Clinical trial NCT04390191: Early CPAP in COVID-19 Confirmed or Suspected Patients
Official title: Early Continuous Positive Airway Pressure (CPAP) in COVID-19 Confirmed or Suspected Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COVID-19
COVID
Coronavirus
Keywords: Continuous Positive Airway Pressure
COVID-19
Coronavirus
Positive airway pressure
Hospital admission
Non-invasive ventilation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Itamar-Medical, Israel
name: Community Surgical Supply of Toms River, Inc
name: Philips Healthcare
First posted: 2020-05-15
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, single-center, parallel group, open-label, randomized clinical trial, where the study team will investigate the efficacy of continuous positive airway pressure therapy (CPAP) in COVID suspected or confirmed patients who are sent home from the emergency room with mild pneumonia or respiratory illness but who do not require hospital admission. 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.
Primary purpose: TREATMENT

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. 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.

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 proposal is to determine if early use of CPAP at home will reduce hypoxemic events or reduce the need for hospital admission or death in COVID-19 suspected or confirmed patients. The study team will include adult patients (age\>18) who live alone or have more than one bedroom at home, with serologically confirmed or suspected COVID-19 infection, who have one or more of the following: fever (\>38ºC), sore throat, myalgia or flu-like illness AND have one or more of the following additional symptom or diagnostic criteria: abnormal chest x-ray, new onset cough, mild hypoxemia at rest (saturation less than 96%), abnormal lung exam, chest tightness or shortness of breath AND who are without need for hospital admission. Patients with preexisting pulmonary diseases such as advanced COPD, advanced parenchymal lung disease, history of pneumothorax etc. will be excluded. Participants in both arms will be shipped a pulse oximeter to monitor oxygen saturation and a disposable home sleep apnea monitor (WatchPAT) to track blood oxygen level continuously for 12 hours with data feed into a cloud based platform. Additionally, 100 patients will be randomized to receive CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc). The CPAP pressure will be adjusted based on patient's comfort but will not deviate from the range of 8-10cm. While the study protocol will end at 72 hours, patients who wish to continue CPAP will be allowed to do so for symptomatic benefit up to 7 days from randomization. All CPAP recipients will be given a full-face mask and will be asked to stay in quarantine for the duration of the protocol to avoid risk of infecting family members with aerosol (separate consent to be obtained from household members who are elderly or with comorbidities.) The study team hypothesizes that early low-grade fixed CPAP in COVID infected patients who have respiratory abnormalities will reduce hypoxemic events and decrease the risk of subsequent hospitalization or death in 14 days from randomization. The study will also address whether use of CPAP in the home increases the risk of infecting household family members.

Eligibility criteria: 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))

Primary outcomes:
measure: Number of Participants Who Met the Efficacy Endpoint
timeFrame: 14 days
Secondary outcomes:
measure: Number of Participants Admitted to the ICU
timeFrame: 14 days from randomization
measure: Time to Intubation and Mechanical Ventilation
timeFrame: 14 days from randomization
measure: Number of Deaths at 14 Day and 28 Day Mortality
timeFrame: 14-28 days from randomization
measure: Conversion of COVID Household Members in CPAP vs Control
timeFrame: 14 days from randomization
measure: Change in Clinical COPD Questionnaire (CCQ)
timeFrame: baseline and 14 days from randomization
measure: Number of Patients Electing to Continue CPAP for Greater Than 72 Hours
timeFrame: 7 days from randomization
measure: Number of Participants With Improvement in Oxygen Saturation
timeFrame: 14 days from randomization
measure: Number of Participants With Hospital Admission or ED
timeFrame: 14 days from randomization
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Neomi Shah, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References: