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 effectiveness remains uncertain. The purpose of this study was to determine the safety and mortality of CP among patients hospitalized with COVID-19. Study Design and Methods: This multicenter, open-label, uncontrolled clinical trial is currently being conducted at nine hospitals in Chile. Patients hospitalized due to COVID-19 who were still within 14 days since symptom onset were classified into four groups: Patients with cancer and severe COVID-19. Patients with cancer and non-severe COVID-19. Patients with severe COVID-19 and patients with non-severe COVID-19 only. The intervention involved two 200-cc. CP transfusions with anti-SARS-CoV-2 IgG titers ≥ 1:320 collected from COVID-19-recovered donors. Results: 192 patients hospitalized for COVID-19 received CP transfusions. At the first transfusion, 90.6% fulfilled the criteria for severity, and 41.1% required mechanical ventilation. 11.5% of the patients had cancer. Overall 7-day and 30-day mortality since the first CP transfusion was 5.7% and 16.1% respectively. There were no differences at either time point in mortality between the four groups. Patients on mechanical ventilation when receiving CP had higher mortality rates than those who were not (22.8% vs. 11.5%; p = 0.037). Overall 30-day mortality was higher in patients over 65 than in younger patients (p = 0.019). Severe adverse events were reported in four patients (2.1%) with an overall transfusion-related lung injury rate of 1.56%. No CP-related deaths occurred. Discussion: CP is safe when used in patients with COVID-19 even when also presenting severity criteria or risk factors. Our mortality rate is comparable to reports from larger studies. Controlled clinical trials are required to determine efficacy.

Mortality Rates Among Hospitalized Patients With COVID-19 Treated With Convalescent Plasma: A Systematic Review and Meta-Analysis

“…In this context, we examined within-study mortality rates among patients treated with convalescent plasma earlier compared with those treated later in the COVID-19 disease course. This subgroup analysis examined 26 studies, including 2 RCTs 14 , 41 enrolling 5990 participants, 7 matched cohort studies 69 , 72 , 97 , 101 , 109 , 110 , 111 enrolling 1928 participants, and 17 case series 136 , 137 , 138 , 140 , 145 , 146 , 147 , 148 , 149 , 150 , 151 , 152 , 153 , 154 , 155 , 156 , 157 enrolling 10,530 participants. In this subgroup meta-analysis, treatment with convalescent plasma earlier in the COVID-19 disease course was associated with a 37% decrease in mortality rates compared with treatment later in the disease course, with a pooled risk ratio estimate of 0.63 (95% CI, 0.48-0.82).…”

Comparison of Mortality Between the Combination of Standard Therapy and Convalescent Plasma Therapy and Standard Therapy Only in Covid-19 Patients : Systematic Review and Meta-Analysis

“…Other studies stated that convalescent plasma therapy was safe for COVID-19 patients even though the patient had poor prognostic criteria for severity and/or risk factors. 17 In the overall meta-analysis study of 10 journals through forest plot, there was a significant difference between mortality in the convalescent plasma therapy group and standard therapy with the standard therapy only group. The mortality in a combination of convalescent plasma therapy group and standard therapy was lower than the mortality in standard therapy only.…”

Mortality rates among hospitalized patients with COVID-19 treated with convalescent plasma A Systematic review and meta-analysis

“…In this context, we examined within study mortality rates among patients treated with convalescent plasma earlier compared to those treated later in the COVID-19 disease course. This subgroup analysis examined 26 studies, including: 2 randomized clinical trials 14,41 enrolling 5,990 participants, 7 matched cohort studies 69,72,97,101,[109][110][111] enrolling 1,928 participants, and 17 case series [136][137][138]140,[145][146][147][148][149][150][151][152][153][154][155][156][157] enrolling 10,530 participants. In this subgroup meta-analysis, treatment with convalescent plasma earlier in the COVID-19 disease course was associated with a 37% decrease in mortality rates compared to treatment later in the disease course, with a pooled risk ratio estimate of 0.63 (95% CI, 0.48 to 0.82).…”