Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial
Leo Sekine, Beatriz Arns, Bruna R. Fabro, Murillo M. Cipolatt, Rafael Rahal Guaragna Machado, Edison Luíz Durigon, Édino Parolo, José Augusto Santos Pellegrini, Marina Verçoza Viana, Patrícia Schwarz, Thiago Lisboa, José Miguel Dora, Júlia Plentz Portich, Alessandra Aparecida Paz, Lúcia Mariano da Rocha Silla, Almeri Marlene Balsan, F Schirmer, Juliana Pires Marafon Franz, Luciana M. da-Silveira, Raquel Cristine Breunig, Viviana Petersen, Monalisa Sosnoski, Nanci F. Mesquita, Fabiana Caroline Zempulski Volpato, Daniel Sganzerla, Maicon Falavigna, Régis Goulart Rosa, Alexandre Prehn Zavascki
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.