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Updated: Dec 20, 2025
Lung Rapid Recovery Procurement Combined with Abdominal Normothermic Regional Perfusion in Controlled Donation after Circulatory Death
Published on: August 15, 2022
Plasma from donors recovered from the new Coronavirus 2019 as therapy for critical patients with COVID-19 (COVID-19
Cesare Perotti1, Claudia Del Fante2, Fausto Baldanti3,4
1Immunohematology and Transfusion Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Insights
This study assessed hyperimmune plasma infusion for critically ill COVID-19 patients. While limited by a small sample size, results may inform future large-scale clinical trials on convalescent plasma therapy for SARS-CoV-2.
Area of Science:
- Infectious Diseases
- Hematology
- Critical Care Medicine
Background:
- The emergence of SARS-CoV-2 (COVID-19) in late 2019 led to a global epidemic.
- Italy reported its first domestic COVID-19 transmission in February 2020, with significant case numbers by March 2020.
- Limited evidence existed regarding the efficacy of hyperimmune plasma for COVID-19 treatment during the early pandemic.
Purpose of the Study:
- To evaluate the efficacy of hyperimmune plasma infusion from COVID-19 convalescent donors in critically ill patients.
- To assess the impact of this therapy on patient survival, considering death from any cause as the primary endpoint.
- To lay the groundwork for future, larger clinical trials based on proof-of-concept findings.
Main Methods:
- A one-arm, proof-of-concept clinical trial design was employed.
- The study involved the administration of plasma from convalescent COVID-19 donors to critically ill patients.
- Patient survival was the primary outcome measure, with 43 patients enrolled.
Main Results:
- The abstract does not contain specific results, but indicates the study's primary objective was to evaluate efficacy and survival.
- The study's proof-of-concept nature and small sample size (43 patients) are noted as limitations.
- The findings are intended to inform the design of subsequent, larger clinical trials.
Conclusions:
- The study aimed to provide initial evidence on the feasibility and efficacy of hyperimmune plasma for severe COVID-19.
- Given the lack of prior data, a one-arm trial was deemed ethically justifiable.
- Encouraging results could pave the way for more robust randomized controlled trials in the future.
Abstract:
Since the end of 2019, a new coronavirus strain has been reported in the Chinese province of Wuhan, indicated as 2019-nCoV or SARS-CoV-2. In February 2020, the first case of transmission on Italian soil was reported. On March 09, 2020, at the time of protocol design, the Italian Ministry of Health reported 10,149 people who had contracted the virus; of these, 8514 were positive, of which 5038 were hospitalized with symptoms (59.2%) and 877 in intensive care (10.3%), while the remaining 2599 were in home isolation; 631 were deceased (6.2%) and 1004 healed (9.9%). To date there are no studies in the literature that demonstrate its feasibility and efficacy in the context of the worldwide SARS-CoV-2 epidemic. Based upon the little existing evidence, we planned to assess the efficacy of the infusion of hyperimmune plasma in COVID-19 patients in a one-arm proof-of-concept clinical trial. The primary objective of our study is to evaluate the efficacy of the administration of plasma taken from convalescent donors of COVID-19 to critically ill patients with COVID-19 in terms of their survival. Death from any cause will be considered. The main limit of this study is its one-arm proof-of-concept design with only 43 patients enrolled. However, in the absence of previous evidence, larger and/or randomized trials did not appear to be ethically acceptable. Moreover, the results from this study, if encouraging, will allow us to plan further informed large clinical trials. Trial registration: NCT04321421 March 23, 2020.
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