Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients

Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients

Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients

Therapeutic plasma exchange (TPE) has been proposed as a rescue therapy in critically ill COVID-19 patients. The aim of this study is to determine whether combining TPE with convalescent plasma (CVP) transfusion early during the intensive care unit (ICU) stay, improves survival among this heterogeneous population.

This single centre prospective, non-randomised controlled trial will be conducted in an 8 bed COVID-19 ICU and will include patients with severe COVID-19 pneumonia requiring ICU monitoring and therapy. 19 patients will be treated performing TPE followed by CVP transfusion while for 19 patients will receive standard treatment according to hospital protocols. TPE will be initiated during the first 24 hours after ICU admission, followed immediately by transfusion of CVP. The primary endpoint is survival at 30 days. Secondary endpoints include assessing the evolution of biomarkers, such as the partial pressure of arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio (P/F ratio), C reactive protein (CRP), lactate dehydrogenase (LDH) and ferritin at the 7-day follow-up.

COVID-19 Pneumonia, COVID-19 Respiratory Infection, Acute Respiratory Failure, Acute Respiratory Distress Syndrome

In the treatment arm, Therapeutic plasma exchange will be conducted in the first 24 hours after being admitted into the intensive care unit, after which convalescent plasma from donors that have had COVID-19 will be transfused

The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19

Inclusion Criteria: positive reverse transcriptase PCR test for COVID 19 All patients included were adults (>18 years) Acute respiratory failure Exclusion Criteria: pregnant women patients with suspected or confirmed pulmonary embolism patients with terminal disease

We plan on sharing treatment protocol, demographic data of the study cohort, primary outcomes, secondary outcomes, miscellaneous data, treatment scheme, statystical data

Data will become available at 6 months after registering the study. It will be available for 36 months

Novacescu AN, Duma G, Buzzi B, Baditoiu LM, Bedreag O, Papurica M, Sandesc D, Sorescu T, Vlad D, Licker M. Therapeutic plasma exchange followed by convalescent plasma transfusion in severe and critically ill COVID-19 patients: A single centre non-randomized controlled trial. Exp Ther Med. 2022 Jan;23(1):76. doi: 10.3892/etm.2021.10999. Epub 2021 Nov 24.

COVID-19 Treatment Guidelines Panel. Coronavirus disease 2019 (COVID-19) treatment guidelines. National Institutes of Health

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