Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19
Copyright © 2021 Massachusetts Medical Society..
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 (>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. (Funded by Regeneron Pharmaceuticals and others; ClinicalTrials.gov number, NCT04452318.).
| Errataetall: | |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:385 |
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| Enthalten in: |
The New England journal of medicine - 385(2021), 13 vom: 23. Sept., Seite 1184-1195 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
O'Brien, Meagan P [VerfasserIn] |
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| Links: |
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| Themen: |
Antibodies, Monoclonal, Humanized |
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| Anmerkungen: |
Date Completed 12.10.2021 Date Revised 02.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT04452318 UpdateOf: medRxiv. 2021 Jun 17;:. - PMID 34159344 Citation Status MEDLINE |
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| doi: |
10.1056/NEJMoa2109682 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19 |
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| 500 | |a Date Completed 12.10.2021 | ||
| 500 | |a Date Revised 02.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04452318 | ||
| 500 | |a UpdateOf: medRxiv. 2021 Jun 17;:. - PMID 34159344 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2021 Massachusetts Medical Society. | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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.) | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 650 | 7 | |a Drug Combinations |2 NLM | |
| 650 | 7 | |a casirivimab and imdevimab drug combination |2 NLM | |
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| 700 | 1 | |a Musser, Bret J |e verfasserin |4 aut | |
| 700 | 1 | |a Isa, Flonza |e verfasserin |4 aut | |
| 700 | 1 | |a Chan, Kuo-Chen |e verfasserin |4 aut | |
| 700 | 1 | |a Sarkar, Neena |e verfasserin |4 aut | |
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| 700 | 1 | |a Hurt, Christopher B |e verfasserin |4 aut | |
| 700 | 1 | |a Burwen, Dale R |e verfasserin |4 aut | |
| 700 | 1 | |a Marovich, Mary A |e verfasserin |4 aut | |
| 700 | 1 | |a Hou, Peijie |e verfasserin |4 aut | |
| 700 | 1 | |a Heirman, Ingeborg |e verfasserin |4 aut | |
| 700 | 1 | |a Davis, John D |e verfasserin |4 aut | |
| 700 | 1 | |a Turner, Kenneth C |e verfasserin |4 aut | |
| 700 | 1 | |a Ramesh, Divya |e verfasserin |4 aut | |
| 700 | 1 | |a Mahmood, Adnan |e verfasserin |4 aut | |
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| 700 | 1 | |a Hamilton, Jennifer D |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Yunji |e verfasserin |4 aut | |
| 700 | 1 | |a Purcell, Lisa A |e verfasserin |4 aut | |
| 700 | 1 | |a Baum, Alina |e verfasserin |4 aut | |
| 700 | 1 | |a Kyratsous, Christos A |e verfasserin |4 aut | |
| 700 | 1 | |a Krainson, James |e verfasserin |4 aut | |
| 700 | 1 | |a Perez-Perez, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Mohseni, Rizwana |e verfasserin |4 aut | |
| 700 | 1 | |a Kowal, Bari |e verfasserin |4 aut | |
| 700 | 1 | |a DiCioccio, A Thomas |e verfasserin |4 aut | |
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| 700 | 1 | |a Lipsich, Leah |e verfasserin |4 aut | |
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| 700 | 1 | |a Yancopoulos, George D |e verfasserin |4 aut | |
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| 700 | 0 | |a Covid-19 Phase 3 Prevention Trial Team |e verfasserin |4 aut | |
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| 700 | 1 | |a Sachdeva, Yessica |e investigator |4 oth | |
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| 700 | 1 | |a Sutton, David |e investigator |4 oth | |
| 700 | 1 | |a Pereira, Edward |e investigator |4 oth | |
| 700 | 1 | |a Gloria, Rodel |e investigator |4 oth | |
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