tetano
Editor, Senior Moderator
N Engl J Med
. 2021 Aug 4.
doi: 10.1056/NEJMoa2109682. Online ahead of print.
Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19
Meagan P O'Brien[SUP] 1 [/SUP], Eduardo Forleo-Neto[SUP] 1 [/SUP], Bret J Musser[SUP] 1 [/SUP], Flonza Isa[SUP] 1 [/SUP], Kuo-Chen Chan[SUP] 1 [/SUP], Neena Sarkar[SUP] 1 [/SUP], Katharine J Bar[SUP] 1 [/SUP], Ruanne V Barnabas[SUP] 1 [/SUP], Dan H Barouch[SUP] 1 [/SUP], Myron S Cohen[SUP] 1 [/SUP], Christopher B Hurt[SUP] 1 [/SUP], Dale R Burwen[SUP] 1 [/SUP], Mary A Marovich[SUP] 1 [/SUP], Peijie Hou[SUP] 1 [/SUP], Ingeborg Heirman[SUP] 1 [/SUP], John D Davis[SUP] 1 [/SUP], Kenneth C Turner[SUP] 1 [/SUP], Divya Ramesh[SUP] 1 [/SUP], Adnan Mahmood[SUP] 1 [/SUP], Andrea T Hooper[SUP] 1 [/SUP], Jennifer D Hamilton[SUP] 1 [/SUP], Yunji Kim[SUP] 1 [/SUP], Lisa A Purcell[SUP] 1 [/SUP], Alina Baum[SUP] 1 [/SUP], Christos A Kyratsous[SUP] 1 [/SUP], James Krainson[SUP] 1 [/SUP], Richard Perez-Perez[SUP] 1 [/SUP], Rizwana Mohseni[SUP] 1 [/SUP], Bari Kowal[SUP] 1 [/SUP], A Thomas DiCioccio[SUP] 1 [/SUP], Neil Stahl[SUP] 1 [/SUP], Leah Lipsich[SUP] 1 [/SUP], Ned Braunstein[SUP] 1 [/SUP], Gary Herman[SUP] 1 [/SUP], George D Yancopoulos[SUP] 1 [/SUP], David M Weinreich[SUP] 1 [/SUP], Covid-19 Phase 3 Prevention Trial Team
Affiliations
Abstract
Background: REGEN-COV (previously known as REGN-COV2), a combination of the monoclonal antibodies casirivimab and imdevimab, has been shown to markedly reduce the risk of hospitalization or death among high-risk persons with coronavirus disease 2019 (Covid-19). Whether subcutaneous REGEN-COV prevents severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and subsequent Covid-19 in persons at high risk for infection because of household exposure to a person with SARS-CoV-2 infection is unknown.
Methods: We randomly assigned, in a 1:1 ratio, participants (≥12 years of age) who were enrolled within 96 hours after a household contact received a diagnosis of SARS-CoV-2 infection to receive a total dose of 1200 mg of REGEN-COV or matching placebo administered by means of subcutaneous injection. At the time of randomization, participants were stratified according to the results of the local diagnostic assay for SARS-CoV-2 and according to age. The primary efficacy end point was the development of symptomatic SARS-CoV-2 infection through day 28 in participants who did not have SARS-COV-2 infection (as measured by reverse-transcriptase-quantitative polymerase-chain-reaction assay) or previous immunity (seronegativity).
Results: Symptomatic SARS-CoV-2 infection developed in 11 of 753 participants in the REGEN-COV group (1.5%) and in 59 of 752 participants in the placebo group (7.8%) (relative risk reduction [1 minus the relative risk], 81.4%; P<0.001). In weeks 2 to 4, a total of 2 of 753 participants in the REGEN-COV group (0.3%) and 27 of 752 participants in the placebo group (3.6%) had symptomatic SARS-CoV-2 infection (relative risk reduction, 92.6%). REGEN-COV also prevented symptomatic and asymptomatic infections overall (relative risk reduction, 66.4%). Among symptomatic infected participants, the median time to resolution of symptoms was 2 weeks shorter with REGEN-COV than with placebo (1.2 weeks and 3.2 weeks, respectively), and the duration of a high viral load (>10[SUP]4[/SUP] copies per milliliter) was shorter (0.4 weeks and 1.3 weeks, respectively). No dose-limiting toxic effects of REGEN-COV were noted.
Conclusions: Subcutaneous REGEN-COV prevented symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection in previously uninfected household contacts of infected persons. Among the participants who became infected, REGEN-COV reduced the duration of symptomatic disease and the duration of a high viral load. (Funded by Regeneron Pharmaceuticals and others; ClinicalTrials.gov number, NCT04452318.).
. 2021 Aug 4.
doi: 10.1056/NEJMoa2109682. Online ahead of print.
Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19
Meagan P O'Brien[SUP] 1 [/SUP], Eduardo Forleo-Neto[SUP] 1 [/SUP], Bret J Musser[SUP] 1 [/SUP], Flonza Isa[SUP] 1 [/SUP], Kuo-Chen Chan[SUP] 1 [/SUP], Neena Sarkar[SUP] 1 [/SUP], Katharine J Bar[SUP] 1 [/SUP], Ruanne V Barnabas[SUP] 1 [/SUP], Dan H Barouch[SUP] 1 [/SUP], Myron S Cohen[SUP] 1 [/SUP], Christopher B Hurt[SUP] 1 [/SUP], Dale R Burwen[SUP] 1 [/SUP], Mary A Marovich[SUP] 1 [/SUP], Peijie Hou[SUP] 1 [/SUP], Ingeborg Heirman[SUP] 1 [/SUP], John D Davis[SUP] 1 [/SUP], Kenneth C Turner[SUP] 1 [/SUP], Divya Ramesh[SUP] 1 [/SUP], Adnan Mahmood[SUP] 1 [/SUP], Andrea T Hooper[SUP] 1 [/SUP], Jennifer D Hamilton[SUP] 1 [/SUP], Yunji Kim[SUP] 1 [/SUP], Lisa A Purcell[SUP] 1 [/SUP], Alina Baum[SUP] 1 [/SUP], Christos A Kyratsous[SUP] 1 [/SUP], James Krainson[SUP] 1 [/SUP], Richard Perez-Perez[SUP] 1 [/SUP], Rizwana Mohseni[SUP] 1 [/SUP], Bari Kowal[SUP] 1 [/SUP], A Thomas DiCioccio[SUP] 1 [/SUP], Neil Stahl[SUP] 1 [/SUP], Leah Lipsich[SUP] 1 [/SUP], Ned Braunstein[SUP] 1 [/SUP], Gary Herman[SUP] 1 [/SUP], George D Yancopoulos[SUP] 1 [/SUP], David M Weinreich[SUP] 1 [/SUP], Covid-19 Phase 3 Prevention Trial Team
Affiliations
- PMID: 34347950
- DOI: 10.1056/NEJMoa2109682
Abstract
Background: REGEN-COV (previously known as REGN-COV2), a combination of the monoclonal antibodies casirivimab and imdevimab, has been shown to markedly reduce the risk of hospitalization or death among high-risk persons with coronavirus disease 2019 (Covid-19). Whether subcutaneous REGEN-COV prevents severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and subsequent Covid-19 in persons at high risk for infection because of household exposure to a person with SARS-CoV-2 infection is unknown.
Methods: We randomly assigned, in a 1:1 ratio, participants (≥12 years of age) who were enrolled within 96 hours after a household contact received a diagnosis of SARS-CoV-2 infection to receive a total dose of 1200 mg of REGEN-COV or matching placebo administered by means of subcutaneous injection. At the time of randomization, participants were stratified according to the results of the local diagnostic assay for SARS-CoV-2 and according to age. The primary efficacy end point was the development of symptomatic SARS-CoV-2 infection through day 28 in participants who did not have SARS-COV-2 infection (as measured by reverse-transcriptase-quantitative polymerase-chain-reaction assay) or previous immunity (seronegativity).
Results: Symptomatic SARS-CoV-2 infection developed in 11 of 753 participants in the REGEN-COV group (1.5%) and in 59 of 752 participants in the placebo group (7.8%) (relative risk reduction [1 minus the relative risk], 81.4%; P<0.001). In weeks 2 to 4, a total of 2 of 753 participants in the REGEN-COV group (0.3%) and 27 of 752 participants in the placebo group (3.6%) had symptomatic SARS-CoV-2 infection (relative risk reduction, 92.6%). REGEN-COV also prevented symptomatic and asymptomatic infections overall (relative risk reduction, 66.4%). Among symptomatic infected participants, the median time to resolution of symptoms was 2 weeks shorter with REGEN-COV than with placebo (1.2 weeks and 3.2 weeks, respectively), and the duration of a high viral load (>10[SUP]4[/SUP] copies per milliliter) was shorter (0.4 weeks and 1.3 weeks, respectively). No dose-limiting toxic effects of REGEN-COV were noted.
Conclusions: Subcutaneous REGEN-COV prevented symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection in previously uninfected household contacts of infected persons. Among the participants who became infected, REGEN-COV reduced the duration of symptomatic disease and the duration of a high viral load. (Funded by Regeneron Pharmaceuticals and others; ClinicalTrials.gov number, NCT04452318.).