Factors Associated with Good Patient Outcomes Following Convalescent Plasma in COVID-19: A Prospective Phase II Clinical Trial

Abstract

We conducted a prospective single-arm open-label phase II clinical trial assessing the safety and efficacy of convalescent plasma in hospitalized COVID-19 patients. Convalescent plasma with sufficient IgG titer (1:320) obtained from recovered donors was administered to adult patients with either severe or critical COVID-19 illness. Primary outcomes were adverse events in association with plasma administration, and hospital mortality. Secondary outcomes included disease progression, recovery, length of stay, and hospital discharge. Of the 38 patients included in the analysis, 24 (63%) recovered and were discharged, and 14 (37%) died. Patients who received convalescent plasma early in the disease course (severe illness group) as compared to the patients that received convalescent plasma later in disease progression (critical illness group) had significantly lower hospital mortality 13% vs 55% (p<0.02) and shorter mean hospital length of stay 15.4 vs 33 days (p<0.01). One patient experienced a transient transfusion reaction. No other adverse effects of convalescent plasma infusion were observed. Our results suggest that convalescent plasma is safe and has the potential for positive impact on clinical outcomes including recovery and survival if given to patients early in the course of COVID-19 disease.

Convalescent plasma for COVID-19: male gender, older age and hospitalisation associated with high neutralising antibody levels, England, 22 April to 12 May 2020

“…At the time of a second wave of the coronavirus disease (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [1], effective antiviral therapies and vaccines are not yet available for clinical use [2,3]. Convalescent plasma collected from recovered COVID-19 patients has been suggested a safe and probably effective treatment in some nonrandomised studies [4][5][6][7][8][9][10][11]. As the efficacy of such therapy is most probably associated with the presence of high levels of neutralising antibody in the donated plasma, we investigated the clinical and demographic factors that are predictive of high titres in convalescent plasma donors.…”

Convalescent Plasma for the Treatment of Severe COVID-19

“…The importance of the early administration of CP emerged from an analysis of the results of a study by Ibrahim and colleagues in the USA: COVID-19 patients who received CP early in their disease course had a significantly lower in-hospital mortality rate (13% vs 55%, P=0.02) and a shorter mean time spent in hospital (15.4 days versus 33 days, P<0.01) than those receiving CP later in the disease progression. 35 These results were replicated in an Iranian case–control study by Abolghasemi and colleagues. 36 …”

“… NR - - Single center study - Large control population of pts - Retrospective study Rogers et al 34 Matched cohort study 64 severe COVID-19 pts/177 severe COVID-19 pts - No significant difference in risk of mortality or rate of hospital discharge was observed. 2 TRALI - Single center study - Non RCT Ibrahim et al 35 Prospective study/USA 38 severe or LT COVID-19 pts/- - Patients receiving CP early had significant lower mortality and shorter hospital length of stay than patients with more advanced COVID-19. 1 SAE - Homogenous population of pts - Non RCT - Few pts enrolled Abolghasemi et al 36 Case-control study/Iran 115 COVID-19 patients/74 COVID-19 patients - A reduction in all-cause mortality and length of hospitalization was observed in CP-treated group.…”

Coronavirus 2019 Infectious Disease Epidemic: Where We Are, What Can Be Done and Hope For

“…Patients treated with plasma in the early phases of COVID-19, before they required ventilation, fared better than those that were not treated or treated once on a respirator. 163 This seems related to the inactivation of SARS-CoV-2 by antibodies during the early stages of the respiratory disease, before patients develop widespread COVID-19-related damage, including lung consolidation. In summary, plasma therapy is considered safe, although adverse effects may occur; therefore, the U.S. Food and Drug Administration (FDA) has recently approved its use as an emergency treatment for patients with COVID-19.…”

“…Moreover, the efficacy of the plasma and the antibody titer changes from donor to donor. 163 Several companies are preparing hyperimmune globulins obtained by pooling the blood of hundreds of convalescent patients with COVID-19 and by a 10-fold concentration of antibodies. These preparations should be more effective while at the same time reducing the risk of adverse reactions, including transfusion-associated circulatory overload or transfusion-associated acute lung injury.…”