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Real-world effectiveness of sotrovimab in preventing hospitalization and mortality in high-risk patients with COVID-19 in the United States: A cohort study from the Mayo Clinic electronic health records

Bell et al., PLOS ONE, doi:10.1371/journal.pone.0304822
Jul 2024  
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Mortality 50% Improvement Relative Risk Death/hospitalization 12% ICU admission 74% Oxygen therapy 59% Hospitalization -20% Sotrovimab for COVID-19  Bell et al.  EARLY TREATMENT Is early treatment with sotrovimab beneficial for COVID-19? PSM retrospective 35,485 patients in the USA (May 2021 - Apr 2022) Lower ICU admission (p=0.0058) and lower oxygen therapy (p<0.0001) c19early.org Bell et al., PLOS ONE, July 2024 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 = 0.002 from 25 studies, recognized in 38 countries. Efficacy is variant dependent.
Lower risk for mortality, ICU admission, and hospitalization.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,800+ studies for 102 treatments. c19early.org
Retrospective 35,485 high-risk COVID-19 outpatients showing lower ICU admission and respiratory support with sotrovimab. There was no significant difference for hospitalization.
Confounding by treatment propensity. This study analyzes a population where only a fraction of eligible patients received the treatment. Patients receiving treatment may be more likely to follow other recommendations, more likely to receive additional care, and more likely to use additional treatments that are not tracked in the data (e.g., nasal/oral hygiene1,2, vitamin D3, etc.) — either because the physician recommending sotrovimab also recommended them, or because the patient seeking out sotrovimab is more likely to be familiar with the efficacy of additional treatments and more likely to take the time to use them. Therefore, these kind of studies may overestimate the efficacy of treatments.
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.14-6, BA.4, BA.57, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.18, and no efficacy for BA.29, ХВВ.1.9.1, XBB.1.16, BQ.1.1.45, and CL.18. US EUA has been revoked.
risk of death, 50.0% lower, RR 0.50, p = 0.20, treatment 5 of 854 (0.6%), control 20 of 1,708 (1.2%), NNT 171, propensity score matching.
risk of death/hospitalization, 12.5% lower, RR 0.88, p = 0.70, treatment 21 of 854 (2.5%), control 48 of 1,708 (2.8%), NNT 285, propensity score matching.
risk of ICU admission, 74.2% lower, RR 0.26, p = 0.006, treatment 4 of 854 (0.5%), control 31 of 1,708 (1.8%), NNT 74, propensity score matching.
risk of oxygen therapy, 59.5% lower, RR 0.41, p < 0.001, treatment 30 of 854 (3.5%), control 148 of 1,708 (8.7%), NNT 19, propensity score matching.
risk of hospitalization, 20.0% higher, RR 1.20, p = 0.54, treatment 18 of 854 (2.1%), control 30 of 1,708 (1.8%), propensity score matching.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Bell et al., 16 Jul 2024, retrospective, USA, peer-reviewed, 13 authors, study period 26 May, 2021 - 23 April, 2022. Contact: christopher.f.bell@gsk.com, nic@nference.net.
This PaperSotrovimabAll
Real-world effectiveness of sotrovimab in preventing hospitalization and mortality in high-risk patients with COVID-19 in the United States: A cohort study from the Mayo Clinic electronic health records
Christopher F Bell, Daniel C Gibbons, Myriam Drysdale, Helen J Birch, Emily J Lloyd, Vishal Patel, Corinne Carpenter, Katherine Carlson, Ediz S Calay, Arjun Puranik, Tyler E Wagner, John C O’horo, Raymund R Razonable
PLOS ONE, doi:10.1371/journal.pone.0304822
Background To describe outcomes of high-risk patients with coronavirus disease 2019 (COVID-19) treated with sotrovimab, other monoclonal antibodies (mAbs), or antivirals, and patients who did not receive early COVID-19 treatment. We also evaluate the comparative effectiveness of sotrovimab versus no treatment in preventing severe clinical outcomes. Methods This observational retrospective cohort study analyzed Mayo Clinic electronic health records. Non-hospitalized adult patients diagnosed with COVID-19 from May 26, 2021 and April 23, 2022 and at high risk of COVID-19 progression were eligible. The primary outcome was 29-day all-cause hospitalization and/or death. Outcomes were described for patients treated with sotrovimab, other mAbs, or antivirals, and eligible but untreated patients, and compared between sotrovimab-treated and propensity score (PS)-matched untreated cohorts. Results We included 35,485 patients (sotrovimab, 1369; other mAbs, 6488; antivirals, 133; high-risk untreated, 27,495). A low proportion of patients treated with sotrovimab (n = 33/1369, 2.4%), other mAbs (n = 147/6488, 2.3%), or antivirals (n = 2/133, 1.5%) experienced allcause hospitalization or death. Among high-risk untreated patients, the percentage of allcause hospitalization or death was 3.3% (n = 910/27,495). In the PS-matched analysis, 2.5% (n = 21/854) of sotrovimab-treated patients experienced all-cause hospitalization and/ or death versus 2.8% (n = 48/1708) of untreated patients (difference, -0.4%; p = 0.66).
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We also evaluate the comparative effectiveness of ' 'sotrovimab versus no treatment in preventing severe clinical outcomes.</jats:p>\n' '</jats:sec>\n' '<jats:sec id="sec002">\n' '<jats:title>Methods</jats:title>\n' '<jats:p>This observational retrospective cohort study analyzed Mayo Clinic electronic health ' 'records. Non-hospitalized adult patients diagnosed with COVID-19 from May 26, 2021 and April ' '23, 2022 and at high risk of COVID-19 progression were eligible. The primary outcome was ' '29-day all-cause hospitalization and/or death. Outcomes were described for patients treated ' 'with sotrovimab, other mAbs, or antivirals, and eligible but untreated patients, and compared ' 'between sotrovimab-treated and propensity score (PS)-matched untreated cohorts.</jats:p>\n' '</jats:sec>\n' '<jats:sec id="sec003">\n' '<jats:title>Results</jats:title>\n' '<jats:p>We included 35,485 patients (sotrovimab, 1369; other mAbs, 6488; antivirals, 133; ' 'high-risk untreated, 27,495). A low proportion of patients treated with sotrovimab (n = ' '33/1369, 2.4%), other mAbs (n = 147/6488, 2.3%), or antivirals (n = 2/133, 1.5%) experienced ' 'all-cause hospitalization or death. Among high-risk untreated patients, the percentage of ' 'all-cause hospitalization or death was 3.3% (n = 910/27,495). In the PS-matched analysis, ' '2.5% (n = 21/854) of sotrovimab-treated patients experienced all-cause hospitalization and/or ' 'death versus 2.8% (n = 48/1708) of untreated patients (difference, –0.4%; p = 0.66). 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WHO coronavirus (COVID-19) dashboard ' '[Internet]. 2023 November 8 [cited 2023 November 15]. 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' 'https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron.'}], 'container-title': 'PLOS ONE', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://dx.plos.org/10.1371/journal.pone.0304822', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2024, 7, 16]], 'date-time': '2024-07-16T17:26:04Z', 'timestamp': 1721150764000}, 'score': 1, 'resource': {'primary': {'URL': 'https://dx.plos.org/10.1371/journal.pone.0304822'}}, 'subtitle': [], 'editor': [{'given': 'Anmar', 'family': 'Al-Taie', 'sequence': 'first', 'affiliation': []}], 'short-title': [], 'issued': {'date-parts': [[2024, 7, 16]]}, 'references-count': 37, 'journal-issue': {'issue': '7', 'published-online': {'date-parts': [[2024, 7, 16]]}}, 'URL': 'http://dx.doi.org/10.1371/journal.pone.0304822', 'relation': {}, 'ISSN': ['1932-6203'], 'subject': [], 'container-title-short': 'PLoS ONE', 'published': {'date-parts': [[2024, 7, 16]]}}
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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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