Safety and efficacy of convalescent plasma for COVID-19 in the pre-vaccine era, and implementation in a large healthcare system: A phase I/II randomized, multicentre clinical trial (PC-COVID)

INTRODUCTION: A phase 2 trial was conducted to evaluate the safety and efficacy of convalescent plasma (CP) for patients admitted with COVID-19 in the pre-vaccine era. METHODS: CP was compared to standard of care (SoC) in a randomized clinical trial in patients admitted with COVID-19 pneumonia and with either hypoxia and/or some underlying condition from April to December 2020 in 15 hospitals in Andalusia, Spain. The primary endpoints were adverse events and failure (all-cause death and need for mechanical ventilation during the first 21 days). RESULT: The procedure for CP was developed and worked properly. Overall, 72 patients of 88 evaluated were recruited (37 and 35) assigned to CP and SoC. Median duration of COVID-19 related symptoms was 7 and 6 days, and median oxygen saturation at randomization was 93% and 92.5% in experimental and control arms, respectively. Overall, 8 (21.6%) patients in the experimental CP group (non related to CP) and 8 (22.9%) in the control group developed grade 3 adverse events (relative risk [RR] 0.94; 95% CI: 0.39-2.24); failure occurred in 3 (8.1%) and 4 (11.4%) patients, respectively ([RR] 0.94, CI: 0.14-6.35 for both events). No differences in secondary endpoints (change in inflammatory parameters, negativization of SARS-CoV-2 PCR or duration of hospital stay) were found. CONCLUSIONS: The results suggested that CP is safe for use in COVID-19 patients, although no significant efficacy signal could be observed. A successful regional system for CP administration was developed.