The clinical effectiveness of REGEN-COV in SARS-CoV-2 infection with Omicron versus Delta variants

{ 'indexed': {'date-parts': [[2022, 12, 3]], 'date-time': '2022-12-03T06:03:37Z', 'timestamp': 1670047417289}, 'reference-count': 13, 'publisher': 'Public Library of Science (PLoS)', 'issue': '12', 'license': [ { 'start': { 'date-parts': [[2022, 12, 2]], 'date-time': '2022-12-02T00:00:00Z', 'timestamp': 1669939200000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'http://creativecommons.org/licenses/by/4.0/'}], 'funder': [ {'name': 'University of Miami Hospital and Clinics Data Analytics Research Team'}, {'name': 'University of Miami Hospital and Clinics Data Analytics Research Team'}, {'name': 'University of Miami Hospital and Clinics Data Analytics Research Team'}, {'name': 'University of Miami Hospital and Clinics Data Analytics Research Team'}, {'name': 'University of Miami Hospital and Clinics Data Analytics Research Team'}, {'name': 'University of Miami Hospital and Clinics Data Analytics Research Team'}], 'content-domain': {'domain': ['www.plosone.org'], 'crossmark-restriction': False}, 'abstract': '<jats:sec id="sec001">\n' '<jats:title>Background</jats:title>\n' '<jats:p>In vitro studies suggesting that REGEN-COV (casirivimab plus imdevimab monoclonal ' 'antibodies) had poor efficacy against Omicron-variant SARS-CoV-2 infection led to amendment ' 'of REGEN-COV’s Emergency Use Authorization to recommend use only in regions without high ' 'Omicron prevalence. REGEN-COV’s relative clinical effectiveness for Omicron is ' 'unknown.</jats:p>\n' '</jats:sec>\n' '<jats:sec id="sec002">\n' '<jats:title>Methods and findings</jats:title>\n' '<jats:p>We conducted a retrospective cohort study of non-hospitalized adults who tested ' 'positive for SARS-CoV-2 by polymerase chain reaction at the University of Miami Health System ' 'from July 19 –November 21, 2021 (Delta period) and December 6, 2021 –January 7, 2022 (Omicron ' 'period). Subjects were stratified be REGEN-COV receipt within 72h of test positivity and by ' 'time period of infection. We constructed multivariable logistic regression models to assess ' 'the differential association of REGEN-COV receipt with hospitalization within 30 days ' '(primary outcome) and ED presentation; all models included three exposure terms (REGEN-COV ' 'receipt, Omicron vs Delta period, interaction of REGEN-COV with time period) and potential ' 'confounders (vaccination status, vaccine boosting, cancer diagnosis). Our cohort consisted of ' '2,083 adults in the Delta period (213 [10.2%] received REGEN-COV) and 4,201 in the Omicron ' 'period (156 [3.7%] received REGEN-COV). Hospitalization was less common during the Omicron ' 'period than during Delta (0.9% vs 1.7%, p = 0.78) and more common for patients receiving ' 'REGEN-COV than not (5.7% vs 0.9%, p&lt;0.001). After adjustment, we found no differential ' 'association of REGEN-COV use during Omicron vs Delta with hospitalization within 30d ' '(adjusted odds ratio [95% confidence interval] for the interaction term: 2.31 [0.76–6.92], p ' '= 0.13). Similarly, we found no differential association for hospitalization within 15d (2.45 ' '[0.63–9.59], p = 0.20) or emergency department presentation within 30d (1.43 [0.57–3.51], p = ' '0.40) or within 15d (1.79 [0.65–4.82], p = 0.30).</jats:p>\n' '</jats:sec>\n' '<jats:sec id="sec003">\n' '<jats:title>Conclusions</jats:title>\n' '<jats:p>Within the limitations of this study’s power to detect a difference, we identified no ' 'differential effectiveness of REGEN-COV in the context of Omicron vs Delta SARS-CoV-2 ' 'infection.</jats:p>\n' '</jats:sec>', 'DOI': '10.1371/journal.pone.0278770', 'type': 'journal-article', 'created': {'date-parts': [[2022, 12, 2]], 'date-time': '2022-12-02T18:25:55Z', 'timestamp': 1670005555000}, 'page': 'e0278770', 'update-policy': 'http://dx.doi.org/10.1371/journal.pone.corrections_policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'The clinical effectiveness of REGEN-COV in SARS-CoV-2 infection with Omicron versus Delta ' 'variants', 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