Status:
TERMINATED
Early CPAP in COVID-19 Confirmed or Suspected Patients
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Itamar-Medical, Israel
Community Surgical Supply of Toms River, Inc
Conditions:
COVID-19
COVID
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
There is surge in COVID infected patients in New York City with a shortage of hospital beds, ICU beds and ventilators. Strategies to reduce the need for all of the above are immediately needed. Furthe...
Detailed Description
The study team proposes a randomized controlled trial of CPAP (n=100) vs. control (n=100) in COVID-19 suspected or confirmed patients with pneumonia or respiratory illness. The overarching aim of this...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adults \> 18 years old
- Patients living alone or with more than one room at home
- COVID confirmed or suspected
- To be discharged home or already discharged
- One or more of these: fever (\>38oC), sore throat, myalgia or flu-like illness
- One or more of the following: abnormal chest x-ray, new onset cough, mild hypoxemia (saturation between 92-96%), abnormal lung exam, chest tightness or shortness of breath
- Exclusion criteria:
- Unable to self quarantine for 72 hours if in the CPAP arm
- Preexisting pulmonary diseases such as advanced COPD, advanced parenchymal lung disease, history of pneumothorax etc.
- Claustrophobic and unable to tolerate CPAP mask
- Evidence of hypercapnia
- Recent heart of lung surgery within 3 months
- Individuals without access to smart phones or wireless connection or internet access
- Prior history of aspiration
- Speech or swallowing impairment (risk of aspiration)
- History of stroke with significant neurologic deficit
- Advanced symptomatic heart failure
- Unable to provide informed consent
- household with young children and child care responsibilities
- household with high-risk individuals (defined as over 60 or with comorbidities (e.g. heart disease, diabetes, pulmonary))
Exclusion
Key Trial Info
Start Date :
May 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04390191
Start Date
May 7 2020
End Date
July 7 2021
Last Update
September 28 2022
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029