A Phase II Study on the Use of Convalescent Plasma for the Treatment of Severe COVID-19- A Propensity Score-Matched Control Analysis

Pappa, Vasiliki; Bouchla, Anthi; Terpos, Evangelos; Thomopoulos, Thomas P.; Rosati, Margherita; Stellas, Dimitris; Antoniadou, Anastasia; Mentis, Andreas; Papageorgiou, Sotirios G.; Politou, Marianna; Kotanidou, Anastasia; Kalomenidis, Ioannis; Poulakou, Garyfalia; Jahaj, Edison; Korompoki, Eleni; Grigoropoulou, Sotiria; Hu, Xintao; Bear, Jenifer; Karaliota, Sevasti; Burns, Robert; Pagoni, Maria; Trontzas, Ioannis; Grouzi, Elisavet; Labropoulou, Stavroula; Stamoulis, Kostantinos; Bamias, Aristotelis; Tsiodras, Sotirios; Felber, Barbara K.; Pavlakis, George N.; Dimopoulos, Meletios- Athanasios

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).