Dataset Information

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

ABSTRACT:

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 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<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).

Conclusions

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.

SUBMITTER: Gershengorn HB

PROVIDER: S-EPMC9718412 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

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

Gershengorn Hayley B HB Patel Samira S Ferreira Tanira T Das Sankalp S Parekh Dipen J DJ Shukla Bhavarth B

PloS one 20221202 12

<h4>Background</h4>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.<h4>Methods and findings</h4>We conducted a retrospective cohort study of non-hospitalized adults who tested positive for SARS-CoV- ...[more]

PMID: 36459537

Similar Datasets

Project description:BackgroundThe continuous emergence of SARS-CoV-2 variants of concern (VOC) with immune escape properties, such as Delta (B.1.617.2) and Omicron (B.1.1.529), questions the extent of the antibody-mediated protection against the virus. Here we investigated the long-term antibody persistence in previously infected subjects and the extent of the antibody-mediated protection against B.1, B.1.617.2 and BA.1 variants in unvaccinated subjects previously infected, vaccinated naïve and vaccinated previously infected subjects.MethodsBlood samples collected 15 months post-infection from unvaccinated (n=35) and vaccinated (n=41) previously infected subjects (Vo' cohort) were tested for the presence of antibodies against the SARS-CoV-2 spike (S) and nucleocapsid (N) antigens using the Abbott, DiaSorin, and Roche immunoassays. The serum neutralising reactivity was assessed against B.1, B.1.617.2 (Delta), and BA.1 (Omicron) SARS-CoV-2 strains through micro-neutralisation. The antibody titres were compared to those from previous timepoints, performed at 2- and 9-months post-infection on the same individuals. Two groups of naïve subjects were used as controls, one from the same cohort (unvaccinated n=29 and vaccinated n=20) and a group of vaccinated naïve healthcare workers (n=61).ResultsWe report on the results of the third serosurvey run in the Vo' cohort. With respect to the 9-month time point, antibodies against the S antigen significantly decreased (P=0.0063) among unvaccinated subjects and increased (P<0.0001) in vaccinated individuals, whereas those against the N antigen decreased in the whole cohort. When compared with control groups (naïve Vo' inhabitants and naïve healthcare workers), vaccinated subjects that were previously infected had higher antibody levels (P<0.0001) than vaccinated naïve subjects. Two doses of vaccine elicited stronger anti-S antibody response than natural infection (P<0.0001). Finally, the neutralising reactivity of sera against B.1.617.2 and BA.1 was 4-fold and 16-fold lower than the reactivity observed against the original B.1 strain.ConclusionsThese results confirm that vaccination induces strong antibody response in most individuals, and even stronger in previously infected subjects. Neutralising reactivity elicited by natural infection followed by vaccination is increasingly weakened by the recent emergence of VOCs. While immunity is not completely compromised, a change in vaccine development may be required going forward, to generate cross-protective pan-coronavirus immunity in the global population.

Dataset Information

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

Background

Methods and findings

Conclusions

Publications

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

Similar Datasets

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