Matched Cohort Study of Convalescent COVID-19 Plasma (CCP) Treatment in Severely or Life Threateningly Ill COVID-19 Patients

Klapholz, Marc; Pentakota, Sri Ram; Zertuche, Juan-Pablo; McKenna, Marshall; Roque, Willy; Forsberg, Mark; Packer, Johnathan; Lal, Devika S; Dever, Lisa

BACKGROUND: The utility of convalescent COVID-19 plasma (CCP) in the current pandemic is not well defined. We sought to evaluate safety and efficacy of CCP in severely or life threateningly ill COVID-19 patients when matched with a contemporaneous cohort. METHODS: Patients with severe or life threatening COVID-19 were treated with CCP according to FDA criteria, prioritization by an interdisciplinary team and based on CCP availability. Individual-level matched controls (1:1) were identified from patients admitted during the prior month when no CCP was available. Safety outcome was freedom from adverse transfusion reaction and efficacy outcome a composite of death or worsening O2 support. Demographic, clinical and laboratory data were analyzed by univariate and multivariable regression analyses accounting for matched design. RESULTS: Study patients (N=94, 47 matched pairs) were 62% male with mean age of 58 and 98% (90/94) were minority (53% Hispanic, 45% Black, non-Hispanic) in our inner-city population. Seven-day composite and mortality outcomes suggested a non-significant benefit in CCP treated patients (adjusted hazard ratio (aHR), 0.70; 95% confidence interval (CI), 0.23 to 2.12; P=0.52; aHR, 0.23; 95% CI, 0.04 to 1.51; P=0.13, respectively). Stratification by pre-transfusion mechanical ventilation status showed no differences between groups. No serious transfusion reactions occurred. CONCLUSION: In this short-term matched cohort study, transfusion with CCP was safe and showed a non-significant association with study outcomes. Randomized and larger trials to identify appropriate timing and dosing of CCP in COVID-19 is warranted. Trial Registration: ClinicalTrials.gov Identifier: NCT04420988