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All Studies   Meta Analysis    Recent:   

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

Gershengorn et al., PLOS ONE, doi:10.1371/journal.pone.0278770
Dec 2022  
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Hospitalization, MV -95% Improvement Relative Risk Hospitalization, PSM -105% Hospitalization, delta -100% Hospitalization, omicron -111% Casirivimab/i..  Gershengorn et al.  EARLY TREATMENT Is early treatment with casirivimab/imdevimab beneficial for COVID-19? Retrospective 6,284 patients in the USA Higher hospitalization with casirivimab/imdevimab (not stat. sig., p=0.09) c19early.org Gershengorn et al., PLOS ONE, December 2022 Favorscasirivimab/im.. Favorscontrol 0 0.5 1 1.5 2+
17th treatment shown to reduce risk in March 2021
 
*, now with p = 0.00018 from 31 studies, recognized in 45 countries. Efficacy is variant dependent.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,800+ studies for 102 treatments. c19early.org
Retrospective 2,083 outpatients in the USA, showing higher risk of hospitalization with casirivimab/imdevimab, without statistical significance. There may be significant unadjusted confounding by indication.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for many omicron variants1-6.
This study is excluded in the after exclusion results of meta analysis: substantial unadjusted confounding by indication possible.
risk of hospitalization, 95.0% higher, OR 1.95, p = 0.09, treatment 369, control 5,915, adjusted per study, multivariable, day 30, RR approximated with OR.
risk of hospitalization, 104.9% higher, RR 2.05, p = 0.009, treatment 21 of 369 (5.7%), control 41 of 1,476 (2.8%), propensity score matching, day 30, Figure 2, PSM cohort.
risk of hospitalization, 100% higher, RR 2.00, p = 0.07, treatment 11 of 213 (5.2%), control 22 of 852 (2.6%), delta, propensity score matching, day 30, Figure 2, PSM cohort.
risk of hospitalization, 110.5% higher, RR 2.11, p = 0.06, treatment 10 of 156 (6.4%), control 19 of 624 (3.0%), omicron, propensity score matching, day 30, Figure 2, PSM cohort.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Gershengorn et al., 2 Dec 2022, retrospective, USA, peer-reviewed, 6 authors. Contact: hbg20@med.miami.edu, hsro@miami.edu.
This PaperCasirivimab/i..All
The clinical effectiveness of REGEN-COV in SARS-CoV-2 infection with Omicron versus Delta variants
Hayley B Gershengorn, Samira Patel, Tanira Ferreira, Sankalp Das, Dipen J Parekh, Bhavarth Shukla
PLOS ONE, doi:10.1371/journal.pone.0278770
Background 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. Methods and findings We conducted a retrospective cohort study of non-hospitalized adults who tested positive for SARS-CoV-2 by polymerase chain reaction at the
Supporting information S1 Table .
References
Brehm, Pfefferle, Possel, Karolyi, Zoufaly et al., Clinical efficacy and in vitro neutralization capacity of monoclonal antibodies for SARS-CoV-2 delta and omicron variants, J Med Virol, doi:10.1002/jmv.27916
Cao, Wang, Jian, Song, Yisimayi, Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies, Nature, doi:10.1038/s41586-021-04385-3
Chen, Winkler, Case, Aziati, Bricker et al., In vivo monoclonal antibody efficacy against SARS-CoV-2 variant strains, Nature, doi:10.1038/s41586-021-03720-y
Deyo, Cherkin, Ciol, Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases, J Clin Epidemiol, doi:10.1016/0895-4356%2892%2990133-8
Falcone, Tiseo, Valoriani, Barbieri, Occhineri et al., Efficacy of Bamlanivimab/ Etesevimab and Casirivimab/Imdevimab in Preventing Progression to Severe COVID-19 and Role of Variants of Concern, Infect Dis Ther, doi:10.1007/s40121-021-00525-4
Hachmann, Miller, Collier, Ventura, Yu et al., Neutralization Escape by SARS-CoV-2 Omicron Subvariants BA.2.12.1, BA.4, and BA.5, N Engl J Med, doi:10.1056/NEJMc2206576
Keating, Dong, Meko, Visualizing the omicron wave striking and rolling across the country, The Washington Post
Lusvarghi, Pollett, Neerukonda, Wang, Vassell, SARS-CoV-2 BA.1 variant is neutralized by vaccine booster-elicited serum but evades most convalescent serum and therapeutic antibodies, Sci Transl Med, doi:10.1126/scitranslmed.abn8543
Shaughnessy, Emergency Use Authorization 091
Tao, Tzou, Pond, Ioannidis, Shafer, Susceptibility of SARS-CoV-2 Omicron Variants to Therapeutic Monoclonal Antibodies: Systematic Review and Meta-analysis, Microbiol Spectr, doi:10.1128/spectrum.00926-22
Vanblargan, Errico, Halfmann, Zost, Crowe et al., An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by therapeutic monoclonal antibodies, Nat Med, doi:10.1038/s41591-021-01678-y
Ward, Bermingham, Ayoubkhani, Gethings, Pouwels et al., Risk of covid-19 related deaths for SARS-CoV-2 omicron (B.1.1.529) compared with delta (B.1.617.2): retrospective cohort study, BMJ, doi:10.1136/bmj-2022-070695
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
{ '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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'article-title': 'REGEN-COV Antibody Combination and Outcomes in Outpatients with ' 'Covid-19', 'volume': '385', 'author': 'DM Weinreich', 'year': '2021', 'journal-title': 'N Engl J Med'}, { 'issue': '645', 'key': 'pone.0278770.ref003', 'doi-asserted-by': 'crossref', 'first-page': 'eabn8543', 'DOI': '10.1126/scitranslmed.abn8543', 'article-title': 'SARS-CoV-2 BA.1 variant is neutralized by vaccine booster-elicited ' 'serum but evades most convalescent serum and therapeutic antibodies', 'volume': '14', 'author': 'S Lusvarghi', 'year': '2022', 'journal-title': 'Sci Transl Med'}, { 'issue': '3', 'key': 'pone.0278770.ref004', 'doi-asserted-by': 'crossref', 'first-page': '490', 'DOI': '10.1038/s41591-021-01678-y', 'article-title': 'An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization ' 'by therapeutic monoclonal antibodies', 'volume': '28', 'author': 'LA VanBlargan', 'year': '2022', 'journal-title': 'Nat Med'}, { 'issue': '7898', 'key': 'pone.0278770.ref005', 'doi-asserted-by': 'crossref', 'first-page': '657', 'DOI': '10.1038/s41586-021-04385-3', 'article-title': 'Omicron escapes the majority of existing SARS-CoV-2 neutralizing ' 'antibodies', 'volume': '602', 'author': 'Y Cao', 'year': '2022', 'journal-title': 'Nature'}, { 'key': 'pone.0278770.ref006', 'article-title': 'Clinical efficacy and in vitro neutralization capacity of monoclonal ' 'antibodies for SARS-CoV-2 delta and omicron variants', 'author': 'TT Brehm', 'year': '2022', 'journal-title': 'J Med Virol'}, { 'key': 'pone.0278770.ref007', 'doi-asserted-by': 'crossref', 'first-page': 'e0092622', 'DOI': '10.1128/spectrum.00926-22', 'article-title': 'Susceptibility of SARS-CoV-2 Omicron Variants to Therapeutic Monoclonal ' 'Antibodies: Systematic Review and Meta-analysis.', 'author': 'K Tao', 'year': '2022', 'journal-title': 'Microbiol Spectr.'}, { 'key': 'pone.0278770.ref008', 'first-page': '2022', 'article-title': 'Visualizing the omicron wave striking and rolling across the country.', 'volume': '28', 'author': 'D Keating', 'year': '2022', 'journal-title': 'The Washington Post.'}, { 'issue': '6', 'key': 'pone.0278770.ref009', 'doi-asserted-by': 'crossref', 'first-page': '613', 'DOI': '10.1016/0895-4356(92)90133-8', 'article-title': 'Adapting a clinical comorbidity index for use with ICD-9-CM ' 'administrative databases.', 'volume': '45', 'author': 'RA Deyo', 'year': '1992', 'journal-title': 'J Clin Epidemiol'}, { 'issue': '7870', 'key': 'pone.0278770.ref010', 'doi-asserted-by': 'crossref', 'first-page': '103', 'DOI': '10.1038/s41586-021-03720-y', 'article-title': 'In vivo monoclonal antibody efficacy against SARS-CoV-2 variant strains', 'volume': '596', 'author': 'RE Chen', 'year': '2021', 'journal-title': 'Nature'}, { 'issue': '4', 'key': 'pone.0278770.ref011', 'doi-asserted-by': 'crossref', 'first-page': '2479', 'DOI': '10.1007/s40121-021-00525-4', 'article-title': 'Efficacy of Bamlanivimab/Etesevimab and Casirivimab/Imdevimab in ' 'Preventing 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