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

July 20, 2021 updated by: Novacescu Alexandru
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Timis
      • Lugoj, Timis, Romania, 305500
        • Municipal Hospital "Dr. Teodor Andrei" Lugoj

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment arm
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
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
Other Names:
  • Transfusion of convalescent plasma
NO_INTERVENTION: Control arm
In the control arm, patients will receive standard COVID-19 treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 30 day period
In percentage
30 day period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partial pressure of arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio (P/F ratio)
Time Frame: 7 day period
Evolution of ratio
7 day period
C reactive protein (CRP)
Time Frame: 7 day period
Evolution of value
7 day period
Lactate dehydrogenase (LDH)
Time Frame: 7 day period
Evolution of value
7 day period
Ferritin
Time Frame: 7 day period
Evolution of value
7 day period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novacescu Alexandru

Collaborators

University of Medicine and Pharmacy "Victor Babes" Timisoara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 25, 2020

Primary Completion (ACTUAL)

January 10, 2021

Study Completion (ACTUAL)

January 10, 2021

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (ACTUAL)

July 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDYTPECVP20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan on sharing treatment protocol, demographic data of the study cohort, primary outcomes, secondary outcomes, miscellaneous data, treatment scheme, statystical data

IPD Sharing Time Frame

Data will become available at 6 months after registering the study. It will be available for 36 months

IPD Sharing Access Criteria

Data will be shared with interested researchers, contact: novacescu_alex@yahoo.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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