COVID-19: Risk Factors Associated with Respiratory Support Needs in Patients with Viral Disease (COVID-19: US Ventilator Use)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Progression of disease and risk for device utilization

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Influenza

Population studied

• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  200000

Study design details

• Main study objective:
  Understand risk factors for severe respiratory disease leading to requirement for mechanical ventilator use and ECMO and prolonged mechanical ventilator use and mortality, in patients with influenza, as a proxy for COVID-19.
• Outcomes:
  1) Understand risk factors for severe respiratory disease leading to requirement for mechanical ventilator use and ECMO use that are assessed at the time of first contact with the healthcare systems with a diagnosis of influenza (flu).2) Estimate the incidence of respiratory ventilator use and ECMO use among patients diagnosed with influenza in the Mercy Health population, Understand risk factors for prolonged mechanical ventilator use, ECMO use, and mortality.
• Data analysis plan:
  Logistic models to evaluate risks for ventilator use, extended ventilator use and mortality. If sufficient population size: predictive models.