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Plasma Exchange (PLEX) and Convalescent Plasma (CCP) in COVID-19 Patients With Multiorgan Failure

NCT04634422 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2020-12-21

No results posted yet for this study

Summary

This Randomized Control Trial (RCT) proposes combination of extracorporeal cytokine removal by plasma exchange (PLEX) and additional infusion of convalescent plasma (CCP) collected from COVID-19 recovered individuals at the end of the PLEX procedure. The combination of cytokine removal by PLEX and CCP infusion is in onvestigators opinion more rational compared to CCP infusion alone and as such probably more effective in reducing the duration of mechanical ventilation, length of stay in the intensive care unit, and potentially also mortality.

Conditions

Interventions

PROCEDURE

Plasma exchange and convalescent plasma

In addition to standard care, participants will receive 2 plasma exchange procedures max. 30 hours apart using the membrane or centrifuge method. PLEX will be initiated within 30 hours of randomization. The exchange volume of 60 mg of plasma per kg body weight will be substituted with albumin 5% and Ringer/saline 50% at the beginning followed by 50% FFP towards the end of the procedure. At the end of the 2nd procedure, participants will receive additional 2 units of CCP (equalling 600 ml CCP) with an administration rate of 100 to 250 ml/hr. Anticoagulation may be provided by citrate or by heparin but it is suggested that in patients with active bleeding regional citrate anticoagulation be utilized. PLEX may be performed via a central venous catheter if patient is deemed unsuitable for peripheral venous access, the latter is recommended. Possible SAE related to PLEX+CCP will be recorded as air embolism, anaphylaxis, TRALI and reported as an outcome.

Sponsors & Collaborators

  • Aalborg University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Zealand University Hospital

    collaborator OTHER

  • Wladimir Szpirt

    lead OTHER

Principal Investigators

  • Anders Perner, Prof · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2021-06-30
Completion
2022-06-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04634422 on ClinicalTrials.gov