| Autor: |
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 |
| Předmět: |
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| Zdroj: |
Journal of Infectious Diseases; Jan2023, Vol. 227 Issue 1, p23-34, 12p |
| Abstrakt: |
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 log10 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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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