Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19

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  • O'Brien, M.P.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Forleo-Neto, E.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Musser, B.J.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Isa, F.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Chan, K.-C.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Sarkar, N.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Bar, K.J.
    • Other Affiliation: University of Pennsylvania
  • Barnabas, R.V.
    • Other Affiliation: University of Washington
  • Barouch, D.H.
    • Other Affiliation: Harvard Medical School
  • Cohen, M.S.
    • Affiliation: School of Medicine, Institute for Global Health and Infectious Diseases
  • Hurt, C.B.
    • Affiliation: School of Medicine, Institute for Global Health and Infectious Diseases
  • Burwen, D.R.
    • Other Affiliation: National Institutes of Health
  • Marovich, M.A.
    • Other Affiliation: National Institutes of Health
  • Hou, P.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Heirman, I.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Davis, J.D.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Turner, K.C.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Ramesh, D.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Mahmood, A.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Hooper, A.T.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Hamilton, J.D.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Kim, Y.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Purcell, L.A.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Baum, A.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Kyratsous, C.A.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Krainson, J.
    • Other Affiliation: Clinical Trials of Florida
  • Perez-Perez, R.
    • Other Affiliation: Medical Research of Westchester
  • Mohseni, R.
    • Other Affiliation: The Catalina Research Institute
  • Kowal, B.
    • Other Affiliation: Regeneron Pharmaceuticals
  • DiCioccio, A.T.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Stahl, N.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Lipsich, L.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Braunstein, N.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Herman, G.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Yancopoulos, G.D.
    • Other Affiliation: Regeneron Pharmaceuticals
  • Weinreich, D.M.
    • Other Affiliation: Regeneron Pharmaceuticals
  • the Covid-19 Phase 3 Prevention Trial Team
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 SARSCoV- 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 (>104 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.
Date of publication
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DOI
Identifier
Resource type
  • Article
Journal title
  • New England Journal of Medicine
Journal volume
  • 385
Journal issue
  • 13
Page start
  • 1184
Page end
  • 1195
Language
  • English
Funder
  • National Institute of Allergy and Infectious Diseases, NIAID: P30AI045008, UM1AI068619, UM1AI069534
  • National Institutes of Health, NIH
ISSN
  • 0028-4793
Publisher
  • Massachussetts Medical Society

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