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)
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 72 participants or records.
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