Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Respiratory Distress Syndrome
- Sponsor
- Novacescu Alexandru
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Survival
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Novacescu Alexandru
Director of trial - Supervisor
University of Medicine and Pharmacy "Victor Babes" Timisoara
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
Outcomes
Primary Outcomes
Survival
Time Frame: 30 day period
Number of Participants who Survived
Secondary Outcomes
- P/F Ratio(7 day period)
- Lactate Dehydrogenase (LDH)(7 day period)
- Ferritin(7 day period)
- C Reactive Protein (CRP)(7 day period)