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

NCT04634422 | Unknown DMC

• 1 other identifier: H-20041716
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Respiratory Failure; Renal Failure, Acute

Outcome Measures

Primary Outcomes (1)

• Alive at Day 90th

  The primary outcome is days alive and out of hospital from randomisation to day 90.

  90 days

Secondary Outcomes (3)

• Day 8 serious adverse events

  8 days

• Day 28 all cause mortality

  28 days

• Days alive without life support at day 90

  90 days

Study Arms (2)

Plasma Exchange and convalescent Plasma

EXPERIMENTAL

2 plasma exchange procedures within 24 hours and in addition 2 bags of CCP (equalling 600 ml CCP) infused at the end of the 2nd procedure.

Procedure: Plasma exchange and convalescent plasma

Control without intervention

NO INTERVENTION

Standard care without the use of PLEX or convalescent plasma.

Interventions

Plasma exchange and convalescent plasma PROCEDURE

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.

Plasma Exchange and convalescent Plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed SARS-CoV-2 (COVID-19) requiring intensive care AND - Use of Advanced respiratory support as Invasive mechanical ventilation OR Non-invasive ventilation or continuous use of continuous positive airway pressure (CPAP) for hypoxia OR Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system AND RRT (continuous or intermittent) -OR ECMO

You may not qualify if:

• who have received convalescent plasma for COVID-19,
• who have known hypersensitivity to plasma,
• who are pregnant,
• who the clinical team has decided not to escalate therapy (except that for cardiac arrest; patients who are not for cardio-pulmonary-resuscitation may be enrolled).
• Who have received RRT for more than 72 hours
• Who have received mechanical ventilation for more than 14 days
• We will not exclude patients enrolled in other interventional trials unless the protocols of the two trials collide (e.g. use of CCP by protocol). Co-enrolment agreements will be established with the sponsor/investigator to maintain an updated list of trials approved for co-enrolment (

Sponsors & Collaborators

• Wladimir Szpirt: lead
• Aalborg University Hospital: collaborator
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• Zealand University Hospital: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Acute Kidney Injury

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Anders Perner, Prof

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wladimir M Szpirt, MD

CONTACT

4535451767; mail@covid-plex.com

Nicholas Carlson, MD

CONTACT

4535455927; nicholas.carlson.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant

Model Details: Multicentre, parallel-grouped, stratified, centrally randomised controlled trial.

Study Record Dates

• First Submitted: November 14, 2020
• First Posted: November 18, 2020
• Study Start: November 16, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2022
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: June 30st 2024 - June 30st 2029
• Access Criteria: Study Website

Locations

DK (1)