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Real-World Use of Sotrovimab for Pre-Emptive Treatment in High-Risk Hospitalized COVID-19 Patients: An Observational Cross-Sectional Study

Ong et al., Antibiotics, doi:10.3390/antibiotics11030345
Mar 2022  
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Mortality 61% Improvement Relative Risk ICU admission 56% Progression 59% Sotrovimab for COVID-19  Ong et al.  EARLY TREATMENT Is early treatment with sotrovimab beneficial for COVID-19? Retrospective 94 patients in Singapore Lower progression with sotrovimab (p=0.047) c19early.org Ong et al., Antibiotics, March 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 = 0.002 from 25 studies, recognized in 38 countries. Efficacy is variant dependent.
Lower risk for mortality, ICU, and hospitalization.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 112 treatments. c19early.org
Retrospective 19 sotrovimab patients and 75 controls is Singapore, showing lower progression with treatment.
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, XBB, XBB.1.5, ХВВ.1.9.17, XBB.1.16, BQ.1.1.45, and CL.15. US EUA has been revoked.
risk of death, 60.5% lower, RR 0.39, p = 0.45, treatment 1 of 19 (5.3%), control 10 of 75 (13.3%), NNT 12.
risk of ICU admission, 56.1% lower, RR 0.44, p = 0.35, treatment 2 of 19 (10.5%), control 18 of 75 (24.0%), NNT 7.4.
risk of progression, 59.0% lower, HR 0.41, p = 0.047, treatment 19, control 75, Cox proportional hazards.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Ong et al., 5 Mar 2022, retrospective, Singapore, peer-reviewed, 10 authors, average treatment delay 2.0 days.
This PaperSotrovimabAll
Real-World Use of Sotrovimab for Pre-Emptive Treatment in High-Risk Hospitalized COVID-19 Patients: An Observational Cross-Sectional Study
Sean W X Ong, Dongdong Ren, Pei Hua Lee, Stephanie Sutjipto, Christopher Dugan, Bo Yan Khoo, Jun Xin Tay, Shawn Vasoo, Barnaby E Young, David C Lye
Antibiotics, doi:10.3390/antibiotics11030345
Data on use of monoclonal antibodies (mAbs) in hospitalized patients are limited. In this cross-sectional study, we evaluated the use of mAbs for early treatment of unvaccinated hospitalized patients with mild-to-moderate COVID-19. All inpatients at our center were screened on 27 October 2021. Primary outcome was in-hospital deterioration as defined by a composite of oxygen requirement, intensive care unit (ICU) admission, or mortality within 28 days of admission. Ninety-four out of 410 COVID-19 inpatients were included in the final analysis, of whom 19 (20.2%) received early treatment with sotrovimab. The median age was 73 years (IQR 61-83), and 35 (37.2%) were female. Although the treatment group was significantly older and had more comorbidities, there was a lower proportion of progression to oxygen requirement (31.6% vs. 54.7%), ICU admission (10.5% vs. 24.0%), or mortality (5.3% vs. 13.3%). Kaplan-Meier curves showed a significant difference in time to in-hospital deterioration (log-rank test, p = 0.043). Cox proportional hazards model for in-hospital deterioration showed that sotrovimab treatment was protective (hazard ratio, 0.41; 95% CI, 0.17-0.99; p = 0.047) after adjustment for baseline ISARIC deterioration score. Our findings support the use of sotrovimab for early treatment in hospitalized patients with mild-to-moderate COVID-19 at a high risk of disease progression.
Informed Consent Statement: Patient consent was waived as approved by the institutional ethics committee for retrospective data collection without collection of individually identifiable patient identifiers. Data Availability Statement: The data presented in this study are available upon request from the corresponding author. Conflicts of Interest: BEY reports personal fees from Roche and Sanofi outside the submitted work. All other authors declare no competing interest.
References
Bierle, Ganesh, Tulledge-Scheitel, Hanson, Arndt et al., Monoclonal Antibody Treatment of Breakthrough COVID-19 in Fully Vaccinated Individuals with High-Risk Comorbidities, J. Infect. Dis, doi:10.1093/infdis/jiab570
Chemaitelly, Tang, Hasan, Al Mukdad, Yassine et al., Waning of BNT162b2 Vaccine Protection against SARS-CoV-2 Infection in Qatar, N. Engl. J. Med, doi:10.1056/NEJMoa2114114
Dagan, Barda, Kepten, Miron, Perchik et al., BNT162b2 mRNA COVID-19 Vaccine in a Nationwide Mass Vaccination Setting, N. Engl. J. Med, doi:10.1056/NEJMoa2101765
Dougan, Nirula, Azizad, Mocherla, Gottlieb et al., Bamlanivimab plus Etesevimab in Mild or Moderate COVID-19, N. Engl. J. Med, doi:10.1056/NEJMoa2102685
Gupta, Gonzalez-Rojas, Juarez, Casal, Moya et al., Early Treatment for COVID-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab, N. Engl. J. Med, doi:10.1056/NEJMoa2107934
Gupta, Harrison, Ho, Docherty, Knight et al., Development and validation of the ISARIC 4C Deterioration model for adults hospitalised with COVID-19: A prospective cohort study, Lancet Respir. Med, doi:10.1016/S2213-2600(20)30559-2
Iketani, Liu, Guo, Liu, Huang et al., Antibody Evasion Properties of SARS-CoV-2 Omicron Sublineages, bioRxiv, doi:10.1038/s41586-022-04594-4
Kreuzberger, Hirsch, Chai, Tomlinson, Khosravi et al., SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19, Cochrane Database Syst. Rev
Lundgren, Grund, A Neutralizing Monoclonal Antibody for Hospitalized Patients with COVID-19, N. Engl. J. Med
Ng, Koh, Chiew, Marimuthu, Thevasagayam et al., Impact of Delta Variant and Vaccination on SARS-CoV-2 Secondary Attack Rate Among Household Close Contacts, Lancet Reg. Health West. Pac, doi:10.1016/j.lanwpc.2021.100299
Ong, Sutjipto, Lee, Dugan, Khoo et al., Validation of ISARIC 4C mortality and deterioration scores in a mixed vaccination status cohort of hospitalized COVID-19 patients in Singapore, Clin. Infect. Dis, doi:10.1093/cid/ciac087
Tartof, Slezak, Fischer, Hong, Ackerson et al., Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: A retrospective cohort study, Lancet, doi:10.1016/S0140-6736(21)02183-8
Weinreich, Sivapalasingam, Norton, Ali, Gao et al., REGEN-COV Antibody Combination and Outcomes in Outpatients with COVID-19, N. Engl. J. Med, doi:10.1056/NEJMoa2108163
Wolter, Jassat, Walaza, Welch, Moultrie et al., Early assessment of the clinical severity of the SARS-CoV-2 omicron variant in South Africa: A data linkage study, Lancet, doi:10.1016/S0140-6736(22)00017-4
Young, Fong, Chang, Tan, Rouers et al., Comparison of the Clinical Features, viral Shedding and Immune Response in Vaccine Breakthrough Infection by the Omicron and Delta Variants
Zitek, Jodoin, Kheradia, Napolillo, Dalley et al., Vaccinated patients have reduced rates of hospitalization after receiving casirivimab and imdevimab for COVID-19, Am. J. Emerg. Med, doi:10.1016/j.ajem.2021.10.044
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