Transfusion reactions associated with COVID‐19 convalescent plasma in outpatient clinical trials

Abstract

BackgroundCOVID‐19 convalescent plasma (CCP) is an important therapeutic option for outpatients at high risk of hospitalization from SARS‐CoV‐2 infection. We assessed the safety of outpatient CCP transfusions administered during clinical trials.Study Design and MethodsWe analyzed data pertaining to transfusion‐related reactions from two randomized controlled trials in the U.S. that evaluated the efficacy of CCP versus control plasma in various ambulatory settings. Multivariable logistic regression was used to assess whether CCP was associated with transfusion reactions, after adjusting for potential confounders.ResultsThe combined study reported 79/1351 (5.9%) adverse events during the transfusion visit, with the majority 62/1351 (4.6%) characterized by mild, allergic‐type findings of urticaria, and/or pruritus consistent with minor allergic transfusion reactions; the other reported events were attributed to the patients' underlying disease, COVID‐19, or vasovagal in nature. We found no difference in the likelihood of allergic transfusion reactions between those receiving CCP versus control plasma (adjusted odds ratio [AOR], 0.75; 95% CI, 0.43–1.31). Risk of urticaria and/or pruritus increased with a pre‐existing diagnosis of asthma (AOR, 2.33; 95% CI, 1.16–4.67). We did not observe any CCP‐attributed antibody disease enhancement in participants with COVID‐19 or increased risk of infection. There were no life‐threatening severe transfusion reactions and no patients required hospitalization related to transfusion‐associated complications.DiscussionOutpatient plasma administration was safely performed for nearly 1400 participants. CCP is a safe therapeutic option for outpatients at risk of hospitalization from COVID‐19.

Hyperimmune Plasma and Immunoglobulins against COVID-19: A Narrative Review

“…Additional concerns were initially raised, such as antibody-dependent enhancement (ADE) of viral infection, and transfusion reactions. All those concerns have remained theoretical so far, and several systematic reviews and metanalyses have found no increased risk compared with transfusion of fresh frozen plasma [16]. An additional concern regards the occurrence of venous and arterial thrombotic adverse events related to CCP transfusion, an issue not so trivial considering the highly prothrombotic context of COVID-19 and the presence of procoagulant factors in fresh frozen plasma.…”

The Role of Convalescent Plasma in COVID-19: A Conclusive Post-Pandemic Review

“…Additional concerns were initially raised, such as antibody-dependent enhancement (ADE) of viral infection and transfusion reactions. All of those concerns have remained theoretical so far, and several systematic reviews and metanalysis have found no increased risk compared to transfusion of fresh frozen plasma [13,14]. An additional concern is the occurrence of venous and arterial thrombotic adverse events related to CCP transfusion, an issue not so trivial considering the highly prothrombotic context of COVID-19 and the presence of procoagulant factors in fresh frozen plasma [12].…”

Hyperimmune Plasma and Immunoglobulins Against COVID-19: A Narrative Review

“…Additional concerns were initially raised, such as antibody-dependent enhancement (ADE) of viral infection, and transfusion reactions. All those concerns have remained theoretical so far, and several systematic reviews and metanalyses have found no increased risk compared to transfusion of fresh frozen plasma [20,21]. An additional concern regards the occurrence of venous and arterial thrombotic adverse events related to CCP transfusion, an issue not so trivial considering the highly prothrombotic context of COVID-19 and the presence of procoagulant factors in fresh frozen plasma [16].…”