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

COVID-19 Clinical Trial

Official title:

Clinical Scores for Outcome Prediction in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation - a Retrospective Multi-center Registry Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04405973
• Other study ID #: EK-FR 329/20
• Status: Completed
• Start date: May 19, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2020
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• patient admitted to ICU

• initiation of vv-ECMO

• definite SARS-CoV-2-infection

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• ARDS
• COVID-19
• Extracorporeal Membrane Oxygenation
• Pneumonia
• SARS-CoV 2

Intervention

Device:
• vv-ECMO
vv-ECMO required in severe COVID-19 ARDS

Locations

Country	Name	City	State
Germany	University Clinic Freiburg	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Alexander Supady

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	time from ECMO-implantation to death	30 days
Secondary	duration of ECMO treatment	time from ECMO-implantation to ECMO-explantation	30 days
Secondary	duration of ventilation treatment	time from ECMO-implantation to extubation	30 days
Secondary	duration of initiation of ECMO treatment to ICU discharge	time from ECMO-implantation to ICU-discharge	30 days