Clinical Scores for Outcome Prediction in Patients With Severe COVID-19 Pneumonia Requiring ECMO
Condition: COVID-19; SARS-CoV 2; Extracorporeal Membrane Oxygenation; ARDS
MeSH terms: COVID-19; Pneumonia
Study type: Observational

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.
    

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.
    

Intervention name(s): vv-ECMO
Intervention type(s): Device
Intervention description(s): vv-ECMO required in severe COVID-19 ARDS
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All COVID-19-patients treated on an ICU at the participating centers and requeiring vv-ECMo
        support
      
Keywords: ECMO; ARDS; COVID-19