tetano
Editor, Senior Moderator
J Infect Dis
. 2022 Jul 27;jiac320.
doi: 10.1093/infdis/jiac320. Online ahead of print.
Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19
Selin Somersan-Karakaya[SUP] 1 [/SUP], Eleftherios Mylonakis[SUP] 2 [/SUP], Vidya P Menon[SUP] 3 [/SUP], Jason C Wells[SUP] 4 1 [/SUP], Shazia Ali[SUP] 1 [/SUP], Sumathi Sivapalasingam[SUP] 1 [/SUP], Yiping Sun[SUP] 1 [/SUP], Rafia Bhore[SUP] 1 [/SUP], Jingning Mei[SUP] 1 [/SUP], Jutta Miller[SUP] 1 [/SUP], Lisa Cupelli[SUP] 1 [/SUP], Eduardo Forleo-Neto[SUP] 1 [/SUP], Andrea T Hooper[SUP] 1 [/SUP], Jennifer D Hamilton[SUP] 1 [/SUP], Cynthia Pan[SUP] 1 [/SUP], Viet Pham[SUP] 1 [/SUP], Yuming Zhao[SUP] 1 [/SUP], Romana Hosain[SUP] 1 [/SUP], Adnan Mahmood[SUP] 1 [/SUP], John D Davis[SUP] 1 [/SUP], Kenneth C Turner[SUP] 1 [/SUP], Yunji Kim[SUP] 1 [/SUP], Amanda Cook[SUP] 1 [/SUP], Bari Kowal[SUP] 1 [/SUP], Yuhwen Soo[SUP] 1 [/SUP], A Thomas DiCioccio[SUP] 1 [/SUP], Gregory P Geba[SUP] 1 [/SUP], Neil Stahl[SUP] 1 [/SUP], Leah Lipsich[SUP] 1 [/SUP], Ned Braunstein[SUP] 1 [/SUP], Gary A Herman[SUP] 1 [/SUP], George D Yancopoulos[SUP] 1 [/SUP], David M Weinreich[SUP] 1 [/SUP], COVID-19 Phase 2/3 Hospitalized Trial Team
Affiliations
Abstract
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 I/II/III, 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: 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% CI, -0.51 to -0.05; P = .0172). The primary clinical analysis of death or mechanical ventilation (death/MV) from day 6-29 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.
Keywords: COVID-19; SARS-CoV-2; coronavirus; hospitalized; monoclonal antibody.
. 2022 Jul 27;jiac320.
doi: 10.1093/infdis/jiac320. Online ahead of print.
Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19
Selin Somersan-Karakaya[SUP] 1 [/SUP], Eleftherios Mylonakis[SUP] 2 [/SUP], Vidya P Menon[SUP] 3 [/SUP], Jason C Wells[SUP] 4 1 [/SUP], Shazia Ali[SUP] 1 [/SUP], Sumathi Sivapalasingam[SUP] 1 [/SUP], Yiping Sun[SUP] 1 [/SUP], Rafia Bhore[SUP] 1 [/SUP], Jingning Mei[SUP] 1 [/SUP], Jutta Miller[SUP] 1 [/SUP], Lisa Cupelli[SUP] 1 [/SUP], Eduardo Forleo-Neto[SUP] 1 [/SUP], Andrea T Hooper[SUP] 1 [/SUP], Jennifer D Hamilton[SUP] 1 [/SUP], Cynthia Pan[SUP] 1 [/SUP], Viet Pham[SUP] 1 [/SUP], Yuming Zhao[SUP] 1 [/SUP], Romana Hosain[SUP] 1 [/SUP], Adnan Mahmood[SUP] 1 [/SUP], John D Davis[SUP] 1 [/SUP], Kenneth C Turner[SUP] 1 [/SUP], Yunji Kim[SUP] 1 [/SUP], Amanda Cook[SUP] 1 [/SUP], Bari Kowal[SUP] 1 [/SUP], Yuhwen Soo[SUP] 1 [/SUP], A Thomas DiCioccio[SUP] 1 [/SUP], Gregory P Geba[SUP] 1 [/SUP], Neil Stahl[SUP] 1 [/SUP], Leah Lipsich[SUP] 1 [/SUP], Ned Braunstein[SUP] 1 [/SUP], Gary A Herman[SUP] 1 [/SUP], George D Yancopoulos[SUP] 1 [/SUP], David M Weinreich[SUP] 1 [/SUP], COVID-19 Phase 2/3 Hospitalized Trial Team
Affiliations
- PMID: 35895508
- DOI: 10.1093/infdis/jiac320
Abstract
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 I/II/III, 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: 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% CI, -0.51 to -0.05; P = .0172). The primary clinical analysis of death or mechanical ventilation (death/MV) from day 6-29 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.
Keywords: COVID-19; SARS-CoV-2; coronavirus; hospitalized; monoclonal antibody.