Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19.
Journal
Nature communications
ISSN: 2041-1723
Titre abrégé: Nat Commun
Pays: England
ID NLM: 101528555
Informations de publication
Date de publication:
22 08 2022
22 08 2022
Historique:
received:
04
05
2022
accepted:
04
08
2022
entrez:
22
8
2022
pubmed:
23
8
2022
medline:
25
8
2022
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 35995785
doi: 10.1038/s41467-022-32551-2
pii: 10.1038/s41467-022-32551-2
pmc: PMC9395368
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Antibodies, Neutralizing
0
Antibodies, Viral
0
Antiviral Agents
0
RNA, Viral
0
bamlanivimab
45I6OFJ8QH
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
4931Subventions
Organisme : NIAID NIH HHS
ID : UM1 AI069424
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069432
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068634
Pays : United States
Organisme : NIAID NIH HHS
ID : R01 AI028433
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI068636
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069463
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068636
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069494
Pays : United States
Organisme : NIH HHS
ID : R01 OD011095
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069423
Pays : United States
Commentaires et corrections
Type : ErratumIn
Informations de copyright
© 2022. The Author(s).
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