Administration of convalescent plasma to patients with COVID-19: A clinical trial from Paraguay

Abstract

Introduction: During the "Spanish flu" pandemic of 1918, the use of plasma obtained from convalescent individuals was introduced as a potential treatment for patients affected by the disease. This paradigm can be extrapolated to the context of the pandemic caused by SARS-CoV-2 virus and the disease known as COVID-19. Individuals who overcome this disease could represent the key to therapy based on the administration of hyperimmune plasma to infected patients, particularly to those with prognostic factors of aggravation. Objective: This study aimed to prove the benefit of convalescent plasma treatment in patients with COVID-19 in terms of their evolution and outcome, taking into account the clinical characteristics of the disease. Methodology: This was a randomized controlled clinical trial. Patients were randomized 1:1 to be part of the experimental or control groups. The experimental group consisted of patients with COVID-19 who were hospitalized at the Hospital de Clínicas of the Universidad Nacional de Asunción, regardless of the severity of their clinical condition, and who received 200 ml of convalescent plasma during days 1 and 2 of their hospitalization. The control group consisted of patients with COVID-19 who were hospitalized at the Hospital de Clínicas with conventional treatment, according to the current protocol of the Ministry of Public Health and Social Welfare of Paraguay. Pearson's chi-square test was used to establish associations between the variables studied, and odds ratios was calculated with confidence intervals. Statistical significance was set at p<0.05. Results: A total of 124 patients were included in the study and randomized at a 1:1 ratio, resulting in 62 and 62 patients in the experimental and control groups, respectively. The median age of the patients in the experimental group was 59 years and 51.6% were men. The majority of the patients in both groups were diagnosed with critical COVID-19 (51.6% in the experimental group and 45.1 % in the control group). The overall mortality rates in the control group was 25.8 % and that in the experimental group was 32.3%, respectively. No statistically significant association was found between convalescent plasma administration and clinical outcomes [p=0.277, 95% OR=1.3 (0.6-2.9)]. Conclusions: No significant differences were found in clinical outcome between patients treated with convalescent plasma with high levels of IgG anti-SARS-CoV-2 antibodies and those who received conventional treatment.