Clinical Scores for Outcome Prediction in Patients With Severe COVID-19 Pneumonia Requiring ECMO

NCT04405973 | Completed

• 1 other identifier: EK-FR 329/20
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

The prognosis of patients with severe COVID-19 disease, whose lungs are so severely diseased that they need to be supported by veno-venous ECMO (extracorporeal membrane oxygenation), is difficult to assess so far. Previously published data from studies, case reports and case series describe a very high mortality in this patient collective. The significance of established clinical prognostic cores in this patient population has not been systematically investigated. This is aggravated by the fact that even at very specialized centers only very few patients from this collective are (can be) treated, so that valid investigations are only possible in a multicenter patient collective. In this registry study, all patients diagnosed with COVID-19 and treated with vv-ECMO in the centers participating in the study should be retrospectively examined. The primary aim of the study is to investigate 30-day survival, secondary objectives include the analysis of different clinical scores at the time of ECMO implantation.

Conditions

COVID-19; SARS-CoV 2; Extracorporeal Membrane Oxygenation; ARDS

Keywords

ECMO; ARDS; COVID-19

Outcome Measures

Primary Outcomes (1)

• overall survival

  time from ECMO-implantation to death

  30 days

Secondary Outcomes (3)

• duration of ECMO treatment

  30 days

• duration of ventilation treatment

  30 days

• duration of initiation of ECMO treatment to ICU discharge

  30 days

Study Arms (1)

COVID-19 ARDS, vv-ECMO

All patients in the study centers with diagnosed COVID-19 infection (PCR proven) and treatment with vv-ECMO

Device: vv-ECMO

Interventions

vv-ECMO DEVICE

vv-ECMO required in severe COVID-19 ARDS

COVID-19 ARDS, vv-ECMO

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All COVID-19-patients treated on an ICU at the participating centers and requeiring vv-ECMo support

You may qualify if:

• patient admitted to ICU
• initiation of vv-ECMO
• definite SARS-CoV-2-infection

You may not qualify if:

• none

Sponsors & Collaborators

• Dr. Alexander Supady: lead

Study Sites (1)

University Clinic Freiburg

Freiburg im Breisgau, 79106, Germany

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alexander Supady, MD, MPH

  University Clinic Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician - Oberarzt

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: May 28, 2020
• Study Start: May 19, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)