null,"position":6,"is_corresponding":false},{"id":974537,"name":"J.S. Currier","orcid":null,"position":7,"is_corresponding":false},{"id":1006551,"name":"A. Nirula","orcid":null,"position":8,"is_corresponding":false},{"id":1006544,"name":"P. Klekotka","orcid":null,"position":9,"is_corresponding":false},{"id":529449,"name":"J.Z. Li","orcid":null,"position":10,"is_corresponding":false},{"id":1006538,"name":"K.W. Chew","orcid":null,"position":11,"is_corresponding":false},{"id":1006539,"name":"M.C. Choudhary","orcid":null,"position":12,"is_corresponding":false},{"id":591508,"name":"D.A. Wohl","orcid":null,"position":13,"is_corresponding":false},{"id":1007389,"name":"R.M. Ribeiro","orcid":null,"position":14,"is_corresponding":false},{"id":549390,"name":"J.J. Eron","orcid":null,"position":15,"is_corresponding":false},{"id":1007390,"name":"W. Fischer","orcid":null,"position":16,"is_corresponding":false},{"id":611483,"name":"R. Deo","orcid":null,"position":17,"is_corresponding":false},{"id":1006550,"name":"ACTIV- A Study Team","orcid":null,"position":18,"is_corresponding":false},{"id":974536,"name":"A.C. Javan","orcid":null,"position":19,"is_corresponding":false},{"id":1006542,"name":"E.S. Daar","orcid":null,"position":20,"is_corresponding":false},{"id":1007391,"name":"C. Malvestutto","orcid":null,"position":21,"is_corresponding":false},{"id":974543,"name":"C.V. Fletcher","orcid":null,"position":22,"is_corresponding":false},{"id":1006554,"name":"R.W. Coombs","orcid":null,"position":23,"is_corresponding":false},{"id":1007392,"name":"V. Bala","orcid":null,"position":24,"is_corresponding":false},{"id":1006546,"name":"D.M. Smith","orcid":null,"position":25,"is_corresponding":false},{"id":974538,"name":"M.D. Hughes","orcid":null,"position":0,"is_corresponding":true}],"reference_count":0,"raw_metadata":null,"created_at":"2026-07-19T00:33:24.451129Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}