Randomized trial of the safety and efficacy of anti-SARS-CoV-2 mAb in the treatment of patients with nosocomial COVID-19 (CATCO-NOS).

Autor:	Tremblay A; Department of Medicine, University of Calgary Cumming School of Medicine and Alberta Health Services, Calgary, Alberta, Canada., Somayaji R; Department of Medicine, University of Calgary Cumming School of Medicine and Alberta Health Services, Calgary, Alberta, Canada., Hoang H; Department of Medicine, University of Alberta Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada.; Antimicrobial Stewardship, Covenant Health, Alberta, Canada., O'Neil C; Department of Medicine, University of Alberta Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada., Sonpar A; Department of Medicine, University of Alberta Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada., Conly J; Department of Medicine, University of Calgary Cumming School of Medicine and Alberta Health Services, Calgary, Alberta, Canada.; Snyder Institute for Chronic Diseases, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada., Murthy S; Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada., Fowler R; Departments of Medicine and Critical Care, Sunnybrook Hospital, Toronto, Ontario, Canada., Sligl W; Department of Medicine, University of Alberta Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada.
Jazyk:	angličtina
Zdroj:	Journal of the Association of Medical Microbiology and Infectious Disease Canada = Journal officiel de l'Association pour la microbiologie medicale et l'infectiologie Canada [J Assoc Med Microbiol Infect Dis Can] 2023 Nov 29; Vol. 8 (3), pp. 214-223. Date of Electronic Publication: 2023 Nov 29 (Print Publication: 2023).
DOI:	10.3138/jammi-2023-0008
Abstrakt:	Background: Patients with nosocomial acquisition of COVID-19 have poor outcomes but have not been included in therapeutic trials to date. Methods: A pragmatic open-label randomized controlled trial of anti-SARS-CoV-2 monoclonal antibodies (mAb) was performed in hospitalized patients with nosocomial COVID-19 infection in acute care hospitals spanning a provincial health care network. Participants within 5 days of first positive test or symptom onset were randomized to standard of care (SOC) plus a single dose intravenous mAb treatment (bamlanivimab or casirivimab/imdevimab) or SOC alone on a 2:1 basis. The primary study endpoint was the need for invasive mechanical ventilation (IMV) or inpatient mortality by day 60 after randomization. Results: Forty-six participants were enrolled from 13 hospitals between February 14 and October 8, 2021: 31 in the mAb and 15 in the SOC arm. IMV or inpatient mortality up to day 60 occurred in 4 (12.9%) participants in the mAb versus 3 in the SOC arm (20.0%), difference of -7.1% (95% CI -22.5 to 13.4, p = 0.67). The study was terminated early due to lack of equipoise as effectiveness of anti-viral therapies and mAb was published in similar high-risk patient populations. Conclusions: The trial was underpowered to detect meaningful differences given its early termination. The study does highlight the feasibility of undertaking trials in this patient population using a pragmatic approach allowing for trial participation and treatment access across a large health care network and may serve as a template for future designs. (© Association of Medical Microbiology and Infectious Disease Canada (AMMI Canada), 2023.)
Databáze:	MEDLINE
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