NCT04973488

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

August 26, 2024

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

July 20, 2021

Results QC Date

November 29, 2022

Last Update Submit

August 1, 2024

Conditions

COVID-19 PneumoniaCOVID-19 Respiratory InfectionAcute Respiratory FailureAcute Respiratory Distress Syndrome

Keywords

Therapeutic Plasma ExchangeConvalescent Plasma

Outcome Measures

Primary Outcomes (1)

  • Survival

    Number of Participants who Survived

    30 day period

Secondary Outcomes (4)

  • P/F Ratio

    7 day period

  • C Reactive Protein (CRP)

    7 day period

  • Lactate Dehydrogenase (LDH)

    7 day period

  • Ferritin

    7 day period

Study Arms (2)

Treatment arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

In the control arm, patients will receive standard COVID-19 treatment

Interventions

Therapeutic plasma exchangeOTHER

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

Also known as: Transfusion of convalescent plasma
Treatment arm

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • positive reverse transcriptase PCR test for COVID 19
  • COVID-19 pneumonia
  • All patients included were adults (\>18 years)
  • Acute respiratory failure

You may not qualify if:

  • pregnant women
  • patients with suspected or confirmed pulmonary embolism
  • patients with terminal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Municipal Hospital "Dr. Teodor Andrei" Lugoj

Lugoj, Timiș County, 305500, Romania

Location

Related Publications (1)

  • 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.

    PMID: 34934447DERIVED

Related Links

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeuticsPlasmapheresisBlood Component RemovalSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Limitations and Caveats

Limitations of the study include the small number of patients enrolled and the non-randomized nature of the study. Also antibody titer was not determined in patients prior to the treatment.

Results Point of Contact

Title
Dr. Novacescu Alexandru
Organization
University of Medicine and Pharmacy "Victor Babes" Timisoara
novacescu_alex@yahoo.com
+40745064844

Study Officials

  • Monica Licker, MD, PhD

    University of Medicine and Pharmacy "Victor Babes" Timisoara

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Not masked
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single group, that is divided into two arms
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of trial - Supervisor

Study Record Dates

First Submitted

July 20, 2021

First Posted

July 22, 2021

Study Start

July 25, 2020

Primary Completion

January 10, 2021

Study Completion

January 10, 2021

Last Updated

August 26, 2024

Results First Posted

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will become available at 6 months after registering the study. It will be available for 36 months
Access Criteria
Data will be shared with interested researchers, contact: novacescu\ alex@yahoo.com

Locations

RO(1)