Convalescent Plasma for Preventing Critical Illness in COVID-19: a Phase 2 Trial and Immune Profile.

Autor: Sturek JM; Division of Pulmonary & Critical Care Medicine, Department of Medicine, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA., Thomas TA; Division of Infectious Diseases & International Health, Department of Medicine, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA., Gorham JD; Division of Laboratory Medicine, Department of Pathology, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA., Sheppard CA; Division of Laboratory Medicine, Department of Pathology, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA., Raymond AH; Division of Cardiology, Department of Medicine, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA., Petros De Guex K; Division of Infectious Diseases & International Health, Department of Medicine, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA., Harrington WB; Division of Infectious Diseases & International Health, Department of Medicine, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA., Barros AJ; Division of Pulmonary & Critical Care Medicine, Department of Medicine, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA., Madden GR; Division of Infectious Diseases & International Health, Department of Medicine, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA., Alkabab YM; Division of Infectious Diseases & International Health, Department of Medicine, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA., Lu DY; College of Arts and Sciences, Cornell University, Ithaca, New York, USA., Liu Q; The Wistar Institute, Philadelphia, Pennsylvania, USA., Poulter MD; Division of Laboratory Medicine, Department of Pathology, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA., Mathers AJ; Division of Infectious Diseases & International Health, Department of Medicine, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA.; Division of Laboratory Medicine, Department of Pathology, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA., Thakur A; Division of Hematology and Oncology, Department of Medicine, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA., Schalk DL; Division of Hematology and Oncology, Department of Medicine, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA., Kubicka EM; Division of Hematology and Oncology, Department of Medicine, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA., Lum LG; Division of Hematology and Oncology, Department of Medicine, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA., Heysell SK; Division of Infectious Diseases & International Health, Department of Medicine, University of Virginiagrid.412587.dgrid.27755.32 School of Medicine, Charlottesville, Virginia, USA.
Jazyk: angličtina
Zdroj: Microbiology spectrum [Microbiol Spectr] 2022 Feb 23; Vol. 10 (1), pp. e0256021. Date of Electronic Publication: 2022 Feb 23.
DOI: 10.1128/spectrum.02560-21
Abstrakt: The COVID-19 pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an unprecedented event requiring frequent adaptation to changing clinical circumstances. Convalescent immune plasma (CIP) is a promising treatment that can be mobilized rapidly in a pandemic setting. We tested whether administration of SARS-CoV-2 CIP at hospital admission could reduce the rate of ICU transfer or 28-day mortality or alter levels of specific antibody responses before and after CIP infusion. In a single-arm phase II study, patients >18 years-old with respiratory symptoms with confirmed COVID-19 infection who were admitted to a non-ICU bed were administered two units of CIP within 72 h of admission. Levels of SARS-CoV-2 detected by PCR in the respiratory tract and circulating anti-SARS-CoV-2 antibody titers were sequentially measured before and after CIP transfusion. Twenty-nine patients were transfused high titer CIP and 48 contemporaneous comparable controls were identified. All classes of antibodies to the three SARS-CoV-2 target proteins were significantly increased at days 7 and 14 post-transfusion compared with baseline ( P  < 0.01). Anti-nucleocapsid IgA levels were reduced at day 28, suggesting that the initial rise may have been due to the contribution of CIP. The groups were well-balanced, without statistically significant differences in demographics or co-morbidities or use of remdesivir or dexamethasone. In participants transfused with CIP, the rate of ICU transfer was 13.8% compared to 27.1% for controls with a hazard ratio 0.506 (95% CI 0.165-1.554), and 28-day mortality was 6.9% compared to 10.4% for controls, hazard ratio 0.640 (95% CI 0.124-3.298). IMPORTANCE Transfusion of high-titer CIP to non-critically ill patients early after admission with COVID-19 respiratory disease was associated with significantly increased anti-SARS-CoV-2 specific antibodies (compared to baseline) and a non-significant reduction in ICU transfer and death (compared to controls). This prospective phase II trial provides a suggestion that the antiviral effects of CIP from early in the COVID-19 pandemic may delay progression to critical illness and death in specific patient populations. This study informs the optimal timing and potential population of use for CIP in COVID-19, particularly in settings without access to other interventions, or in planning for future coronavirus pandemics.
Databáze: MEDLINE
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