REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19
David M Weinreich, Sumathi Sivapalasingam, Thomas Norton, Shazia Ali, Haitao Gao, Rafia Bhore, Jing Xiao, Andrea T Hooper, Jennifer D Hamilton, Bret J Musser, Diana Rofail, Mohamed Hussein, Joseph Im, Dominique Y Atmodjo, Christina Perry, Cynthia Pan, Adnan Mahmood, Romana Hosain, John D Davis, Kenneth C Turner, Alina Baum, Christos A Kyratsous, Yunji Kim, Amanda Cook, Wendy Kampman, Lilia Roque-Guerrero, Gerard Acloque, Hessam Aazami, Kevin Cannon, J Abraham Simón-Campos, Joseph A Bocchini, Bari Kowal, A Thomas Dicioccio, Yuhwen Soo, Gregory P Geba, Neil Stahl, Leah Lipsich, Ned Braunstein, Gary Herman, George D Yancopoulos
New England Journal of Medicine, doi:10.1056/nejmoa2108163
BACKGROUND In the phase 1-2 portion of an adaptive trial, REGEN-COV, a combination of the monoclonal antibodies casirivimab and imdevimab, reduced the viral load and number of medical visits in patients with coronavirus disease 2019 (Covid-19). REGEN-COV has activity in vitro against current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern.
METHODS In the phase 3 portion of an adaptive trial, we randomly assigned outpatients with Covid-19 and risk factors for severe disease to receive various doses of intravenous REGEN-COV or placebo. Patients were followed through day 29. A prespecified hierarchical analysis was used to assess the end points of hospitalization or death and the time to resolution of symptoms. Safety was also evaluated.
RESULTS Covid-19-related hospitalization or death from any cause occurred in 18 of 1355 patients in the REGEN-COV 2400-mg group (1.3%) and in 62 of 1341 patients in the placebo group who underwent randomization concurrently (4.6%) (relative risk reduction [1 minus the relative risk], 71.3%; P<0.001); these outcomes occurred in 7 of 736 patients in the REGEN-COV 1200-mg group (1.0%) and in 24 of 748 patients in the placebo group who underwent randomization concurrently (3.2%) (relative risk reduction, 70.4%; P = 0.002). The median time to resolution of symptoms was 4 days shorter with each REGEN-COV dose than with placebo (10 days vs. 14 days; P<0.001 for both comparisons). REGEN-COV was efficacious across various subgroups, including patients who were SARS-CoV-2 serum antibody-positive at baseline. Both REGEN-COV doses reduced viral load faster than placebo; the least-squares mean difference in viral load from baseline through day 7 was −0.71 log 10 copies per milliliter (95% confidence interval [CI], −0.90 to −0.53) in the 1200-mg group and −0.86 log 10 copies per milliliter (95% CI, −1.00 to −0.72) in the 2400-mg group. Serious adverse events occurred more frequently in the placebo group (4.0%) than in the 1200-mg group (1.1%) and the 2400-mg group (1.3%); infusion-related reactions of grade 2 or higher occurred in less than 0.3% of the patients in all groups.
CONCLUSIONS REGEN-COV reduced the risk of Covid-19-related hospitalization or death from any cause, and it resolved symptoms and reduced the SARS-CoV-2 viral load more rapidly than placebo. (Funded by Regeneron Pharmaceuticals and others; ClinicalTrials .gov number, NCT04425629.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. A data sharing statement provided by the authors is available with the full text of this article at NEJM.org. We thank the trial participants; their families; the investigational site members involved in this trial (principal and subprincipal investigators, listed in the Supplementary Appendix); the Regeneron trial team (members listed in the Supplementary Appendix); the members of the independent data and safety monitoring committee; Brian Head, Ph.D., Caryn Trbovic, Ph.D., and S. Balachandra Dass, Ph.D., of Regeneron Pharmaceuticals for assistance with development of an earlier version of the manuscript; and Prime for assistance with the formatting and copy editing of an earlier version of the manuscript.
Appendix The authors' full names and academic degrees are as follows: David M. Weinreich
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'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Alina',
'family': 'Baum',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Christos A.',
'family': 'Kyratsous',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Yunji',
'family': 'Kim',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Amanda',
'family': 'Cook',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Wendy',
'family': 'Kampman',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Lilia',
'family': 'Roque-Guerrero',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Gerard',
'family': 'Acloque',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Hessam',
'family': 'Aazami',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Kevin',
'family': 'Cannon',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'J. Abraham',
'family': 'Simón-Campos',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Joseph A.',
'family': 'Bocchini',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Bari',
'family': 'Kowal',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'A. Thomas',
'family': 'DiCioccio',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Yuhwen',
'family': 'Soo',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Gregory P.',
'family': 'Geba',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Neil',
'family': 'Stahl',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Leah',
'family': 'Lipsich',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Ned',
'family': 'Braunstein',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'Gary',
'family': 'Herman',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]},
{ 'given': 'George D.',
'family': 'Yancopoulos',
'sequence': 'additional',
'affiliation': [ { 'name': 'From Regeneron Pharmaceuticals, Tarrytown (D.M.W., T.N., S.A., '
'H.G., R.B., J.X., A.T.H., J.D.H., B.J.M., D.R., M.H., J.I., '
'D.Y.A., C. Perry, C. Pan, A.M., R.H., J.D.D., K.C.T., A.B., '
'C.A.K., Y.K., A.C., W.K., B.K., A.T.D., Y. S., G.P.G., N.S., '
'L.L., N.B., G.H., G.D.Y.) and Excision BioTherapeutics, New York '
'(S.S.) — both in New York; Bio-Medical Research (L.R.-G.) and '
'Universal Medical and Research Center (G.A.) — both in Miami; '
'Hope Clinical Research, Canoga Park, CA (H.A.); PMG Research of '
'Wilmington,...'}]}],
'member': '150',
'reference': [ { 'key': 'r3',
'first-page': '1775',
'volume': '323',
'author': 'Onder G',
'year': '2020',
'journal-title': 'JAMA'},
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'container-title': 'New England Journal of Medicine',
'original-title': [],
'language': 'en',
'link': [ { 'URL': 'http://www.nejm.org/doi/pdf/10.1056/NEJMoa2108163',
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'deposited': { 'date-parts': [[2022, 10, 20]],
'date-time': '2022-10-20T18:07:05Z',
'timestamp': 1666289225000},
'score': 1,
'resource': {'primary': {'URL': 'http://www.nejm.org/doi/10.1056/NEJMoa2108163'}},
'subtitle': [],
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'issued': {'date-parts': [[2021, 12, 2]]},
'references-count': 17,
'journal-issue': {'issue': '23', 'published-print': {'date-parts': [[2021, 12, 2]]}},
'alternative-id': ['10.1056/NEJMoa2108163'],
'URL': 'http://dx.doi.org/10.1056/NEJMoa2108163',
'relation': { 'has-preprint': [ { 'id-type': 'doi',
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