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

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Sekine, Leo ; Arns, Beatriz ; Fabro, Bruna R. ; Cipolatt, Murillo M. ; Machado, Rafael R. G. ; Durigon, Edison L. ; Parolo, Edino ; Pellegrini, Jose Augusto S. ; Viana, Marina V. ; Schwarz, Patricia ; Lisboa, Thiago C. ; Dora, Jose Miguel S. ; Portich, Julia P. ; Paz, Alessandra A. ; Silla, Lucia ; Balsan, Almeri M. ; Schirmer, Felipe Da-Silva ; Franz, Juliana P. M. ; Da-Silveira, Luciana M. ; Breunig, Raquel C. ; Petersen, Viviana ; Sosnoski, Monalisa ; Mesquita, Nanci F. ; Volpato, Fabiana Caroline Z. ; Sganzerla, Daniel ; Falavigna, Maicon ; Rosa, Regis G. ; Zavascki, Alexandre P. ; PLACOVID Study Grp

• Document type: Journal article
• Source: European Respiratory Journal; v. 59, n. 2, p. 11-pg., 2022-02-01.

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. The primary outcome was the proportion of patients with clinical improvement 28 days after enrolment. Results A total of 160 (80 in each arm) patients (66.3% critically ill, 33.7% severely ill) completed the trial. The median (interquartile range (IQR)) age was 60.5 (48-68) years; 58.1% were male and the median (IQR) time from symptom onset to randomisation was 10 (8-12) days. Neutralising antibody titres >1:80 were present in 133 (83.1%) patients at baseline. The proportion of patients with clinical improvement on day 28 was 61.3% in the CP+SOC group and 65.0% in the SOC group (difference -3.7%, 95% CI -18.8-11.3%). The results were similar in the severe and critically ill subgroups. There was no significant difference between CP+SOC and SOC groups in pre-specified secondary outcomes, including 28-day mortality, days alive and free of respiratory support and duration of invasive ventilatory support. Inflammatory and other laboratory marker values on days 3, 7 and 14 were similar between groups. Conclusions CP+SOC did not result in a higher proportion of clinical improvement on day 28 in hospitalised patients with COVID-19 compared to SOC alone. (AU)

• FAPESP's process: 20/06409-1 - Evaluation of humoral immune response and inflammatory response in patients with confirmed diagnosis of COVID-19 at Hospital Sírio Libanês and correlation with disease severity
• Grantee: Edison Luiz Durigon
• Support Opportunities: Regular Research Grants
• FAPESP's process: 16/20045-7 - Antigen discovery and development of serological diagnostic methods and vaccine approaches against the Zika Virus (ZIKV)
• Grantee: Luis Carlos de Souza Ferreira
• Support Opportunities: Research Projects - Thematic Grants