COVID-19 is a global pandemic associated with increased morbidity and mortality. Convalescent plasma (CP) infusion is a strategy of potential therapeutic benefit. We conducted a multicenter phase II study to evaluate the efficacy and safety of CP in patients with COVID-19, grade 4 or higher. To evaluate the efficacy of CP, a matched propensity score analysis was used comparing the intervention ( n = 59) to a control group ( n = 59). Sixty patients received CP within a median time of 7 days from symptom onset. During a median follow-up of 28.5 days, 56/60 patients fully recovered and 1 patient remained in the ICU. The death rate in the CP group was 3.4% vs. 13.6% in the control group. By multivariate analysis, CP recipients demonstrated a significantly reduced risk of death [HR: 0.04 (95% CI: 0.004–0.36), p : 0.005], significantly better overall survival by Kaplan–Meir analysis ( p < 0.001), and increased probability of extubation [OR: 30.3 (95% CI: 2.64–348.9), p : 0.006]. Higher levels of antibodies in the CP were independently associated with significantly reduced risk of death. CP infusion was safe with only one grade 3 adverse event (AE), which easily resolved. CP used early may be a safe and effective treatment for patients with severe COVID-19 (trial number NCT04408209).
【저자키워드】 COVID-19, convalescent plasma, Efficacy, SARS-CoV-2 antibodies, 【초록키워드】 Treatment, Trial, severe COVID-19, Intervention, ICU, global pandemic, Probability, survival, adverse event, Patient, death, plasma, Efficacy and safety, morbidity and mortality, Follow-up, multicenter, Analysis, Safe, death rate, symptom onset, Therapeutic benefit, control group, reduced risk, median time, CP group, recipient, CP infusion, propensity score analysis, effective, was used, evaluate, significantly, remained, conducted, median, demonstrated, resolved, levels of antibody, patients with COVID-19, 【제목키워드】 Control, phase,