NCT04383678

Brief Summary

This study aims to investigate outcomes and predictors of outcome after extracorporeal membrane oxygenation (ECMO) therapy for severe acute respiratory syndrome (ARDS) in COVID-19 patients.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
6 countries

11 active sites

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

March 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

May 7, 2020

Last Update Submit

April 17, 2021

Conditions

COVID-19Extracorporeal Membrane Oxygenation ComplicationAcute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

    All-cause mortality

    Immediately after the intervention/procedure/surgery

Secondary Outcomes (12)

  • Death on ECMO

    During the intervention/procedure/surgery

  • Stroke

    Immediately after the intervention/procedure/surgery

  • Blood stream infection

    Immediately after the intervention/procedure/surgery

  • Lung complications requiring surgical treatment

    Immediately after the intervention/procedure/surgery

  • Blood transfusion

    Immediately after the intervention/procedure/surgery

  • +7 more secondary outcomes

Study Arms (1)

COVID-19 positive patients

Device: Extracorporeal membrane oxygenation

Interventions

Extracorporeal membrane oxygenationDEVICE

Veno-venous or veno-arterial extracorporeal oxygenation

COVID-19 positive patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with PCR-confirmed or suspected COVID-19 infection with ARDS who require veno-venous or veno-arterial ECMO therapy

You may qualify if:

  • PCR-confirmed or suspected COVID-19 infection with ARDS who require any ECMO therapy

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Helsinki University Hospital

Helsinki, Finland

Location

University Hospital Jean Minjoz

Besançon, France

Location

Nancy University Hospital

Nancy, France

Location

Henri Mondon Unoversity Hospital

Paris, France

Location

Robert Debré University Hospital

Reims, France

Location

Hamburg University Heart Center

Hamburg, Germany

Location

Münster University Hospital

Münster, Germany

Location

S. Orsola Hospital

Bologna, Italy

Location

Lecco Hospital

Lecco, Italy

Location

Karolinska University Hospital

Stockholm, Sweden

Location

University Hospitals of Leicester

Leicester, United Kingdom

Location

Related Publications (1)

  • Biancari F, Mariscalco G, Dalen M, Settembre N, Welp H, Perrotti A, Wiebe K, Leo E, Loforte A, Chocron S, Pacini D, Juvonen T, Broman LM, Perna DD, Yusuff H, Harvey C, Mongardon N, Maureira JP, Levy B, Falk L, Ruggieri VG, Zipfel S, Folliguet T, Fiore A. Six-Month Survival After Extracorporeal Membrane Oxygenation for Severe COVID-19. J Cardiothorac Vasc Anesth. 2021 Jul;35(7):1999-2006. doi: 10.1053/j.jvca.2021.01.027. Epub 2021 Jan 19.

    PMID: 33573928DERIVED

MeSH Terms

Conditions

COVID-19Respiratory Distress Syndrome

Interventions

Extracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Fausto Biancari, Professor

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 12, 2020

Study Start

March 1, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)FR(4)FI(1)GB(1)DE(2)IT(2)