Convalescent Plasma in COVID-19; Mortality-Safety First Results of the Prospective Multicenter FALP 001-2020 Trial

Abstract

Background: The use of Convalescent Plasma (CP) to treat COVID-19 has shown promising results; however, its \n effectiveness remains uncertain. The purpose of this study was to determine the safety and mortality of CP among \n patients hospitalized with COVID-19. \nStudy design and methods: This multicenter, open-label, uncontrolled clinical trial is currently being conducted \n at nine hospitals in Chile. Patients hospitalized due to COVID-19 with less than 14 days since symptom onset were \n eligible. Enrolled patients were classified into four groups: Patients with cancer and severe COVID-19. Patients with \n cancer and non-severe COVID-19. Patients with severe COVID-19 and patients with non-severe COVID-19 only. \n The intervention involved two 200-cc. CP transfusions with anti-SARS-CoV-2 IgG titers ≥ 1:320 collected from \n COVID-19-recovered donors \nResults: 192 patients hospitalized for COVID-19 received CP transfusions. At the first transfusion, 90.6% fulfilled \n the criteria for severity, and 41.1% required mechanical ventilation. 11.5% of the patients had cancer. Overall, 7-day \n and 30-day mortality since the first CP transfusion was 5.7% and 16.1% respectively. There were no differences at \n either time point in mortality between the four groups. Patients on mechanical ventilation when receiving CP had \n higher mortality rates than those who were not: 22.8% (95% C.I. 14.1-33.6%) vs. 11.5% (95% C.I. 6.3–18.9%) \n (p=0.037). Overall, 30-day mortality was higher in patients over 65 than in younger patients: 26.7% (95% C.I. 16.1– \n 39.7%) (p=0.019). Severe adverse events were reported in four patients (2.1%) with an overall transfusion-related \n lung injury rate of 1.56%. No CP-related deaths occurred. \nDiscussion: CP is safe when used in patients with COVID-19 even when also presenting severity criteria or risk \n factors. Our mortality rate is comparable to reports from larger studies. Controlled clinical trials are required to \n determine efficacy. \nConclusion: CP is safe when used in the COVID-19 population even for those who present severity criteria and/or \n risk factors for poor prognosis including cancer. In-depth analyses of the serological and molecular characteristics of \n CP are needed to evaluate the efficacy of this intervention through controlled clinical trials. \nRegistration: NCT04384588