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

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ClinicalTrials.gov Identifier: NCT04405973
Recruitment Status : Completed
First Posted : May 28, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Alexander Supady, University Hospital Freiburg

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.

Condition or disease Intervention/treatment
COVID-19 SARS-CoV 2 Extracorporeal Membrane Oxygenation ARDS Device: vv-ECMO

Detailed Description:

In December 2019, a series of unexplained cases of pneumonia in the city of Wuhan in China has come to light. In virologic analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (first named 2019-nCoV, then SARS-CoV-2). The disease spread rapidly in the city of Wuhan in early 2020 and soon beyond. On 30 January 2020, the Director-General of the World Health Organization (WHO) declared the outbreak a public health emergency of international concern, and on 11 March 2020, the World Health Organization declared the virus a pandemic.

In humans, an infection with the virus can cause respiratory tract infections or even very severe pneumonia - these often end fatally, especially in old and pre-diseased patients. Due to the novelty of the virus, the data basis for therapy is very limited. To date, there are no clinical data for an effective specific therapy, nor is there a vaccination against the virus available, so that therapy, especially intensive care treatment for very severe courses, must concentrate only on supportive treatment of lung failure and other complications.

The virus is highly contagious and infection results in a relevant number of deaths. Due to very uncertain data on the spread of the virus in the population, it is difficult to estimate the mortality rate - the case fatality rate is about 4% based on the known case numbers.

In reports on the treatment of the first cases in Wuhan (Hubei Province, China) in January 2020, the need for intensive care treatment is described for about a quarter of the inpatient cases, 10-17% had to be ventilated invasively, and veno-venous extracorporeal membrane oxygenation (vv-ECMO) was necessary in 2-4% of the inpatient cases. Patients requiring ECMO have a high mortality rate in the studies published, so far. Recommendations for initiation of ECMO in COVID-19 are being developed, though under continuous review.

Currently, little is known to guide clinicians in the choice of patients eligible for ECMO in COVID-19, nor about the best time point for initiation of ECMO or the value of established clinical scores for the prediction of the outcome of patients.

The aim of the study is to investigate survival in COVID-19 patients requiring vv-ECMO support. Furthermore, the accuracy of clinical scores, established in intensive care medicine for the prediction of outcome in severely ill patients will be assessed. Finally, time to extubation from ventilation and time to ECMO-explantation will be evaluated. The study design is a single-arm retrospective multi-center registry; therefore, no comparator will be evaluated.

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Study Type : Observational
Actual Enrollment : 133 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Scores for Outcome Prediction in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation - a Retrospective Multi-center Registry Study
Actual Study Start Date : May 19, 2020
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
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
vv-ECMO required in severe COVID-19 ARDS




Primary Outcome Measures :
  1. overall survival [ Time Frame: 30 days ]
    time from ECMO-implantation to death


Secondary Outcome Measures :
  1. duration of ECMO treatment [ Time Frame: 30 days ]
    time from ECMO-implantation to ECMO-explantation

  2. duration of ventilation treatment [ Time Frame: 30 days ]
    time from ECMO-implantation to extubation

  3. duration of initiation of ECMO treatment to ICU discharge [ Time Frame: 30 days ]
    time from ECMO-implantation to ICU-discharge



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All COVID-19-patients treated on an ICU at the participating centers and requeiring vv-ECMo support
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405973


Locations
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Germany
University Clinic Freiburg
Freiburg, Germany, 79106
Sponsors and Collaborators
Dr. Alexander Supady
Investigators
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Principal Investigator: Alexander Supady, MD, MPH University Clinic Freiburg
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Responsible Party: Dr. Alexander Supady, Attending Physician - Oberarzt, University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT04405973    
Other Study ID Numbers: EK-FR 329/20
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Alexander Supady, University Hospital Freiburg:
ECMO
ARDS
COVID-19
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections