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All Studies   Meta Analysis    Recent:   

Real-world effectiveness of early remdesivir and sotrovimab in the highest-risk COVID-19 outpatients during the Omicron surge

Piccicacco et al., Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkac256
Aug 2022  
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Mortality 66% Improvement Relative Risk Hospitalization 35% Hospitalization/ER 66% Progression, ER visit 90% Sotrovimab  Piccicacco et al.  EARLY TREATMENT Is early treatment with sotrovimab beneficial for COVID-19? Retrospective 178 patients in the USA (December 2021 - February 2022) Fewer hosp./ER visits (p=0.012) and lower progression (p=0.0095) c19early.org Piccicacco et al., J. Antimicrobial Ch.., Aug 2022 Favorssotrovimab Favorscontrol 0 0.5 1 1.5 2+
Sotrovimab for COVID-19
41st treatment shown to reduce risk in May 2023
 
*, now with p = 0.003 from 24 studies, recognized in 38 countries. Efficacy is variant dependent.
Lower risk for ICU admission and hospitalization.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 79 treatments. c19early.org
Retrospective high-risk outpatients in the USA, 82 treated with remdesivir, 88 with sotrovimab, and 90 control patients, showing significantly lower combined hospitalization/ER visits with both treatments in unadjusted results. The dominant variant was omicron B.1.1.529.
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.11-3, BA.4, BA.54, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.15, and no efficacy for BA.26, ХВВ.1.9.1, XBB.1.16, BQ.1.1.45, and CL.15. US EUA has been revoked.
Study covers remdesivir and sotrovimab.
risk of death, 66.4% lower, RR 0.34, p = 1.00, treatment 0 of 88 (0.0%), control 1 of 90 (1.1%), NNT 90, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 29.
risk of hospitalization, 34.9% lower, RR 0.65, p = 0.46, treatment 7 of 88 (8.0%), control 11 of 90 (12.2%), NNT 23, day 29.
risk of hospitalization/ER, 66.3% lower, RR 0.34, p = 0.01, treatment 7 of 88 (8.0%), control 21 of 90 (23.3%), NNT 6.5, odds ratio converted to relative risk, day 29.
risk of progression, 89.8% lower, RR 0.10, p = 0.009, treatment 1 of 88 (1.1%), control 10 of 90 (11.1%), NNT 10, ER visit, day 29.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Piccicacco et al., 1 Aug 2022, retrospective, USA, peer-reviewed, 7 authors, study period 27 December, 2021 - 4 February, 2022, average treatment delay 4.4 days. Contact: npiccicacco@tgh.org.
This PaperSotrovimabAll
Real-world effectiveness of early remdesivir and sotrovimab in the highest-risk COVID-19 outpatients during the Omicron surge
Nicholas Piccicacco, Kristen Zeitler, Austin Ing, Jose Montero, Jonathan Faughn, Suzane Silbert, Kami Kim
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkac256
Background: Remdesivir and sotrovimab both have clinical trial data in the outpatient setting demonstrating reduction in the risk of hospitalizations and emergency department (ED) visits related to COVID-19. Objectives: To evaluate the effectiveness of remdesivir in comparison with sotrovimab and matched high-risk control patients in preventing COVID-19-related hospitalizations and ED visits during the Omicron B.1.1.529 surge. Patients and methods: This retrospective cohort study included outpatients positive for SARS-CoV-2, with nonsevere symptoms for ≤7 days and deemed high-risk for severe COVID-19 by an internal scoring matrix. Patients who received remdesivir or sotrovimab from 27/12/2021 to 04/02/2022 were included (n = 82 and n = 88, respectively). These were compared with a control cohort of high-risk COVID-19 outpatients who did not receive therapy (n = 90). The primary outcome was a composite of 29 day COVID-19-related hospitalizations and/or ED visits. Pre-specified secondary outcomes included components of the primary endpoint, 29 day all-cause mortality and serious adverse drug events. Results: Patients treated with remdesivir were significantly less likely to be hospitalized or visit the ED within 29 days from symptom onset (11% versus 23.3%; OR = 0.41, 95% CI = 0.17-0.95). Patients receiving sotrovimab were also less likely to be hospitalized or visit the ED (8% versus 23.3%; OR = 0.28, 95% CI = 0.11-0.71). There was no difference in the incidence of hospitalizations/ED visits between sotrovimab and remdesivir. Conclusions: Our highest-risk outpatients with Omicron-related COVID-19 who received early sotrovimab or remdesivir had significantly lower likelihoods of a hospitalization and/or ED visit.
Author contributions Concept and design: N.P., K.Z., A.I. and J.M. Acquisition, analysis or interpretation of data: N.P., K.Z., A.I. and J.M. Drafting of manuscript: N.P., A.I., K.Z., J.F. and S.S. Critical revision of the manuscript for important intellectual content: K.K. and J.M. Statistical analysis: N.P. and K.Z. Supplementary data Table S1 is available as Supplementary data at JAC Online.
References
Agarwal, Rochwerg, Lamontagne, A living WHO guideline on drugs for covid-19, BMJ, doi:10.1136/bmj.m3379
Andrews, Stowe, Kirsebom, Covid-19 vaccine effectiveness against the Omicron (B.1.1.529) variant, N Engl J Med, doi:10.1056/NEJMoa2119451
Bhimraj, Morgan, Shumaker, IDSA Guidelines on the Treatment and Management of Patients with COVID-19
Fda, FDA Takes Actions to Expand Use of Treatment for Outpatients With Mild-to-Moderate COVID-19
Gottlieb, Vaca, Paredes, Early remdesivir to prevent progression to severe Covid-19 in outpatients, N Engl J Med, doi:10.1056/NEJMoa2116846
Gupta, Gonzalez-Rojas, Juarez, Effect of sotrovimab on hospitalization or death among high-risk patients with mild to moderate COVID-19: a randomized clinical trial, JAMA, doi:10.1001/jama.2022.2832
Hui, Ho, Cheung, SARS-CoV-2 Omicron variant replication in human bronchus and lung ex vivo, Nature, doi:10.1038/s41586-022-04479-6
Iuliano, Brunkard, Boehmer, Trends in disease severity and health care utilization during the early Omicron variant period compared with previous SARS-CoV-2 high transmission periods -United States, December 2020-January 2022, MMWR Morb Mortal Wkly Rep, doi:10.15585/mmwr.mm7104e4
Lee, Wong, Chai, Efficacy of covid-19 vaccines in immunocompromised patients: systematic review and meta-analysis, BMJ, doi:10.1136/bmj-2021-068632
Peters, Rabinstein, Dubrock, Use of remdesivir in myasthenia gravis and COVID-19, Pharmacotherapy, doi:10.1002/phar.2524
Piccicacco, Zeitler, Montero, Effectiveness of severe acute respiratory syndrome coronavirus 2 monoclonal antibody infusions in high-risk outpatients, Open Forum Infect Dis, doi:10.1093/ofid/ofab292
Planas, Saunders, Maes, Considerable escape of SARS-CoV-2 Omicron to antibody neutralization, Nature, doi:10.1038/s41586-021-04389-z
Razonable, Ganesh, Bierle, Clinical prioritization of antispike monoclonal antibody treatment of mild to moderate Outpatient remdesivir versus sotrovimab for Omicron COVID-19, Mayo Clin Proc, doi:10.1016/j.mayocp.2021.11.017
Stolle, Nalamasu, Pergolizzi, Fact vs fallacy: the anti-vaccine discussion reloaded, Adv Ther, doi:10.1007/s12325-020-01502-y
Tseng, Ackerson, Luo, Effectiveness of mRNA-1273 against SARS-CoV-2 Omicron and Delta variants, Nat Med, doi:10.1038/s41591-022-01753-y
Yek, Warner, Wiltz, Risk factors for severe COVID-19 outcomes among persons aged ≥18 years who completed a primary COVID-19 vaccination series -465 health care facilities, United States, MMWR Morb Mortal Wkly Rep, doi:10.15585/mmwr.mm7101a4
Zhu, Zhang, A novel coronavirus from patients with pneumonia in China, 2019, N Engl J Med, doi:10.1056/NEJMoa2001017
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Patients who received remdesivir or sotrovimab from ' '27/12/2021 to 04/02/2022 were included (n\u200a=\u200a82 and n\u200a=\u200a88, respectively). ' 'These were compared with a control cohort of high-risk COVID-19 outpatients who did not ' 'receive therapy (n\u200a=\u200a90). The primary outcome was a composite of 29\u2005day ' 'COVID-19-related hospitalizations and/or ED visits. Pre-specified secondary outcomes included ' 'components of the primary endpoint, 29\u2005day all-cause mortality and serious adverse drug ' 'events.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>Patients treated with remdesivir were significantly less likely to ' 'be hospitalized or visit the ED within 29\u2005days from symptom onset (11% versus 23.3%; ' 'OR\u200a=\u200a0.41, 95% CI\u200a=\u200a0.17–0.95). Patients receiving sotrovimab were also ' 'less likely to be hospitalized or visit the ED (8% versus 23.3%; OR\u200a=\u200a0.28, 95% ' 'CI\u200a=\u200a0.11–0.71). There was no difference in the incidence of hospitalizations/ED ' 'visits between sotrovimab and remdesivir.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>Our highest-risk outpatients with Omicron-related COVID-19 who ' 'received early sotrovimab or remdesivir had significantly lower likelihoods of a ' 'hospitalization and/or ED visit.</jats:p>\n' ' </jats:sec>', 'DOI': '10.1093/jac/dkac256', 'type': 'journal-article', 'created': {'date-parts': [[2022, 8, 1]], 'date-time': '2022-08-01T16:50:21Z', 'timestamp': 1659372621000}, 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Real-world effectiveness of early remdesivir and sotrovimab in the highest-risk COVID-19 ' 'outpatients during the Omicron surge', 'prefix': '10.1093', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-6246-7533', 'authenticated-orcid': False, 'given': 'Nicholas', 'family': 'Piccicacco', 'sequence': 'first', 'affiliation': [ { 'name': 'Department of Pharmacy, Tampa General Hospital , Tampa, FL , ' 'USA'}]}, { 'given': 'Kristen', 'family': 'Zeitler', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Pharmacy, Tampa General Hospital , Tampa, FL , ' 'USA'}]}, { 'given': 'Austin', 'family': 'Ing', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Pharmacy, Vanderbilt University Medical Center , ' 'Nashville, TN , USA'}]}, { 'given': 'Jose', 'family': 'Montero', 'sequence': 'additional', 'affiliation': [ { 'name': 'Division of Infectious Diseases, Department of Internal ' 'Medicine, University of South Florida Morsani College of ' 'Medicine , Tampa, FL , USA'}]}, { 'given': 'Jonathan', 'family': 'Faughn', 'sequence': 'additional', 'affiliation': [ { 'name': 'Esoteric Testing/R&D and Microbiology Laboratories, Tampa ' 'General Hospital , Tampa, FL , USA'}]}, { 'given': 'Suzane', 'family': 'Silbert', 'sequence': 'additional', 'affiliation': [ { 'name': 'Esoteric Testing/R&D and Microbiology Laboratories, Tampa ' 'General Hospital , Tampa, FL , USA'}]}, { 'ORCID': 'http://orcid.org/0000-0003-3384-152X', 'authenticated-orcid': False, 'given': 'Kami', 'family': 'Kim', 'sequence': 'additional', 'affiliation': [ { 'name': 'Division of Infectious Diseases, Department of Internal ' 'Medicine, University of South Florida Morsani College of ' 'Medicine , Tampa, FL , USA'}, { 'name': 'Global Emerging Diseases Institute, Tampa General Hospital , ' 'Tampa, FL , USA'}]}], 'member': '286', 'published-online': {'date-parts': [[2022, 8, 1]]}, 'reference': [ {'key': '2022080116401611900_dkac256-B1', 'author': 'Johns Hopkins University'}, { 'key': '2022080116401611900_dkac256-B2', 'doi-asserted-by': 'crossref', 'first-page': '727', 'DOI': '10.1056/NEJMoa2001017', 'article-title': 'A novel coronavirus from patients with pneumonia in China, 2019', 'volume': '382', 'author': 'Zhu', 'year': '2020', 'journal-title': 'N Engl J Med'}, {'key': '2022080116401611900_dkac256-B3', 'author': 'CDC'}, { 'key': '2022080116401611900_dkac256-B4', 'doi-asserted-by': 'crossref', 'first-page': '19', 'DOI': '10.15585/mmwr.mm7101a4', 'article-title': 'Risk factors for severe COVID-19 outcomes among persons aged ≥18 years ' 'who completed a primary COVID-19 vaccination series - 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