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All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Mortality -401% Improvement Relative Risk Hospitalization -101% Progression -503% Sotrovimab  COMET-TAIL  EARLY TREATMENT  RCT Is early treatment with sotrovimab beneficial for COVID-19? RCT 982 patients in the USA (August 2020 - March 2021) Trial compares with intravenous sotrovimab Higher mortality (p=0.25) and hospitalization (p=0.2), not sig. c19early.org Shapiro et al., medRxiv, March 2023 Favors sotrovimab Favors intravenous ..

Intramuscular Versus Intravenous SARS-CoV-2 Neutralizing Antibody Sotrovimab for Treatment of COVID-19 (COMET-TAIL): A Randomized Non-inferiority Clinical Trial

Shapiro et al., medRxiv, doi:10.1101/2023.03.21.23287410, COMET-TAIL, NCT04913675
Mar 2023  
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Sotrovimab for COVID-19
39th treatment shown to reduce risk in May 2023
 
*, now known with p = 0.0017 from 22 studies, recognized in 37 countries. Efficacy is variant dependent.
Lower risk for hospitalization.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,200+ studies for 70+ treatments. c19early.org
RCT 982 high risk outpatients in the USA reporting that intramuscular sotrovimab was non-inferior to intravenous administration. Death and hospitalization was more frequent with intramuscular administration, without statistical significance due to the small number of events.
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.1 Liu, Sheward, VanBlargan, BA.4, BA.5 Haars, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.1 Pochtovyi, and no efficacy for BA.2 Zhou, ХВВ.1.9.1, XBB.1.16, BQ.1.1.45, and CL.1 Pochtovyi. US EUA has been revoked.
risk of death, 401.1% higher, RR 5.01, p = 0.25, treatment 2 of 376 (0.5%), control 0 of 378 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of hospitalization, 101.1% higher, RR 2.01, p = 0.20, treatment 10 of 376 (2.7%), control 5 of 378 (1.3%).
risk of progression, 503.2% higher, RR 6.03, p = 0.07, treatment 6 of 376 (1.6%), control 1 of 378 (0.3%), progression to severe.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Shapiro et al., 24 Mar 2023, Randomized Controlled Trial, USA, preprint, 28 authors, study period August 2020 - March 2021, this trial compares with another treatment - results may be better when compared to placebo, trial NCT04913675 (history) (COMET-TAIL). Contact: akohli@azliver.com, lgaffney@vir.bio.
This PaperSotrovimabAll
Intramuscular Versus Intravenous SARS-CoV-2 Neutralizing Antibody Sotrovimab for Treatment of COVID-19 (COMET-TAIL): A Randomized Non-inferiority Clinical Trial
Adrienne E Shapiro, Elias Sarkis, Jude Acloque, Almena Free, Yaneicy Gonzalez-Rojas, Rubaba Hussain, Erick Juarez, Jaynier Moya, Naval Parikh, David Inman, Deborah Cebrik, Ahmed Nader, Nadia Noormohamed, Qianwen Wang, Andrew Skingsley, Daren Austin, Amanda Peppercorn, Maria L Agostini, Sergio Parra, Sophia Chow, Erik Mogalian, Phillip S Pang, David K Hong, Jennifer E Sager, Wendy W Yeh, Vir Biotechnology, Inc Elizabeth L Alexander, Dr Leah A Gaffney, Dr Anita Kohli
doi:10.1101/2023.03.21.23287410
Sotrovimab 500-mg IM was non-inferior to sotrovimab 500-mg IV for treatment of mild/moderate COVID-19 in high-risk patients, measured by all-cause hospitalization >24h or death through day 29, and was well-tolerated. Sotrovimab IM should provide easier outpatient access to COVID-19 treatment.
Funding The study was supported by Vir Biotechnology, Inc. in collaboration with GSK. Author Contributions PSP, DKH, EA, WWY, EM, JES, DA, SC, and AP conceptualized and designed the study. All authors acquired, analyzed and/or interpreted the data. DI and DC conducted the statistical analyses. AK, LAG, and DI accessed and verified the data. All authors drafted the manuscript and critically reviewed and revised the manuscript for important intellectual content. All authors had full access to all the data in the study, take responsibility for the accuracy of the analysis, and had authority over manuscript preparation and the decision to submit the manuscript for publication. Conflict of Interest Disclosures
References
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Gupta, Gonzalez-Rojas, Juarez, Early COVID-19 treatment with SARS-CoV-2 neutralizing antibody sotrovimab, N Engl J Med
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
Harman, Nash, Webster, Comparison of the risk of hospitalization among BA.1 and BA.2 COVID-19 cases treated with sotrovimab in the community in England. medRxiv, doi:10.1101/2022.10.21.22281171
Martin-Blondel, Marcelin, Soulie, Sotrovimab to prevent severe COVID-19 in high-risk patients infected with Omicron BA.2, J Infect
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Sager, El-Zailik, Passarell, Population pharmacokinetics and exposureresponse analysis of sotrovimab in the early treatment of COVID-19, CPT Pharmacometrics Syst Pharmacol, doi:10.1002/psp4.12958
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Weinreich, Sivapalasingam, Norton, REGEN-COV antibody combination and outcomes in outpatients with COVID-19, N Engl J Med
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Zheng, Tazare, Nab, Comparative effectiveness of Paxlovid versus sotrovimab and molnupiravir for preventing severe COVID-19 outcomes in nonhospitalised patients: observational cohort study using the OpenSAFELY platform, medRxiv, doi:10.1101/2023.01.20.23284849
{ 'DOI': '10.1101/2023.03.21.23287410', 'URL': 'http://dx.doi.org/10.1101/2023.03.21.23287410', 'abstract': '<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Convenient ' 'administration of coronavirus disease 2019 (COVID-19) treatment in community settings is ' 'desirable. Sotrovimab is a pan-sarbecovirus dual-action monoclonal antibody formulated for ' 'intravenous (IV) or intramuscular (IM) administration for early treatment of mild/moderate ' 'COVID-19.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>This phase 3, ' 'randomized, multicenter, open-label study tested non-inferiority of IM to IV administration ' 'using a 3.5% absolute non-inferiority margin. From June to August 2021, patients aged ≥12 ' 'years with COVID-19, not hospitalized or receiving supplemental oxygen, and at high risk for ' 'progression were randomized 1:1:1 to a single 500-mg IV sotrovimab infusion or 500-mg or ' '250-mg IM sotrovimab injection. The primary composite endpoint was progression to all-cause ' 'hospitalization for &gt;24 hours for acute management of illness or all-cause death through ' 'day 29.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Sotrovimab 500 ' 'mg IM was non-inferior to 500 mg IV: 10/376 (2.7%) participants in the sotrovimab 500-mg IM ' 'group versus 5/378 (1.3%) in the sotrovimab 500-mg IV group met the primary endpoint ' '(absolute adjusted risk difference: 1.06% [95% confidence interval [CI]: −1.15%, 3.26%]). The ' 'CI upper limit was lower than the prespecified non-inferiority margin of 3.5%. 250-mg IM ' 'group enrollment was discontinued early because a greater proportion of hospitalizations was ' 'seen in that group versus the 500-mg groups. Serious adverse events occurred in &lt;1% to 2% ' 'of participants across groups. Four participants experienced serious disease related events ' 'and died (500 mg IM: 2/393 [&lt;1%]; 250 mg IM: 2/195 ' '[1%]).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Sotrovimab ' '500-mg IM injection was well tolerated and non-inferior to IV administration. IM ' 'administration could expand outpatient treatment access for ' 'COVID-19.</jats:p></jats:sec><jats:sec><jats:title>Registration</jats:title><jats:p><jats:ext-link ' 'xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" ' 'xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</jats:ext-link>Identifier:<jats:ext-link ' 'xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" ' 'xlink:href="NCT04913675">NCT04913675</jats:ext-link></jats:p></jats:sec><jats:sec><jats:title>Key ' 'Points</jats:title><jats:p>Sotrovimab 500-mg IM was non-inferior to sotrovimab 500-mg IV for ' 'treatment of mild/moderate COVID-19 in high-risk patients, measured by all-cause ' 'hospitalization &gt;24h or death through day 29, and was well-tolerated. Sotrovimab IM should ' 'provide easier outpatient access to COVID-19 treatment.</jats:p></jats:sec>', 'accepted': {'date-parts': [[2023, 3, 24]]}, 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-3106-1258', 'affiliation': [], 'authenticated-orcid': False, 'family': 'Shapiro', 'given': 'Adrienne E.', 'sequence': 'first'}, {'affiliation': [], 'family': 'Sarkis', 'given': 'Elias', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Acloque', 'given': 'Jude', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Free', 'given': 'Almena', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Gonzalez-Rojas', 'given': 'Yaneicy', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Hussain', 'given': 'Rubaba', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Juarez', 'given': 'Erick', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Moya', 'given': 'Jaynier', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Parikh', 'given': 'Naval', 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