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0 0.5 1 1.5 2+ Death/hospitalization 51% Improvement Relative Risk Molnupiravir  Evans et al.  EARLY TREATMENT Is early treatment with molnupiravir beneficial for COVID-19? Retrospective 5,332 patients in the United Kingdom (Dec 2021 - Apr 2022) Lower death/hosp. with molnupiravir (p=0.0078) Evans et al., J. Infection, January 2023 Favors molnupiravir Favors control

Real-world effectiveness of molnupiravir, nirmatrelvir-ritonavir, and sotrovimab on preventing hospital admission among higher-risk patients with COVID-19 in Wales: A retrospective cohort study

Evans et al., Journal of Infection, doi:10.1016/j.jinf.2023.02.012
Jan 2023  
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Retrospective high risk outpatients in the UK, showing lower hospitalization/death with molnupiravir treatment. Residual confounding is likely with adjustments having no detail on specific comorbidities.
Concerns have been raised that the mutagenic mechanism of action may create dangerous variants or cause cancer Chamod, Hadj Hassine, Huntsman, Marikawa, Swanstrom, Waters, Zhou, Zibat. Multiple analyses have identified variants potentially created by molnupiravir Fountain-Jones, Kosakovsky Pond, Sanderson,
Study covers molnupiravir, sotrovimab, and paxlovid.
risk of death/hospitalization, 51.0% lower, HR 0.49, p = 0.008, treatment 359, control 4,973, Cox proportional hazards.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Evans et al., 25 Jan 2023, retrospective, United Kingdom, peer-reviewed, 11 authors, study period 16 December, 2021 - 22 April, 2022. Contact:,,,,,,,,,,
This PaperMolnupiravirAll
Real-world effectiveness of molnupiravir, nirmatrelvir-ritonavir, and sotrovimab on preventing hospital admission among higher-risk patients with COVID-19 in Wales: A retrospective cohort study
Andrew Evans, Cathy Qi, Jubril Omololu Adebayo, Jonathan Underwood, James Coulson, Rowena Bailey, Ronan Lyons, Adrian Edwards, Alison Cooper, Gareth John, Ashley Akbari
Journal of Infection, doi:10.1016/j.jinf.2023.02.012
Objective: To compare the effectiveness of molnupiravir, nirmatrelvir-ritonavir, and sotrovimab with no treatment in preventing hospital admission or death in higher-risk patients infected with SARS-CoV-2 in the community. Design: Retrospective cohort study of non-hospitalized adult patients with COVID-19 using the Secure Anonymised Information Linkage (SAIL) Databank. Setting: A real-world cohort study was conducted within the SAIL Databank (a secure trusted research environment containing anonymised, individual, population-scale electronic health record (EHR) data) for the population of Wales, UK. Participants: Adult patients with COVID-19 in the community, at higher risk of hospitalization and death, testing positive for SARS-CoV-2 between 16th December 2021 and 22nd April 2022. Interventions: Molnupiravir, nirmatrelvir-ritonavir, and sotrovimab given in the community by local health boards and the National Antiviral Service in Wales. Main outcome measures: All-cause admission to hospital or death within 28 days of a positive test for SARS-CoV-2. Statistical analysis: Cox proportional hazard model with treatment status (treated/untreated) as a timedependent covariate and adjusted for age, sex, number of comorbidities, Welsh Index of Multiple Deprivation, and vaccination status. Secondary subgroup analyses were by treatment type, number of comorbidities, and before and on or after 20th February 2022, when omicron BA.1 and omicron BA.2 were the dominant subvariants in Wales. Results: Between 16th December 2021 and 22nd April 2022, 7013 higher-risk patients were eligible for inclusion in the study. Of these, 2040 received treatment with molnupiravir (359, 17.6%), nirmatrelvir-ritonavir (602, 29.5%), or sotrovimab (1079, 52.9%). Patients in the treatment group were younger (mean age 53 vs 57 years), had fewer comorbidities, and a higher proportion had received four or more doses of the COVID-19 vaccine (36.3% vs 17.6%). Within 28 days of a positive test, 628 (9.0%) patients were admitted to hospital or died (84 treated and 544 untreated). The primary analysis indicated a lower risk of hospitalization or death at any point within 28 days in treated participants compared to those not receiving treatment. The adjusted hazard rate was 35% (95% CI: 18-49%) lower in treated than untreated participants. There was no indication of the superiority of one treatment over another and no evidence of a reduction in Journal of Infection xxx (xxxx) xxx-xxx
Ethics approval This project uses anonymised individual-level data sources held within the Trusted Research Environment provided by the SAIL Databank at Swansea University, Swansea, UK. All proposals to use SAIL data are subject to review by the independent Information Governance Review Panel (IGRP). This work was approved under proposal number 0911 after careful considerations by IGRP Panel. Access to data is gained through a privacy-protecting safe haven and remote access system referred to as the SAIL Gateway. CRediT authorship contribution statement All authors were involved in the Conceptualization and design of the study. AE, GJ, AA, CQ, LA and RB contributed to the acquisition of data. CQ, LA and RB carried out the statistical analysis. AE, CQ and LA drafted the original version of the manuscript. All authors contributed to the interpretation of the results and critical revision of the manuscript. All authors approved the final manuscript. AE is the guarantor for this study. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. Reporting We used the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) checklist to guide our transparent reporting of our work. A completed STROBE Statement -Checklist of items that should be included in reports of cohort studies is provided. Appendix A. Supplementary material Supplementary data associated with this article..
Bernal, Da Silva, Musungaie, Kovalchuk, Gonzalez et al., Molnupiravir for oral treatment of Covid-19 in nonhospitalized patients, N Engl J Med
Butler, Hobbs, Gbinigie, Rahman, Hayward et al., Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial, Lancet, doi:10.1016/S0140-6736(22)02597-1
Cheng, Reyes, Satram, Birch, Gibbons et al., Real-world effectiveness of sotrovimab for the early treatment of COVID-19 during SARS-CoV-2 Delta and Omicron waves in the United States
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Ford, Jones, Verplanke, Lyons, Brown, The SAIL databank: building a national architecture for e-health research and evaluation, BMC Health Serv Res
Gottlieb, Vaca, Paredes, Mera, Webb et al., Early remdesivir to prevent progression to severe Covid-19 in outpatients, N Engl J Med
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Government, Weekly COVID-19 treatment counts by therapeutic agent in Wales
Gupta, Gonzalez-Rojas, Juarez, Casal, Moya et al., Early treatment for Covid-19 with SARS-CoV-2 neutralizing antibody sotrovimab, N Engl J Med
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Koslov, Merck's COVID pill loses its lustre: what that means for the pandemic, Nature, doi:10.1038/d41586-021-03667-0
Lyons, Jones, John, Brooks, Verplanke et al., The SAIL databank: linking multiple health and social care datasets, BMC Med Inform Decis Mak
Najjar-Debbiny, Gronich, Weber, Khoury, Amar et al., Effectiveness of paxlovid in reducing severe COVID-19 and mortality in high risk patients, Clin Infect Dis
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Piccicacco, Zeitler, Ing, Montero, Faughn et al., Real-world effectiveness of early remdesivir and sotrovimab in the highest-risk COVID-19 outpatients during the Omicron surge, J Antimicrob Chemother
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Weinreich, Sivapalasingam, Norton, Ali, Gao et al., REGEN-COV antibody combination and outcomes in outpatients with Covid-19, N Engl J Med
Wu, Carr, Harvey, Mears, Kjaer et al., WHO's therapeutics and COVID-19 living guideline on mAbs needs to be reassessed, Lancet, doi:10.1016/S0140-6736(22)01938-9
Zheng, Green, Tazare, Curtis, Fisher et al., Comparative effectiveness of sotrovimab and molnupiravir for prevention of severe covid-19 outcomes in patients in the community: observational cohort study with the OpenSAFELY platform, BMJ
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