Effect of Convalescent Plasma in Critically Ill Patients With COVID-19: An Observational Study

Pedro Kurtz; Cassia Righy; Monica Gadelha; Fernando A Bozza; Patricia T Bozza; Bruno Gonçalves; Leonardo S L Bastos; Andre M Vale; Luiza M Higa; Leda Castilho; Fabio L Monteiro; Nestor Charris; Fernanda Fialho; Ricardo Turon; Alexandro Guterres; Renan Lyra Miranda; Carlos Henrique de Azeredo Lima; Vanessa de Caro; Marco Aurelio Prazeres; Nina Ventura; Clara Gaspari; Fabio Miranda; Paulo Jose da Mata; Margarida Pêcego; Sheila Mateos; Maria Esther Lopes; Shirley Castilho; Álvaro Oliveira; Carla Boquimpani; Andréa Rabello; Josiane Lopes; Orlando Conceição Neto; Orlando da C Ferreira Jr; Amilcar Tanuri; Paulo Niemeyer Filho; Luiz Amorim

doi:10.3389/fmed.2021.630982

Effect of Convalescent Plasma in Critically Ill Patients With COVID-19: An Observational Study

Front Med (Lausanne). 2021 Jan 28:8:630982. doi: 10.3389/fmed.2021.630982. eCollection 2021.

Authors

Pedro Kurtz¹, Cassia Righy¹, Monica Gadelha¹, Fernando A Bozza^{2

3}, Patricia T Bozza⁴, Bruno Gonçalves¹, Leonardo S L Bastos⁵, Andre M Vale⁶, Luiza M Higa⁷, Leda Castilho⁸, Fabio L Monteiro⁷, Nestor Charris¹, Fernanda Fialho¹, Ricardo Turon¹, Alexandro Guterres¹, Renan Lyra Miranda¹, Carlos Henrique de Azeredo Lima¹, Vanessa de Caro¹, Marco Aurelio Prazeres¹, Nina Ventura¹, Clara Gaspari¹, Fabio Miranda¹, Paulo Jose da Mata¹, Margarida Pêcego⁹, Sheila Mateos⁹, Maria Esther Lopes⁹, Shirley Castilho⁹, Álvaro Oliveira⁹, Carla Boquimpani⁹, Andréa Rabello⁹, Josiane Lopes⁹, Orlando Conceição Neto⁹, Orlando da C Ferreira Jr⁷, Amilcar Tanuri⁷, Paulo Niemeyer Filho¹, Luiz Amorim⁹

Affiliations

¹ Instituto Estadual do Cérebro Paulo Niemeyer, Rio de Janeiro, Brazil.
² D'Or Institute for Research and Education, Rio de Janeiro, Brazil.
³ National Institute of Infectious Disease Evandro Chagas, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
⁴ Laboratory of Immunopharmacology, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
⁵ Industrial Engineering Department, Pontifical Catholic University of Rio de Janeiro (PUC-Rio), Rio de Janeiro, Brazil.
⁶ Laboratory of Lymphocyte Biology, Program in Immunobiology, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
⁷ Laboratory of Molecular Virology, Department of Genetics, Institute of Biology, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
⁸ Laboratory of Cell Culture Engineering, COPPE, Chemical Engineering Program, Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
⁹ Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti (HEMORIO), Rio de Janeiro, Brazil.

Abstract

Background: Convalescent plasma is a potential therapeutic option for critically ill patients with coronavirus disease 19 (COVID-19), yet its efficacy remains to be determined. The aim was to investigate the effects of convalescent plasma (CP) in critically ill patients with COVID-19. Methods: This was a single-center prospective observational study conducted in Rio de Janeiro, Brazil, from March 17th to May 30th, with final follow-up on June 30th. We included 113 laboratory-confirmed COVID-19 patients with respiratory failure. Primary outcomes were time to clinical improvement and survival within 28 days. Secondary outcomes included behavior of biomarkers and viral loads. Kaplan-Meier analyses and Cox proportional-hazards regression using propensity score with inverse-probability weighing were performed. Results: 41 patients received CP and 72 received standard of care (SOC). Median age was 61 years (IQR 48-68), disease duration was 10 days (IQR 6-13), and 86% were mechanically ventilated. At least 29 out of 41CP-recipients had baseline IgG titers ≥ 1:1,080. Clinical improvement within 28 days occurred in 19 (46%) CP-treated patients, as compared to 23 (32%) in the SOC group [adjusted hazard ratio (aHR) 0.91 (0.49-1.69)]. There was no significant change in 28-day mortality (CP 49% vs. SOC 56%; aHR 0.90 [0.52-1.57]). Biomarker assessment revealed reduced inflammatory activity and increased lymphocyte count after CP. Conclusions: In this study, CP was not associated with clinical improvement or increase in 28-day survival. However, our study may have been underpowered and included patients with high IgG titers and life-threatening disease. Clinical Trial Registration: The study protocol was retrospectively registered at the Brazilian Registry of Clinical Trials (ReBEC) with the identification RBR-4vm3yy (http://www.ensaiosclinicos.gov.br).

Keywords: COVID-19; acute respiratory distress syndrome; convalescent plasma; coronavirus; survival.

Copyright © 2021 Kurtz, Righy, Gadelha, Bozza, Bozza, Gonçalves, Bastos, Vale, Higa, Castilho, Monteiro, Charris, Fialho, Turon, Guterres, Lyra Miranda, de Azeredo Lima, de Caro, Prazeres, Ventura, Gaspari, Miranda, Jose da Mata, Pêcego, Mateos, Lopes, Castilho, Oliveira, Boquimpani, Rabello, Lopes, Neto, Ferreira, Tanuri, Filho and Amorim.