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Early Safety Indicators of COVID-19 ConvalescentPlasma in 5,000 Patients
Preprint
en En
| PREPRINT-MEDRXIV
| ID: ppmedrxiv-20099879
ABSTRACT
BackgroundConvalescent plasma is the only antibody based therapy currently available for COVID-19 patients. It has robust historical precedence and sound biological plausibility. Although promising, convalescent plasma has not yet been shown to be safe as a treatment for COVID-19. MethodsThus, we analyzed key safety metrics after transfusion of ABO-compatible human COVID-19 convalescent plasma in 5,000 hospitalized adults with severe or life-threatening COVID-19, with 66% in the intensive care unit, as part of the US FDA Expanded Access Program for COVID-19 convalescent plasma. ResultsThe incidence of all serious adverse events (SAEs) in the first four hours after transfusion was <1%, including mortality rate (0.3%). Of the 36 reported SAEs, there were 25 reported incidences of related SAEs, including mortality (n=4), transfusion-associated circulatory overload (TACO; n=7), transfusion-related acute lung injury (TRALI; n=11), and severe allergic transfusion reactions (n=3). However, only 2 (of 36) SAEs were judged as definitely related to the convalescent plasma transfusion by the treating physician. The seven-day mortality rate was 14.9%. ConclusionGiven the deadly nature of COVID-19 and the large population of critically-ill patients included in these analyses, the mortality rate does not appear excessive. These early indicators suggest that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19. Brief SummaryAfter transfusion of COVID-19 convalescent plasma in 5,000 patients, the incidence of serious adverse events was <1% and the seven-day incidence of mortality was 14.9%.
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Texto completo:
1
Colección:
09-preprints
Base de datos:
PREPRINT-MEDRXIV
Tipo de estudio:
Observational_studies
Idioma:
En
Año:
2020
Tipo del documento:
Preprint