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

Authors :
Vasiliki Pappa
Anthi Bouchla
Evangelos Terpos
Thomas P. Thomopoulos
Margherita Rosati
Dimitris Stellas
Anastasia Antoniadou
Andreas Mentis
Sotirios G. Papageorgiou
Marianna Politou
Anastasia Kotanidou
Ioannis Kalomenidis
Garyfalia Poulakou
Edison Jahaj
Eleni Korompoki
Sotiria Grigoropoulou
Xintao Hu
Jenifer Bear
Sevasti Karaliota
Robert Burns
Maria Pagoni
Ioannis Trontzas
Elisavet Grouzi
Stavroula Labropoulou
Kostantinos Stamoulis
Aristotelis Bamias
Sotirios Tsiodras
Barbara K. Felber
George N. Pavlakis
Meletios- Athanasios Dimopoulos
Source :
Microorganisms, Vol 9, Iss 4, p 806 (2021)
Publication Year :
2021
Publisher :
MDPI AG, 2021.

Abstract

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).

Details

Language :
English
ISSN :
20762607
Volume :
9
Issue :
4
Database :
Directory of Open Access Journals
Journal :
Microorganisms
Publication Type :
Academic Journal
Accession number :
edsdoj.1d5a585b481e4fd7b665db566cb0b223
Document Type :
article
Full Text :
https://doi.org/10.3390/microorganisms9040806