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All Studies   Meta Analysis    Recent:   

Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19

Chew et al., Nature Communications, doi:10.1038/s41467-022-32551-2, ACTIV-2/A5401, NCT04427501
Aug 2022  
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Hospitalization 25% Improvement Relative Risk Hospitalization, 7000mg.. 52% Hospitalization, 700mg, d.. -1% Time to symptom improv.. -14% primary Time to symptom im.. (b) -17% primary Progression, 7000mg -1% Progression, 700mg 2% Viral load, 7000mg, day 3 26% Viral load, 700mg, day 3 35% Bamlanivimab/e..  ACTIV-2/A5401  LATE TREATMENT  RCT Is late treatment with bamlanivimab/etesevimab beneficial for COVID-19? RCT 317 patients in the USA (August - November 2020) Improved viral clearance with bamlanivimab/etesevimab (p=0.002) c19early.org Chew et al., Nature Communications, Aug 2022 Favorsbamlanivimab/e.. Favorscontrol 0 0.5 1 1.5 2+
20th treatment shown to reduce risk in May 2021
 
*, now with p = 0.00036 from 21 studies, recognized in 7 countries. Efficacy is variant dependent.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 75 treatments. c19early.org
RCT 317 outpatients in the USA showing faster viral load and inflammatory biomarker decline, but no significant differences in clinical outcomes.
Efficacy is highly variant dependent. In Vitro research suggests a lack of efficacy for omicron1-5.
risk of hospitalization, 25.5% lower, RR 0.75, p = 0.60, treatment 6 of 159 (3.8%), control 8 of 158 (5.1%), NNT 78, combined.
risk of hospitalization, 52.1% lower, RR 0.48, p = 0.43, treatment 2 of 48 (4.2%), control 4 of 46 (8.7%), NNT 22, 7000mg, day 28.
risk of hospitalization, 0.9% higher, RR 1.01, p = 1.00, treatment 4 of 111 (3.6%), control 4 of 112 (3.6%), 700mg, day 28.
relative time to symptom improvement, 13.5% higher, relative time 1.14, p = 0.97, treatment 48, control 46, 7000mg, primary outcome.
relative time to symptom improvement, 17.1% higher, relative time 1.17, p = 0.08, treatment 111, control 112, 700mg, primary outcome.
risk of progression, 0.6% higher, RR 1.01, p = 1.00, treatment 42 of 48 (87.5%), control 40 of 46 (87.0%), at least one symptom more severe than baseline, 7000mg.
risk of progression, 2.0% lower, RR 0.98, p = 0.62, treatment 102 of 111 (91.9%), control 105 of 112 (93.8%), NNT 54, at least one symptom more severe than baseline, 700mg.
viral load, 25.6% lower, relative load 0.74, p = 0.002, treatment 48, control 46, 7000mg, day 3.
viral load, 35.3% lower, relative load 0.65, p = 0.07, treatment 111, control 112, 700mg, day 3.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Chew et al., 22 Aug 2022, Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, 26 authors, study period 19 August, 2020 - 15 November, 2020, average treatment delay 6.0 days, trial NCT04427501 (history) (ACTIV-2/A5401). Contact: kchew@mednet.ucla.edu.
This PaperBamlaniv../e..All
Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19
Kara W Chew, Carlee Moser, Eric S Daar, David A Wohl, Jonathan Z Li, Robert W Coombs, Justin Ritz, Mark Giganti, Arzhang Cyrus Javan, Yijia Li, Manish C Choudhary, Rinki Deo, Carlos Malvestutto, Paul Klekotka, Karen Price, Ajay Nirula, William Fischer, Veenu Bala, Ruy M Ribeiro, Alan S Perelson, Courtney V Fletcher, Joseph J Eron, Judith S Currier, Michael D Hughes, Davey M Smith
Nature Communications, doi:10.1038/s41467-022-32551-2
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. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Coronavirus disease 2019 (COVID-19), continues to exert an enormous global public health and economic toll, and in the U.S. case-fatality rates exceed estimates for the 1918 influenza pandemic 1 . Anti-SARS-CoV-2 monoclonal antibody (mAb)-based therapies have shown sufficient clinical efficacy to receive emergency
Author contributions Competing interests Additional information Supplementary information The online version contains supplementary material available at https://doi.org/10.1038/s41467-022-32551-2.
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Development of the RealTime SARS-CoV-2 quantitative ' 'Laboratory Developed Test and correlation with viral culture as a ' 'measure of infectivity. J. Clin. Virol. 143, 104945 (2021).', 'journal-title': 'J. Clin. Virol.'}, { 'key': '32551_CR23', 'unstructured': 'Abbott Molecular Inc. Abbott RealTime SARS-CoV-2 Assay Emergency Use ' 'Authorization (EUA) Package Insert, Abbott. 2021.'}, { 'key': '32551_CR24', 'doi-asserted-by': 'publisher', 'first-page': '104474', 'DOI': '10.1016/j.jcv.2020.104474', 'volume': '129', 'author': 'E Degli-Angeli', 'year': '2020', 'unstructured': 'Degli-Angeli, E. et al. Validation and verification of the Abbott ' 'RealTime SARS-CoV-2 assay analytical and clinical performance. J. Clin. ' 'Virol. 129, 104474 (2020).', 'journal-title': 'J. Clin. Virol.'}, { 'key': '32551_CR25', 'doi-asserted-by': 'publisher', 'first-page': '1275', 'DOI': '10.1093/cid/ciab643', 'volume': '74', 'author': 'CM North', 'year': '2022', 'unstructured': 'North, C. M. et al. Determining the incidence of asymptomatic SARS-CoV-2 ' 'among early recipients of COVID-19 vaccines (DISCOVER-COVID-19): A ' 'prospective cohort study of healthcare workers before, during and after ' 'vaccination. Clin. Infect. Dis. 74, 1275–1278 (2022).', 'journal-title': 'Clin. Infect. Dis.'}, { 'key': '32551_CR26', 'doi-asserted-by': 'publisher', 'first-page': 'e0261045', 'DOI': '10.1371/journal.pone.0261045', 'volume': '17', 'author': 'PL Tzou', 'year': '2022', 'unstructured': 'Tzou, P. L., Tao, K., Pond, S. L. K. & Shafer, R. W. Coronavirus ' 'Resistance Database (CoV-RDB): SARS-CoV-2 susceptibility to monoclonal ' 'antibodies, convalescent plasma, and plasma from vaccinated persons. ' 'PLoS One 17, e0261045 (2022).', 'journal-title': 'PLoS One'}, { 'key': '32551_CR27', 'doi-asserted-by': 'publisher', 'first-page': '1403', 'DOI': '10.1038/s41564-020-0770-5', 'volume': '5', 'author': 'A Rambaut', 'year': '2020', 'unstructured': 'Rambaut, A. et al. A dynamic nomenclature proposal for SARS-CoV-2 ' 'lineages to assist genomic epidemiology. Nat. Microbiol. 5, 1403–1407 ' '(2020).', 'journal-title': 'Nat. Microbiol.'}, { 'key': '32551_CR28', 'doi-asserted-by': 'crossref', 'unstructured': 'Aksamentov, I., Roemer, C., Hodcroft, E. & Neher, R. Nextclade: clade ' 'assignment, mutation calling and quality control for viral genomes. J. ' 'Open Source Softw. 6, 3773 (2021).', 'DOI': '10.21105/joss.03773'}], 'container-title': 'Nature Communications', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://www.nature.com/articles/s41467-022-32551-2.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://www.nature.com/articles/s41467-022-32551-2', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://www.nature.com/articles/s41467-022-32551-2.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2022, 8, 22]], 'date-time': '2022-08-22T15:05:51Z', 'timestamp': 1661180751000}, 'score': 1, 'resource': {'primary': {'URL': 'https://www.nature.com/articles/s41467-022-32551-2'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2022, 8, 22]]}, 'references-count': 28, 'journal-issue': {'issue': '1', 'published-online': {'date-parts': [[2022, 12]]}}, 'alternative-id': ['32551'], 'URL': 'http://dx.doi.org/10.1038/s41467-022-32551-2', 'relation': {}, 'ISSN': ['2041-1723'], 'subject': [ 'General Physics and Astronomy', 'General Biochemistry, Genetics and Molecular Biology', 'General Chemistry', 'Multidisciplinary'], 'container-title-short': 'Nat Commun', 'published': {'date-parts': [[2022, 8, 22]]}, 'assertion': [ { 'value': '4 May 2022', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '4 August 2022', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '22 August 2022', 'order': 3, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': 'K.W.C. has received research funding to the institution from Merck Sharp & ' 'Dohme and is a consultant for Pardes Biosciences. E.S.D. receives consulting ' 'fees from Gilead Sciences, Merck, and GSK/ViiV and research support through the ' 'institution from Gilead Sciences and GSK/ViiV. D.A.W. has received funding to ' 'the institution to support research and honoraria for advisory boards and ' 'consulting from Gilead Sciences. J.Z.L. has consulted for Abbvie. C.M. has ' 'received research funding to the institution from E.L. P.K., K.P., and A.N. are ' 'employees and shareholders of E.L. W.F. has received research funding to the ' 'institution from Ridgeback Biopharmaceuticals, served on adjudication ' 'committees for Janssen, Syneos, and consulted for Roche and Merck. J.J.E. is an ' 'ad hoc consultant to GSK/VIR, data monitoring committee (DMC) chair for Adagio ' 'Phase III studies. J.S.C. has consulted for Merck and Company. D.M.S. has ' 'consulted for the following companies Fluxergy, Kiadis, Linear Therapies, ' 'Matrix BioMed, Arena Pharmaceuticals, VxBiosciences, Model Medicines, Bayer ' 'Pharmaceuticals, Signant Health and Brio Clinical. All other authors (R.C., ' 'C.M., J.R., M.G., A.C.J., Y.L., M.C.C., R.D., V.B., R.M.R., A.S.P., C.V.F., and ' 'M.D.H.) report no competing interests.', 'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}], 'article-number': '4931'}
Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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