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Does early combination vs. Monotherapy improve clinical outcomes of clinically extremely vulnerable patients with COVID-19? Results from a retrospective propensity-weighted analysis

Maria et al., European Journal of Medical Research, doi:10.1186/s40001-024-02062-5
Oct 2024  
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Mortality 72% Improvement Relative Risk Progression 77% Sotrovimab for COVID-19  Maria et al.  EARLY TREATMENT Is early treatment with sotrovimab beneficial for COVID-19? Retrospective 81 patients in Italy (January 2022 - December 2023) Lower progression with sotrovimab (p=0.03) c19early.org Maria et al., European J. Medical Rese.., Oct 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, and hospitalization.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 112 treatments. c19early.org
Retrospective 81 severely immunocompromised COVID-19 outpatients in Italy showing improved composite outcome of death, hospitalization, and emergency department encounters with early combination therapy of an antiviral plus sotrovimab compared to antiviral monotherapy.
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 US EUA has been revoked.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, 72.0% lower, OR 0.28, p = 0.15, treatment 39, control 42, propensity score weighting, RR approximated with OR.
risk of progression, 77.0% lower, OR 0.23, p = 0.03, treatment 39, control 42, propensity score weighting, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Maria et al., 4 Oct 2024, retrospective, Italy, peer-reviewed, 10 authors, study period 1 January, 2022 - 31 December, 2023, average treatment delay 2.0 days. Contact: m.mazzitelli88@gmail.com.
This PaperSotrovimabAll
Does early combination vs. Monotherapy improve clinical outcomes of clinically extremely vulnerable patients with COVID-19? Results from a retrospective propensity-weighted analysis
Mazzitelli Maria, Alberto Enrico Maraolo, Claudia Cozzolino, Lolita Sasset, Anna Ferrari, Monica Basso, Eleonora Vania, Nicola Bonadiman, Vincenzo Scaglione, Anna Maria Cattelan
European Journal of Medical Research, doi:10.1186/s40001-024-02062-5
Background The potential efficacy of early combination therapy, based on an antiviral plus a monoclonal antibody, for COVID-19 in severely immunocompromised patients is matter of debate. Objectives Our aim was to describe the impact on clinical outcomes of COVID-19 treatments in severely immunocompromised individuals, evaluating differences between a combination and a monotherapy. Methods We included severely immunocompromised outpatients with mild-to-moderate COVID-19 who received an early treatment (either monotherapy with nirmatrelvir/ritonavir or remdesivir or the combination of an antiviral plus sotrovimab). We then assessed differences between the two treatment strategies on three main outcomes (30day mortality, access to emergency department, hospitalization), separately and as a composite by using a propensity score weighted (PSW) approach. Results Eighty one severely immunocompromised patients were included, 39 receiving early combination therapy and 42 receiving monotherapy. No significant difference was observed in the 30-day mortality rate and hospitalization rate between subjects in the two groups, while access to the emergency department following treatment administration was significantly higher in people who received a combination therapy. After applying the PSW, it was observed that combination therapy impacted favourably on the composite outcome, in a statistically significant fashion. In addition, PSW approach for mortality showed that age was the only significant factor influencing the death as stand-alone outcome. Conclusions Early combination therapy showed a favourable impact on a composite outcome (including mortality, hospitalizations and access to emergency department) in severely immunocompromised hosts who were all vaccinated. However, further studies are needed to support our results.
Supplementary Information The online version contains supplementary material available at https:// doi . org/ 10. 1186/ s40001-024-02062-5. Supplementary Material 1 Author contributions M.M. conceived the study. A.M. performed statistical analysis. M.M. and A.M wrote the draft of the manuscript. C.C., M.B., L.S., A.F, V.S., N.B. and E.V. curated and collected the data. A.M.C. supervised the project. All authors reviewed, approved the final version of the manuscript, and by having access to all the data had final responsibility for the decision to submit this paper for publication. Declarations Ethics approval and consent to participate Study protocol was approved by Local Ethic Committee (n. AOP 0002323, January 1rst, 2022). Each patient was requested to sign written informed consent for participation. Competing interests Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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' 'https://doi.org/10.1093/cid/ciac724.', 'journal-title': 'Clin Infect Dis'}, { 'issue': '1', 'key': '2062_CR36', 'doi-asserted-by': 'publisher', 'first-page': '883', 'DOI': '10.1186/s12879-022-07871-9', 'volume': '22', 'author': 'V Scaglione', 'year': '2022', 'unstructured': 'Scaglione V, Rotundo S, Marascio N, De Marco C, Lionello R, Veneziano C, ' 'et al. Publisher Correction: Lessons learned and implications of early ' 'therapies for coronavirus disease in a territorial service centre in the ' 'Calabria region: a retrospective study. BMC Infect Dis. 2022;22(1):883. ' 'https://doi.org/10.1186/s12879-022-07871-9.', 'journal-title': 'BMC Infect Dis'}, { 'issue': '1', 'key': '2062_CR37', 'doi-asserted-by': 'publisher', 'first-page': '564', 'DOI': '10.1186/s12879-024-09466-y', 'volume': '24', 'author': 'S Rotundo', 'year': '2024', 'unstructured': 'Rotundo S, Berardelli L, Gulli S, La Gamba V, Lionello R, Russo A, et ' 'al. Early initiation of combined therapy in severely immunocompromised ' 'patients with COVID-19: a retrospective cohort study. BMC Infect Dis. ' '2024;24(1):564. https://doi.org/10.1186/s12879-024-09466-y.', 'journal-title': 'BMC Infect Dis'}, { 'key': '2062_CR38', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/j.lanepe.2023.100747', 'volume': '35', 'author': 'RA Evans', 'year': '2023', 'unstructured': 'Evans RA, Dube S, Lu Y, Yates M, Arnetorp S, Barnes E, et al. Impact of ' 'COVID-19 on immunocompromised populations during the Omicron era: ' 'insights from the observational population-based INFORM study. Lancet ' 'Reg Health Eur. 2023;35: 100747. ' 'https://doi.org/10.1016/j.lanepe.2023.100747.', 'journal-title': 'Lancet Reg Health Eur'}, { 'key': '2062_CR39', 'doi-asserted-by': 'publisher', 'DOI': '10.1093/cid/ciae308', 'author': 'M Boeckh', 'year': '2024', 'unstructured': 'Boeckh M, Pergam SA, Limaye AP, Englund J, Corey L, Hill JA. How ' 'immunocompromised hosts were left behind in the quest to control the ' 'Covid-19 Pandemic. Clin Infect Dis. 2024. ' 'https://doi.org/10.1093/cid/ciae308.', 'journal-title': 'Clin Infect Dis'}, { 'key': '2062_CR40', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/S1473-3099(23)00815-0', 'author': 'HM Machkovech', 'year': '2024', 'unstructured': 'Machkovech HM, Hahn AM, Garonzik Wang J, Grubaugh ND, Halfmann PJ, ' 'Johnson MC, et al. Persistent SARS-CoV-2 infection: significance and ' 'implications. Lancet Infect Dis. 2024. ' 'https://doi.org/10.1016/S1473-3099(23)00815-0.', 'journal-title': 'Lancet Infect Dis'}, { 'key': '2062_CR41', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/j.cmi.2024.05.022', 'author': 'SE Meijer', 'year': '2024', 'unstructured': 'Meijer SE, Paran Y, Belkin A, Brosh-Nissimov T. ’Persistent COVID-19 in ' 'immunocompromised patients—Israeli society of infectious diseases ' 'consensus statement on diagnosis and management’—Author’s reply. Clin ' 'Microbiol Infect. 2024. https://doi.org/10.1016/j.cmi.2024.05.022.', 'journal-title': 'Clin Microbiol Infect'}, { 'key': '2062_CR42', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/j.cmi.2024.05.011', 'author': 'AE Maraolo', 'year': '2024', 'unstructured': 'Maraolo AE, Moriello NS, Gentile I. Re: Persistent COVID-19 in ' 'immunocompromised patients—Israeli Society of Infectious Diseases ' 'consensus statement on diagnosis and management by Meijer et al. Clin ' 'Microbiol Infect. 2024. https://doi.org/10.1016/j.cmi.2024.05.011.', 'journal-title': 'Clin Microbiol Infect'}, { 'key': '2062_CR43', 'doi-asserted-by': 'publisher', 'first-page': '55', 'DOI': '10.1016/j.ijid.2023.09.021', 'volume': '137', 'author': 'D Focosi', 'year': '2023', 'unstructured': 'Focosi D, Maggi F, D’Abramo A, Nicastri E, Sullivan DJ. Antiviral ' 'combination therapies for persistent COVID-19 in immunocompromised ' 'patients. Int J Infect Dis. 2023;137:55–9. ' 'https://doi.org/10.1016/j.ijid.2023.09.021.', 'journal-title': 'Int J Infect Dis'}, { 'issue': '2', 'key': '2062_CR44', 'doi-asserted-by': 'publisher', 'first-page': '283', 'DOI': '10.1093/jac/dkaa442', 'volume': '76', 'author': 'J Sundararaj Stanleyraj', 'year': '2021', 'unstructured': 'Sundararaj Stanleyraj J, Sethuraman N, Gupta R, Thiruvoth S, Gupta M, ' 'Ryo A. Treating COVID-19: are we missing out the window of opportunity? ' 'J Antimicrob Chemother. 2021;76(2):283–5. ' 'https://doi.org/10.1093/jac/dkaa442.', 'journal-title': 'J Antimicrob Chemother'}, { 'issue': '1', 'key': '2062_CR45', 'doi-asserted-by': 'publisher', 'first-page': 'e13', 'DOI': '10.1016/S2666-5247(20)30172-5', 'volume': '2', 'author': 'M Cevik', 'year': '2021', 'unstructured': 'Cevik M, Tate M, Lloyd O, Maraolo AE, Schafers J, Ho A. SARS-CoV-2, ' 'SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, ' 'and infectiousness: a systematic review and meta-analysis. Lancet ' 'Microbe. 2021;2(1):e13–22. ' 'https://doi.org/10.1016/S2666-5247(20)30172-5.', 'journal-title': 'Lancet Microbe'}, { 'issue': '2', 'key': '2062_CR46', 'doi-asserted-by': 'publisher', 'first-page': '217', 'DOI': '10.3390/v16020217', 'volume': '16', 'author': 'D Focosi', 'year': '2024', 'unstructured': 'Focosi D, Casadevall A, Franchini M, Maggi F. Sotrovimab: a review of ' 'its efficacy against SARS-CoV-2 variants. Viruses. 2024;16(2):217. ' 'https://doi.org/10.3390/v16020217.', 'journal-title': 'Viruses'}, { 'issue': '8', 'key': '2062_CR47', 'doi-asserted-by': 'publisher', 'first-page': '1757', 'DOI': '10.3390/v15081757', 'volume': '15', 'author': 'A De Vito', 'year': '2023', 'unstructured': 'De Vito A, Colpani A, Poliseno M, Diella L, Ieva FRP, Belati A, et al. ' 'What is the efficacy of sotrovimab in reducing disease progression and ' 'death in people with COVID-19 during the Omicron Era? Answers from a ' 'real-life study. Viruses. 2023;15(8):1757. ' 'https://doi.org/10.3390/v15081757.', 'journal-title': 'Viruses'}, { 'issue': '51', 'key': '2062_CR48', 'doi-asserted-by': 'publisher', 'first-page': '1357', 'DOI': '10.15585/mmwr.mm7251a1', 'volume': '72', 'author': 'DJ Smith', 'year': '2023', 'unstructured': 'Smith DJ, Lambrou A, Patel P. SARS-CoV-2 rebound with and without use of ' 'COVID-19 oral antivirals. MMWR Morb Mortal Wkly Rep. ' '2023;72(51):1357–64. https://doi.org/10.15585/mmwr.mm7251a1.', 'journal-title': 'MMWR Morb Mortal Wkly Rep'}, { 'issue': '11', 'key': '2062_CR49', 'doi-asserted-by': 'publisher', 'DOI': '10.1002/jmv.29228', 'volume': '95', 'author': 'SW Kang', 'year': '2023', 'unstructured': 'Kang SW, Kim JW, Kim JY, Lim SY, Jang CY, Chang E, et al. Virological ' 'characteristics and the rapid antigen test as deisolation criteria in ' 'immunocompromised patients with COVID-19: a prospective cohort study. J ' 'Med Virol. 2023;95(11): e29228. https://doi.org/10.1002/jmv.29228.', 'journal-title': 'J Med Virol'}], 'container-title': 'European Journal of Medical Research', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://link.springer.com/content/pdf/10.1186/s40001-024-02062-5.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/article/10.1186/s40001-024-02062-5/fulltext.html', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/content/pdf/10.1186/s40001-024-02062-5.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2024, 10, 4]], 'date-time': '2024-10-04T07:05:19Z', 'timestamp': 1728025519000}, 'score': 1, 'resource': { 'primary': { 'URL': 'https://eurjmedres.biomedcentral.com/articles/10.1186/s40001-024-02062-5'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2024, 10, 4]]}, 'references-count': 49, 'journal-issue': {'issue': '1', 'published-online': {'date-parts': [[2024, 12]]}}, 'alternative-id': ['2062'], 'URL': 'http://dx.doi.org/10.1186/s40001-024-02062-5', 'relation': {}, 'ISSN': ['2047-783X'], 'subject': [], 'container-title-short': 'Eur J Med Res', 'published': {'date-parts': [[2024, 10, 4]]}, 'assertion': [ { 'value': '3 August 2024', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '12 September 2024', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '4 October 2024', 'order': 3, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, {'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Declarations'}}, { 'value': 'Study protocol was approved by Local Ethic Committee (n. AOP 0002323, January ' '1rst, 2022). Each patient was requested to sign written informed consent for ' 'participation.', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Ethics approval and consent to participate'}}, { 'value': 'M.M. and A.C. received a research grant from Gilead Sciences, speakers’ ' 'honoraria from ViiV Healthcare, Gilead Sciences, and Merck Sharp & Dohme, and ' 'advisory board fees from ViiV Healthcare. V.S. received speakers’ honoraria ' 'from Angelini. All the other authors do not have any conflicts of interest to ' 'disclose. The authors declare no competing interests.', 'order': 3, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}], 'article-number': '484'}
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