• N. Engl. J. Med. · Sep 2021

    Randomized Controlled Trial

    Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19.

    • Meagan P O'Brien, Eduardo Forleo-Neto, Bret J Musser, Flonza Isa, Kuo-Chen Chan, Neena Sarkar, Katharine J Bar, Ruanne V Barnabas, Dan H Barouch, Myron S Cohen, Christopher B Hurt, Dale R Burwen, Mary A Marovich, Peijie Hou, Ingeborg Heirman, John D Davis, Kenneth C Turner, Divya Ramesh, Adnan Mahmood, Andrea T Hooper, Jennifer D Hamilton, Yunji Kim, Lisa A Purcell, Alina Baum, Christos A Kyratsous, James Krainson, Richard Perez-Perez, Rizwana Mohseni, Bari Kowal, A Thomas DiCioccio, Neil Stahl, Leah Lipsich, Ned Braunstein, Gary Herman, George D Yancopoulos, David M Weinreich, and Covid-19 Phase 3 Prevention Trial Team.
    • From Regeneron Pharmaceuticals, Tarrytown, NY (M.P.O., E.F.-N., B.J.M., F.I., K.-C.C., N. Sarkar, P.H., I.H., J.D.D., K.C.T., D.R., A.M., A.T.H., J.D.H., Y.K., L.A.P., A.B., C.A.K., B.K., A.T.D., N. Stahl, L.L., N.B., G.H., G.D.Y., D.M.W.); the Departments of Medicine and Microbiology, University of Pennsylvania, Philadelphia (K.J.B.); the Departments of Global Health and Epidemiology and the Division of Allergy and Infectious Diseases, University of Washington, and the Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center - both in Seattle (R.V.B.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (D.H.B.); the Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., C.B.H.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (D.R.B., M.A.M.); Clinical Trials of Florida (J.K.) and Medical Research of Westchester (R.P.-P.) - both in Miami; and the Catalina Research Institute, Montclair, CA (R.M.).
    • N. Engl. J. Med. 2021 Sep 23; 385 (13): 118411951184-1195.

    BackgroundREGEN-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.MethodsWe 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).ResultsSymptomatic 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.ConclusionsSubcutaneous 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.).Copyright © 2021 Massachusetts Medical Society.

      Pubmed     Free full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…

Want more great medical articles?

Keep up to date with a free trial of metajournal, personalized for your practice.
1,624,503 articles already indexed!

We guarantee your privacy. Your email address will not be shared.