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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
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
Municipal Hospital "Dr. Teodor Andrei" Lugoj
Lugoj, Timiș County, Romania
Survival
Number of Participants who Survived
Time frame: 30 day period
P/F Ratio
Average Partial pressure of arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio - P/F ratio calculated between the values from day 1 and day 7
Time frame: 7 day period
C Reactive Protein (CRP)
Average value of CRP calculated using the values from day 1 and day 7
Time frame: 7 day period
Lactate Dehydrogenase (LDH)
Average value of LDH calculated using the values from day 1 and day 7
Time frame: 7 day period
Ferritin
Average value of ferritin calculated using the values from day 1 and day 7
Time frame: 7 day period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.