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

Study identification

• EU PAS number:
  EUPAS34490
• Study ID:
  34491
• Official title and acronym:
  COVID-19: Risk Factors Associated with Respiratory Support Needs in Patients with Viral Disease (COVID-19: US Ventilator Use)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Epidemiologic characteristics suggest that 14% cases affected by the coronavirus disease 2019 (COVID-19) are severe, and 5% critical. Management of severe COVID-19 patients is consistent with that provided to patients with viral pneumonia causing respiratory failure and includes lung-protective ventilation strategies and possible mechanical ventilation. Whereas there is significant experience in treatment of severe acute respiratory failure (SARF), the risk factors for SARF are not well characterized. A recent study looked at a composite value of 5 variables (age, dehydration, respiratory failure, orientation, blood pressure) to predict risk for mortality and requirement for mechanical ventilation. This relatively small study was followed by a few studies evaluating risk factors for pneumonia. However, we are not aware of any large population-based study designed to identify risk factors for SARF and/or need for mechanical ventilation. This study is therefore design to identify key patient variables, known at time of admission, as well as medication and procedure use during hospitalization, that may predict risk for need for mechanical ventilation and mortality.The rationale for conducting this study is as follows: due to the potentially large COVID-19 population requiring ventilation support, there is a risk that the US healthcare system might be overwhelmed. Models to help understand patients at greater risk for increased healthcare needs or mortality may thus help with policy planning, decisions and treatment.This study will be conducted using the Mercy Electronic Healthcare Data - This data is uniquely fit for purpose as it contains, among other common variables, information such as spirometry data, detailed vitals, exact time when ventilator use is ordered and started.
• Study status:
  Planned

Research institutions and networks

Institutions

Mercy Healthcare System

Study timelines

Date when funding contract was signed

Planned:23/03/2020

Actual:23/03/2020

Study start date

Planned:23/03/2020

Date of final study report

Planned:31/05/2020

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Johnson & Johnson, MERCY Healthcare System

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable