Early CPAP in COVID-19 Confirmed or Suspected Patients

ID#: NCT04390191

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: May 07, 2020

End Date: May 01, 2021

Contact Information:
Neomi Shah, MD, MPH, MS
212-241-6286
Samira Khan, MPH
516-749-6198
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. Further, few interventions are targeted in COVID infected patients early in the course of their disease and especially in the community/home settings. Respiratory decompensation appears to occur later in the disease process (i.e. 7-10 days after becoming symptomatic) therefore many patients are sent home from the Emergency Room and they subsequently decompensate later at home. Some patients die at home and others are returning to the Emergency Room with hypoxemic respiratory failure. There is no treatment offered to this population of patients, i.e. COVID suspected or confirmed and with respiratory symptoms or abnormal chest x-ray at the time of presentation. Based on experience across the globe, these patients are likely to worsen at home. The study team therefore proposes a prospective, single-center, parallel group, open-label, randomized clinical trial to assess the efficacy of fixed low continuous positive airway pressure therapy (CPAP) (FDA approved and often used for treatment of sleep apnea) in COVID confirmed or suspected patients with abnormal chest x-ray or respiratory symptoms who do not require hospital admission and are discharged home from the emergency room.
Eligibility:

Inclusion criteria:

1. Adults > 18 years old

2. Patients living alone or with more than one room at home

3. COVID confirmed or suspected

4. To be discharged home or already discharged

5. One or more of these: fever (>38oC), sore throat, myalgia or flu-like illness

6. 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:

1. Unable to self quarantine for 72 hours if in the CPAP arm

2. Preexisting pulmonary diseases such as advanced COPD, advanced parenchymal lung disease, history of pneumothorax etc.

3. Claustrophobic and unable to tolerate CPAP mask

4. Evidence of hypercapnia

5. Recent heart of lung surgery within 3 months

6. Individuals without access to smart phones or wireless connection or internet access

7. Prior history of aspiration

8. Speech or swallowing impairment (risk of aspiration)

9. History of stroke with significant neurologic deficit

10. Advanced symptomatic heart failure

11. Unable to provide informed consent

12. household with young children and child care responsibilities

13. household with high-risk individuals (defined as over 60 or with comorbidities (e.g. heart disease, diabetes, pulmonary))
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