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NCT04973488 Clinical Trial

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

Acute Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04973488
Other study ID # STUDYTPECVP20
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date July 25, 2020
Est. completion date January 10, 2021

Study information
Verified date July 2021
Source University of Medicine and Pharmacy "Victor Babes" Timisoara
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date January 10, 2021
Est. primary completion date January 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Therapeutic plasma exchange
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

Locations
Country Name City State
Romania Municipal Hospital "Dr. Teodor Andrei" Lugoj Lugoj Timis

Sponsors (2)
Lead Sponsor Collaborator
Novacescu Alexandru University of Medicine and Pharmacy "Victor Babes" Timisoara

Country where clinical trial is conducted

Romania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival In percentage 30 day period
Secondary Partial pressure of arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio (P/F ratio) Evolution of ratio 7 day period
Secondary C reactive protein (CRP) Evolution of value 7 day period
Secondary Lactate dehydrogenase (LDH) Evolution of value 7 day period
Secondary Ferritin Evolution of value 7 day period
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