BACKGROUND: Convalescent 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. METHODS: Thus, 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. RESULTS: The 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%. CONCLUSION: Given 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.
BACKGROUND: Convalescent plasma is the only antibody based therapy currently available for COVID 19patients. 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. METHODS: Thus, we analyzed key safety metrics after transfusion of ABO compatible humanCOVID-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. RESULTS: The 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%. CONCLUSION: Given the deadly nature of COVID 19 and the large population of critically-illpatients 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.
Authors: Matteo Bassetti; Daniele Roberto Giacobbe; Paolo Bruzzi; Emanuela Barisione; Stefano Centanni; Nadia Castaldo; Silvia Corcione; Francesco Giuseppe De Rosa; Fabiano Di Marco; Andrea Gori; Andrea Gramegna; Guido Granata; Angelo Gratarola; Alberto Enrico Maraolo; Malgorzata Mikulska; Andrea Lombardi; Federico Pea; Nicola Petrosillo; Dejan Radovanovic; Pierachille Santus; Alessio Signori; Emanuela Sozio; Elena Tagliabue; Carlo Tascini; Carlo Vancheri; Antonio Vena; Pierluigi Viale; Francesco Blasi Journal: Infect Dis Ther Date: 2021-07-30
Authors: Guilherme Pessoa-Amorim; Mark Campbell; Lucy Fletcher; Peter Horby; Martin Landray; Marion Mafham; Richard Haynes Journal: Future Healthc J Date: 2021-07
Authors: Sabra L Klein; Andrew Pekosz; Han-Sol Park; Rebecca L Ursin; Janna R Shapiro; Sarah E Benner; Kirsten Littlefield; Swetha Kumar; Harnish Mukesh Naik; Michael J Betenbaugh; Ruchee Shrestha; Annie A Wu; Robert M Hughes; Imani Burgess; Patricio Caturegli; Oliver Laeyendecker; Thomas C Quinn; David Sullivan; Shmuel Shoham; Andrew D Redd; Evan M Bloch; Arturo Casadevall; Aaron Ar Tobian Journal: J Clin Invest Date: 2020-11-02 Impact factor: 14.808