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Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19
BACKGROUND: The open-label RECOVERY study reported improved survival in hospitalized, SARS-CoV-2 seronegative patients treated with casirivimab and imdevimab (CAS + IMD). METHODS: In this phase 1/2/3, double-blind, placebo-controlled trial conducted prior to widespread circulation of Delta and Omicr...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9384575/ https://www.ncbi.nlm.nih.gov/pubmed/35895508 http://dx.doi.org/10.1093/infdis/jiac320 |
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author | Somersan-Karakaya, Selin Mylonakis, Eleftherios Menon, Vidya P Wells, Jason C Ali, Shazia Sivapalasingam, Sumathi Sun, Yiping Bhore, Rafia Mei, Jingning Miller, Jutta Cupelli, Lisa Forleo-Neto, Eduardo Hooper, Andrea T Hamilton, Jennifer D Pan, Cynthia Pham, Viet Zhao, Yuming Hosain, Romana Mahmood, Adnan Davis, John D Turner, Kenneth C Kim, Yunji Cook, Amanda Kowal, Bari Soo, Yuhwen DiCioccio, A Thomas Geba, Gregory P Stahl, Neil Lipsich, Leah Braunstein, Ned Herman, Gary A Yancopoulos, George D Weinreich, David M |
author_facet | Somersan-Karakaya, Selin Mylonakis, Eleftherios Menon, Vidya P Wells, Jason C Ali, Shazia Sivapalasingam, Sumathi Sun, Yiping Bhore, Rafia Mei, Jingning Miller, Jutta Cupelli, Lisa Forleo-Neto, Eduardo Hooper, Andrea T Hamilton, Jennifer D Pan, Cynthia Pham, Viet Zhao, Yuming Hosain, Romana Mahmood, Adnan Davis, John D Turner, Kenneth C Kim, Yunji Cook, Amanda Kowal, Bari Soo, Yuhwen DiCioccio, A Thomas Geba, Gregory P Stahl, Neil Lipsich, Leah Braunstein, Ned Herman, Gary A Yancopoulos, George D Weinreich, David M |
author_sort | Somersan-Karakaya, Selin |
collection | PubMed |
description | BACKGROUND: The open-label RECOVERY study reported improved survival in hospitalized, SARS-CoV-2 seronegative patients treated with casirivimab and imdevimab (CAS + IMD). METHODS: In this phase 1/2/3, double-blind, placebo-controlled trial conducted prior to widespread circulation of Delta and Omicron, hospitalized COVID-19 patients were randomized (1:1:1) to 2.4 g or 8.0 g CAS + IMD or placebo, and characterized at baseline for viral load and SARS-CoV-2 serostatus. RESULTS: In total, 1336 patients on low-flow or no supplemental (low-flow/no) oxygen were treated. The primary endpoint was met in seronegative patients, the least-squares mean difference (CAS + IMD versus placebo) for time-weighted average change from baseline in viral load through day 7 was −0.28 log(10) copies/mL (95% confidence interval [CI], −.51 to −.05; P = .0172). The primary clinical analysis of death or mechanical ventilation from day 6 to 29 in patients with high viral load had a strong positive trend but did not reach significance. CAS + IMD numerically reduced all-cause mortality in seronegative patients through day 29 (relative risk reduction, 55.6%; 95% CI, 24.2%–74.0%). No safety concerns were noted. CONCLUSIONS: In hospitalized COVID-19 patients on low-flow/no oxygen, CAS + IMD reduced viral load and likely improves clinical outcomes in the overall population, with the benefit driven by seronegative patients, and no harm observed in seropositive patients. CLINICAL TRIALS REGISTRATION: NCT04426695. |
format | Online Article Text |
id | pubmed-9384575 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-93845752022-08-18 Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19 Somersan-Karakaya, Selin Mylonakis, Eleftherios Menon, Vidya P Wells, Jason C Ali, Shazia Sivapalasingam, Sumathi Sun, Yiping Bhore, Rafia Mei, Jingning Miller, Jutta Cupelli, Lisa Forleo-Neto, Eduardo Hooper, Andrea T Hamilton, Jennifer D Pan, Cynthia Pham, Viet Zhao, Yuming Hosain, Romana Mahmood, Adnan Davis, John D Turner, Kenneth C Kim, Yunji Cook, Amanda Kowal, Bari Soo, Yuhwen DiCioccio, A Thomas Geba, Gregory P Stahl, Neil Lipsich, Leah Braunstein, Ned Herman, Gary A Yancopoulos, George D Weinreich, David M J Infect Dis Major Article BACKGROUND: The open-label RECOVERY study reported improved survival in hospitalized, SARS-CoV-2 seronegative patients treated with casirivimab and imdevimab (CAS + IMD). METHODS: In this phase 1/2/3, double-blind, placebo-controlled trial conducted prior to widespread circulation of Delta and Omicron, hospitalized COVID-19 patients were randomized (1:1:1) to 2.4 g or 8.0 g CAS + IMD or placebo, and characterized at baseline for viral load and SARS-CoV-2 serostatus. RESULTS: In total, 1336 patients on low-flow or no supplemental (low-flow/no) oxygen were treated. The primary endpoint was met in seronegative patients, the least-squares mean difference (CAS + IMD versus placebo) for time-weighted average change from baseline in viral load through day 7 was −0.28 log(10) copies/mL (95% confidence interval [CI], −.51 to −.05; P = .0172). The primary clinical analysis of death or mechanical ventilation from day 6 to 29 in patients with high viral load had a strong positive trend but did not reach significance. CAS + IMD numerically reduced all-cause mortality in seronegative patients through day 29 (relative risk reduction, 55.6%; 95% CI, 24.2%–74.0%). No safety concerns were noted. CONCLUSIONS: In hospitalized COVID-19 patients on low-flow/no oxygen, CAS + IMD reduced viral load and likely improves clinical outcomes in the overall population, with the benefit driven by seronegative patients, and no harm observed in seropositive patients. CLINICAL TRIALS REGISTRATION: NCT04426695. Oxford University Press 2022-07-27 /pmc/articles/PMC9384575/ /pubmed/35895508 http://dx.doi.org/10.1093/infdis/jiac320 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Major Article Somersan-Karakaya, Selin Mylonakis, Eleftherios Menon, Vidya P Wells, Jason C Ali, Shazia Sivapalasingam, Sumathi Sun, Yiping Bhore, Rafia Mei, Jingning Miller, Jutta Cupelli, Lisa Forleo-Neto, Eduardo Hooper, Andrea T Hamilton, Jennifer D Pan, Cynthia Pham, Viet Zhao, Yuming Hosain, Romana Mahmood, Adnan Davis, John D Turner, Kenneth C Kim, Yunji Cook, Amanda Kowal, Bari Soo, Yuhwen DiCioccio, A Thomas Geba, Gregory P Stahl, Neil Lipsich, Leah Braunstein, Ned Herman, Gary A Yancopoulos, George D Weinreich, David M Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19 |
title | Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19 |
title_full | Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19 |
title_fullStr | Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19 |
title_full_unstemmed | Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19 |
title_short | Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19 |
title_sort | casirivimab and imdevimab for the treatment of hospitalized patients with covid-19 |
topic | Major Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9384575/ https://www.ncbi.nlm.nih.gov/pubmed/35895508 http://dx.doi.org/10.1093/infdis/jiac320 |
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