Clinical trial NCT04973488: Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients
Official title: Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Pneumonia
COVID-19 Respiratory Infection
Acute Respiratory Failure
Acute Respiratory Distress Syndrome
Keywords: Therapeutic Plasma Exchange
Convalescent Plasma
Lead sponsor: University of Medicine and Pharmacy "Victor Babes" Timisoara
Sponsor class: OTHER
Collaborators: name: University of Medicine and Pharmacy "Victor Babes" Timisoara
First posted: 2021-07-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single group, that is divided into two arms
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* positive reverse transcriptase PCR test for COVID 19
* COVID-19 pneumonia
* 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

Primary outcomes:
measure: Survival
timeFrame: 30 day period
Secondary outcomes:
measure: P/F Ratio
timeFrame: 7 day period
measure: C Reactive Protein (CRP)
timeFrame: 7 day period
measure: Lactate Dehydrogenase (LDH)
timeFrame: 7 day period
measure: Ferritin
timeFrame: 7 day period
Other outcomes:
Locations:
city: Lugoj
country: Romania
facility: Municipal Hospital "Dr. Teodor Andrei" Lugoj
state: Timis
Study officials:
affiliation: University of Medicine and Pharmacy "Victor Babes" Timisoara
name: Monica Licker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.