Clinical efficacy of casirivimab and imdevimab in preventing COVID-19 in the Omicron BA.5 subvariant epidemic: a retrospective study

DOI record: { "DOI": "10.21203/rs.3.rs-6582593/v1", "URL": "http://dx.doi.org/10.21203/rs.3.rs-6582593/v1", "abstract": "<title>Abstract</title>\n <p><bold>Background:</bold> The neutralizing monoclonal antibody combination of casirivimab and imdevimab (CAS + IMD) is the only therapy approved for preventing coronavirus disease 2019 (COVID-19) following exposure to severe acute respiratory syndrome coronavirus 2. However, the efficacy of CAS + IMD against Omicron variants remains uncertain, with <italic>in vitro</italic> studies indicating reduced neutralizing activity. This study aimed to evaluate the clinical efficacy of CAS + IMD in preventing COVID-19 among uninfected hospitalized contacts of patients with COVID-19.\n<bold>Methods:</bold> A retrospective chart review was conducted on 154 inpatients exposed to patients with COVID-19 between October and December 2022. Fifty-two uninfected participants who were unvaccinated or immunosuppressed and had risk factors for severe COVID-19 were included. The primary endpoint was the COVID-19 incidence rate. Statistical analyses included the chi-square test, Fisher's exact test, and Mann–Whitney U test, as appropriate. Factors associated with COVID-19 incidence (<italic>p</italic> &lt; 0.02) in univariate analysis were included in the multivariate logistic regression. Statistical significance was set at <italic>p</italic> &lt; 0.05.\n<bold>Results:</bold> Among the 52 participants, 14 and 38 were included in the CAS + IMD and non-CAS + IMD groups, respectively. The COVID-19 incidence rate was significantly lower in the CAS + IMD group than in the non-CAS + IMD group (14.3% vs. 52.6%, <italic>p</italic> = 0.013). Multivariate analysis identified CAS + IMD administration as significantly associated with reduced COVID-19 incidence (adjusted odds ratio [OR], 0.121; 95% confidence interval [CI], 0.020–0.710; <italic>p</italic> = 0.019), whereas long-term use of immunosuppressive therapy was associated with increased incidence (adjusted OR, 4.320; 95% CI, 1.090–17.126; <italic>p</italic> = 0.037).\n<bold>Conclusions:</bold> CAS + IMD may be effective for post-exposure prophylaxis of COVID-19 during the Omicron BA.5 subvariant epidemic. However, prudent clinical use should consider the circulating variant profile. Further research is warranted to validate CAS + IMD’s role in COVID-19 post-exposure prophylaxis.</p>", "accepted": { "date-parts": [ [ 2025, 5, 3 ] ] }, "author": [ { "affiliation": [ { "name": "Toho University Omori Medical Center" } ], "family": "Ohtani", "given": "Mariko", "sequence": "first" }, { "affiliation": [ { "name": "Toho University Omori Medical Center" } ], "family": "Yokoo", "given": "Takuya", "sequence": "additional" }, { "affiliation": [ { "name": "Toho University Omori Medical Center" } ], "family": "Miyazaki", "given": "Taito", "sequence": "additional" }, { "affiliation": [ { "name": "Toho University Omori Medical Center" } ], "family": "Yasuda", "given": "Hiroshi", "sequence": "additional" }, { "affiliation": [ { "name": "Toho University Omori Medical Center" } ], "family": "Nishikawa", "given": "Eriko", "sequence": "additional" }, { "affiliation": [ { "name": "Toho University Omori Medical Center" } ], "family": "Tomida", "given": "Manabu", "sequence": "additional" }, { "affiliation": [ { "name": "Toho University Omori Medical Center" } ], "family": "Tsukada", "given": "Mayumi", "sequence": "additional" }, { "affiliation": [ { "name": "Toho University Omori Medical Center" } ], "family": "Sato", "given": "Emi", "sequence": "additional" }, { "affiliation": [ { "name": "Toho University Omori Medical Center" } ], "family": "Hirayama", "given": "Shinobu", "sequence": "additional" }, { "affiliation": [ { "name": "Toho University Omori Medical Center" } ], "family": "Murakami", "given": "Hinako", "sequence": "additional" }, { "affiliation": [ { "name": "Toho University Omori Medical Center" } ], "family": "Yoshizawa", "given": "Sadako", "sequence": "additional" }, { "affiliation": [ { "name": "Toho University Omori Medical Center" } ], "family": "Matsumoto", "given": "Takahiro", "sequence": "additional" }, { "affiliation": [ { "name": "Toho University Omori Medical Center" } ], "family": "Tateda", "given": "Kazuhiro", "sequence": "additional" } ], "container-title": [], "content-domain": { "crossmark-restriction": false, "domain": [] }, "created": { "date-parts": [ [ 2025, 5, 13 ] ], "date-time": "2025-05-13T09:51:46Z", "timestamp": 1747129906000 }, "deposited": { "date-parts": [ [ 2025, 5, 13 ] ], "date-time": "2025-05-13T09:51:47Z", "timestamp": 1747129907000 }, "group-title": "In Review", "indexed": { "date-parts": [ [ 2025, 5, 14 ] ], "date-time": "2025-05-14T04:14:22Z", "timestamp": 1747196062260, "version": "3.40.5" }, "institution": [ { "name": "Research Square" } ], "is-referenced-by-count": 0, "issued": { "date-parts": [ [ 2025, 5, 13 ] ] }, "license": [ { "URL": "https://creativecommons.org/licenses/by/4.0/", "content-version": "unspecified", "delay-in-days": 0, "start": { "date-parts": [ [ 2025, 5, 13 ] ], "date-time": "2025-05-13T00:00:00Z", "timestamp": 1747094400000 } } ], "link": [ { "URL": "https://www.researchsquare.com/article/rs-6582593/v1", "content-type": "text/html", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://www.researchsquare.com/article/rs-6582593/v1.html", "content-type": "unspecified", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "297", "original-title": [], "posted": { "date-parts": [ [ 2025, 5, 13 ] ] }, "prefix": "10.21203", "published": { "date-parts": [ [ 2025, 5, 13 ] ] }, "publisher": "Springer Science and Business Media LLC", "reference": [ { "DOI": "10.1038/s41579-022-00841-7", "article-title": "SARS-CoV-2 variant biology: immune escape, transmission and fitness", "author": "Carabelli AM", "doi-asserted-by": "publisher", "first-page": "162", "issue": "3", "journal-title": "Nat Rev Microbiol", "key": "ref1", "unstructured": "Carabelli AM, Peacock TP, Thorne LG, Harvey WT, Hughes J, de Silva TI, et al. 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