Casirivimab and Imdevimab for the Treatment of Hospitalized Patients with COVID-19

the COVID-19 Phase 2/3 Hospitalized Trial Team

Research output: Contribution to journalArticlepeer-review

24 Scopus citations

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 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.

Original languageEnglish (US)
Pages (from-to)23-34
Number of pages12
JournalJournal of Infectious Diseases
Volume227
Issue number1
DOIs
StatePublished - Jan 1 2023

Keywords

  • COVID-19
  • SARS-CoV-2
  • coronavirus
  • hospitalized
  • monoclonal antibody
  • COVID-19 Drug Treatment
  • Double-Blind Method
  • Humans

ASJC Scopus subject areas

  • Medicine(all)

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