REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19
Open accessAbstract
BACKGROUND: Recent data suggest that complications and death from coronavirus disease 2019 (Covid-19) may be related to high viral loads. METHODS: In this ongoing, double-blind, phase 1-3 trial involving nonhospitalized patients with Covid-19, we investigated two fully human, neutralizing monoclonal antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, used in a combined cocktail (REGN-COV2) to reduce the risk of the emergence of treatment-resistant mutant virus. Patients were randomly assigned (1:1:1) to receive placebo, 2.4 g of REGN-COV2, or 8.0 g of REGN-COV2 and were prospectively characterized at baseline for endogenous immune response against SARS-CoV-2 (serum antibody-positive or serum antibody-negative). Key end points included the time-weighted average change in viral load from baseline (day 1) through day 7 and the percentage of patients with at least one Covid-19-related medically attended visit through day 29. Safety was assessed in all patients. RESULTS: copies per milliliter (95% CI, -0.71 to -0.10) in the overall trial population. In the overall trial population, 6% of the patients in the placebo group and 3% of the patients in the combined REGN-COV2 dose groups reported at least one medically attended visit; among patients who were serum antibody-negative at baseline, the corresponding percentages were 15% and 6% (difference, -9 percentage points; 95% CI, -29 to 11). The percentages of patients with hypersensitivity reactions, infusion-related reactions, and other adverse events were similar in the combined REGN-COV2 dose groups and the placebo group. CONCLUSIONS: In this interim analysis, the REGN-COV2 antibody cocktail reduced viral load, with a greater effect in patients whose immune response had not yet been initiated or who had a high viral load at baseline. Safety outcomes were similar in the combined REGN-COV2 dose groups and the placebo group. (Funded by Regeneron Pharmaceuticals and the Biomedical and Advanced Research and Development Authority of the Department of Health and Human Services; ClinicalTrials.gov number, NCT04425629.).
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Administration of SARS-CoV-2-specific monoclonal antibodies within the first week of symptoms in mild-to-moderate infection seems to accelerate viral clearance and reduce risk of clinical progression.
“Evidence for this comes from studies involving the administration of SARS-CoV-2-specific monoclonal antibodies within the first week of symptoms in mild-to-moderate SARS-CoV-2 infection, which seems to accelerate the clearance of virus and reduce the risk of clinical progression36,37.”
From Prospects for durable immune control of SARS-CoV-2 and prevention of reinfection (2021) · cites this paper as [36]
The effect of monoclonal antibodies was dose dependent and greater in patients lacking endogenous antibody responses.
“This effect was dose dependent and was greater for those patients who lacked endogenous antibody responses.”
From Prospects for durable immune control of SARS-CoV-2 and prevention of reinfection (2021) · cites this paper as [36]
Cocktails of casirivimab and imdevimab and of etesevimab and bamlanivimab are currently used for COVID-19 therapy.
“cocktails of casirivimab and imdevimab (REGN-COV2, Regeneron) (Weinreich et al., 2021) and etesevimab and bamlanivimab (Eli Lilly) (Dougan et al., 2021) are currently used for COVID-19 therapy”
From The Omicron variant is highly resistant against antibody-mediated neutralization: Implications for control of the COVID-19 pandemic (2022) · cites this paper as Weinreich et al., 2021
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- Authors
- Weinreich, D. M., Sivapalasingam, S., Norton, T., Ali, S., Gao, H., Bhore, R., Musser, B. J., Soo, Y., Rofail, D., Im, J., Perry, C., Pan, C., Hosain, R., Mahmood, A., Davis, J. D., Turner, K. C., Hooper, A. T., Hamilton, J. D., Baum, A., Kyratsous, C. A., Kim, Y., Cook, A., Kampman, W., Kohli, A., Sachdeva, Y., Graber, X., Kowal, B., DiCioccio, T., Stahl, N., Lipsich, L., Braunstein, N., Herman, G., & Yancopoulos, G. D.
- Affiliations
- Regeneron (United States) (US)
- From Regeneron Pharmaceuticals, Tarrytown, NY (D.M.W., S.S., T.N., S.A., H.G., R.B., B.J.M., Y. Soo, D.R., J.I., C. Perry, C. Pan, R.H., A.M., J.D.D., K.C.T., A.T.H., J.D.H., A.B., C.A.K., Y.K., A.C., W.K., B.K., T.D., N.S., L.L., N.B., G.H., G.D.Y.); Arizona Liver Health, Tucson (A.K.), and Arizona Liver Health, Chandler (Y. Sachdeva); and AGA Clinical Trials, Hialeah, FL (X.G.).
- Corresponding author
- Weinreich, David M.
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-01-21
- Volume
- 384
- Issue
- 3
- Pages
- 238-251
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC7781102
- OpenAlex
- W3111431752
- Cited by
- 1,642
- References
- 23
- Citations by year
- 2026: 31 · 2025: 64 · 2024: 110 · 2023: 233 · 2022: 551 · 2021: 645 · 2020: 6
- FWCI
- 47.07
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- New England Journal of Medicine (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Department of Health and Human Services (HHSO100201700020C)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Keywords
- neutralizing monoclonal antibodies, SARS-CoV-2, COVID-19 pandemic, viral load, outpatients, SARS-CoV-2 spike protein, hypersensitivity, infusion reactions
- MeSH terms
- COVID-19, SARS-CoV-2, COVID-19 Drug Treatment, Adult, Double-Blind Method, Drug Combinations, Female, Humans, Immunologic Factors, Male, Middle Aged, Outpatients, Least-Squares Analysis, Viral Load, Reverse Transcriptase Polymerase Chain Reaction, Antibodies, Neutralizing, Antibodies, Monoclonal, Humanized
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