The DOI matches its Crossref record; 19 of the 19 references it cites were found in a registry or an index.
REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19
Open accessAbstract
ABSTRACT Background REGEN-COV antibody cocktail (casirivimab with imdevimab) rapidly reduced viral load and decreased medically-attended visits in the phase 1/2 portion of this trial; REGEN-COV, retains activity in vitro against emerging SARS-CoV-2 variants of concern. Methods The phase 3 portion of this adaptive, randomized, master protocol, included 4,057 Covid-19 outpatients with one or more risk factors for severe disease. Patients were randomized to a single treatment of intravenous placebo, or various doses of REGEN-COV, and followed for 28 days. The prespecified hierarchical analysis first compared REGEN-COV 2400mg dose vs concurrent placebo, then compared the 1200mg dose vs concurrent placebo, for endpoints assessing risk of hospitalization or death, and time to symptom resolution. Safety was evaluated in all treated patients. Results Both REGEN-COV 2400mg and 1200mg significantly reduced Covid-19-related hospitalization or all-cause death compared to placebo (71.3% reduction [1.3% vs 4.6%; p<0.0001] and 70.4% reduction [1.0% vs 3.2%; p=0.0024], respectively). The median time to resolution of Covid-19 symptoms was 4 days shorter in both dose arms vs placebo (10 vs 14 days; p<0.0001). Efficacy of REGEN-COV was consistent across subgroups, including patients who were SARS-CoV-2 serum antibody-positive at baseline. REGEN-COV more rapidly reduced viral load than placebo. Serious adverse events occurred more frequently in the placebo group (4.0%) than in the 1200mg (1.1%) and 2400mg (1.3%) groups and grade ≥2 infusion-related reactions were infrequent (<0.3% in all groups). Conclusions Treatment with REGEN-COV was well-tolerated and significantly reduced Covid-19-related hospitalization or all-cause death, rapidly resolved symptoms, and reduced viral load. (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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Self-citationREGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19
Weinreich, D. M., Sivapalasingam, S., Norton, T., Ali, S., Gao, H., Bhore, R., Musser, B. J., Soo, Y., Rofail, D., Im, J., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2035002 · Cited by 1,642
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Agarwal, A., Hunt, B. J., Stegemann, M., Rochwerg, B., Lamontagne, F., Siemieniuk, R. A., Agoritsas, T., Askie, L., Lytvyn, L., Leo, Y.-S., et al. (2020) · BMJ · doi:10.1136/bmj.m3379 · Cited by 1,041
Self-citationThe biological and clinical significance of emerging SARS-CoV-2 variants
Tao, K., Tzou, P. L., Nouhin, J., Gupta, R. K., de Oliveira, T., Kosakovsky Pond, S. L., Fera, D., & Shafer, R. W. (2021) · Nature Reviews Genetics · doi:10.1038/s41576-021-00408-x · Cited by 1,009
Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19
O’Brien, M. P., Forleo-Neto, E., Musser, B. J., Isa, F., Chan, K.-C., Sarkar, N., Bar, K. J., Barnabas, R. V., Barouch, D. H., Cohen, M. S., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2109682 · Cited by 447
Self-citationAbani, O., Abbas, A., Abbas, F., Abbas, M., Abbasi, S., Abbass, H., Abbott, A., Abdallah, N., Abdelaziz, A., Abdelfattah, M., et al. (2022) · The Lancet · doi:10.1016/s0140-6736(22)00163-5 · Cited by 369
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Metadata
- Authors
- Weinreich, D. M., Sivapalasingam, S., Norton, T., Ali, S., Gao, H., Bhore, R., Xiao, J., Hooper, A. T., Hamilton, J. D., Musser, B. J., Rofail, D., Hussein, M., Im, J., Atmodjo, D. Y., Perry, C., Pan, C., Mahmood, A., Hosain, R., Davis, J. D., Turner, K. C., Baum, A., Kyratsous, C. A., Kim, Y., Cook, A., Kampman, W., Roque-Guerrero, L., Acloque, G., Aazami, H., Cannon, K., Simón-Campos, J. A., Bocchini, J. A., Kowal, B., DiCioccio, A. T., Soo, Y., Geba, G. P., Stahl, N., Lipsich, L., Braunstein, N., Herman, G., & Yancopoulos, G. D.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-12-02
- Volume
- 385
- Issue
- 23
- Pages
- e81-e81
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3204153794
- Cited by
- 632
- References
- 19
- FWCI
- 41.61
- Type
- journal article
- Language
- en
- Open access
- green
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