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

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome; Acute Respiratory Failure; COVID-19 Pneumonia; COVID-19 Respiratory Infection
• Interventions: Other: Therapeutic plasma exchange

• Registration Number: NCT04973488
• Lead Sponsor: Novacescu Alexandru

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.

Study Timeline

• Study Start: 2020-07-25
• Primary Completion: 2021-01-10
• Study Completion: 2021-01-10
• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-22
• Results First Submitted: 2022-11-29
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-01
• Last Update Submitted: 2024-08-01
• Results First Posted: 2024-08-26
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment arm	Therapeutic plasma exchange	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

Primary Outcome Measures

Name	Time	Method
Survival	30 day period	Number of Participants who Survived

Secondary Outcome Measures

Name	Time	Method
Lactate Dehydrogenase (LDH)	7 day period	Average value of LDH calculated using the values from day 1 and day 7
P/F Ratio	7 day period	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
Ferritin	7 day period	Average value of ferritin calculated using the values from day 1 and day 7
C Reactive Protein (CRP)	7 day period	Average value of CRP calculated using the values from day 1 and day 7

Trial Locations

Locations (1)

Municipal Hospital "Dr. Teodor Andrei" Lugoj; 🇷🇴 Lugoj, Timis, Romania