Sekine: Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial

Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial

Sekine et al., European Respiratory Journal, doi:10.1183/13993003.01471-2021, PLACOVID, NCT04547660 (history)

Sekine et al., Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial, European Respiratory Journal, doi:10.1183/13993003.01471-2021, PLACOVID, NCT04547660

Jul 2021 Source PDF

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RCT 160 hospitalized patients in Brazil, showing no significant difference in outcomes with convalescent plasma.

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risk of death, 38.5% higher, RR 1.38, p = 0.42, treatment 18 of 80 (22.5%), control 13 of 80 (16.2%), day 28.

risk of death, 100% higher, RR 2.00, p = 0.28, treatment 10 of 80 (12.5%), control 5 of 80 (6.2%), day 14.

risk of no improvement, 10.7% higher, RR 1.11, p = 0.74, treatment 31 of 80 (38.8%), control 28 of 80 (35.0%), day 28.

hospitalization time, 66.7% higher, relative time 1.67, p = 0.87, treatment 80, control 80.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Sekine et al., 8 Jul 2021, Randomized Controlled Trial, Brazil, peer-reviewed, 28 authors, study period 15 July, 2020 - 10 December, 2020, average treatment delay 10.0 days, trial NCT04547660 (history) (PLACOVID).

Contact: azavascki@hcpa.edu.br, permissions@ersnet.org.

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Abstract: EUROPEAN RESPIRATORY JOURNAL ORIGINAL RESEARCH ARTICLE L. SEKINE ET AL. Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial Leo Sekine 1,2, Beatriz Arns3, Bruna R. Fabro3, Murillo M. Cipolatt3, Rafael R.G. Machado 4, Edison L. Durigon4,5, Edino Parolo6, José Augusto S. Pellegrini6, Marina V. Viana6, Patrícia Schwarz6, Thiago C. Lisboa6, José Miguel S. Dora 7,8, Julia P. Portich9, Alessandra A. Paz9, Lucia Silla9, Almeri M. Balsan1, Felipe da-Silva Schirmer1, Juliana P.M. Franz1, Luciana M. da-Silveira1, Raquel C. Breunig1, Viviana Petersen1, Monalisa Sosnoski1, Nanci F. Mesquita1, Fabiana Caroline Z. Volpato10,11, Daniel Sganzerla12, Maicon Falavigna12, Regis G. Rosa13 and Alexandre P. Zavascki 3,8 on behalf of PLACOVID Study Group14 1 Transfusion Medicine Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. 2Medical Sciences Post-Graduate Program, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. 3Infectious Diseases Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. 4Dept of Microbiology, Institute of Biomedical Sciences, University of São Paulo, São Paulo, Brazil. 5Scientific Platform Pasteur USP, São Paulo, Brazil. 6Critical Care Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. 7Internal Medicine Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. 8Dept of Internal Medicine, Universidade federal do Rio Grande do Sul, Porto Alegre, Brazil. 9Clinical Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. 10Laboratório de Diagnóstico de SARS-CoV-2, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. 11 Laboratório de Pesquisa em Resistência Bacteriana (LABRESIS), Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. 12Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil. 13Intensive Care Service, Hospital Moinhos de Vento, Porto Alegre, Brazil. 14The members of the PLACOVID Study Group are listed in the acknowledgements section. Corresponding author: Alexandre P. Zavascki (azavascki@hcpa.edu.br) Shareable abstract (@ERSpublications) In this open-label, randomised clinical trial, two infusions of convalescent plasma therapy plus standard of care compared to standard of care did not result in higher proportion of clinical improvement on day 28 in patients with severe COVID-19 https://bit.ly/2TXuB6S Cite this article as: Sekine L, Arns B, Fabro BR, et al. Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial. Eur Respir J 2022; 59: 2101471 [DOI: 10.1183/ 13993003.01471-2021]. Copyright ©The authors 2022. This version is distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. For commercial reproduction rights and permissions contact permissions@ersnet.org This article has an editorial commentary: https://doi.org/10.1183/ 13993003.02076-2021 Received: 30 April 2021 Accepted: 16 June 2021 Abstract Background The effects of convalescent plasma (CP) therapy in hospitalised patients with coronavirus disease 2019 (COVID-19) remain uncertain. This study investigates the effect of CP on clinical improvement in these patients. Methods This is an investigator-initiated, randomised, parallel arm, open-label, superiority clinical trial. Patients were randomly (1:1) assigned to two infusions of CP plus standard of care (SOC) or SOC alone...

Late treatment
is less effective

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