PAP-COVID: Early CPAP in COVID-19 Confirmed or Suspected Patients

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Terminated

CT.gov ID

NCT04390191

Collaborator

Itamar Medical LTD (Other), Community Surgical Supply of Toms River, Inc (Other), Philips Healthcare (Industry)

Enrollment

Location

Arms

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 COVID Coronavirus	Device: Continuous Positive Airway Pressure	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Early Continuous Positive Airway Pressure (CPAP) in COVID-19 Confirmed or Suspected Patients

Actual Study Start Date :

May 7, 2020

Actual Primary Completion Date :

Feb 18, 2021

Actual Study Completion Date :

Jul 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Continuous Positive Airway Pressure (CPAP) Patients will be given CPAP at fixed pressure of 8-10 cm water pressure for 72 hours continuously	Device: Continuous Positive Airway Pressure 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). Other Names: CPAP
No Intervention: Control Patients in this arm will be not be given any intervention and will be monitored for 72 hours continuously, and then daily for a total of 14 days.

Arm

Intervention/Treatment

Experimental: Continuous Positive Airway Pressure (CPAP)

Patients will be given CPAP at fixed pressure of 8-10 cm water pressure for 72 hours continuously

Device: Continuous Positive Airway Pressure

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).

Other Names:

CPAP

No Intervention: Control

Patients in this arm will be not be given any intervention and will be monitored for 72 hours continuously, and then daily for a total of 14 days.

Outcome Measures

Primary Outcome Measures

Efficacy Endpoint composite score [14 days]
Non-weighted composite score comprised of the following components: All-cause mortality within 14 days of randomization, hospital Admission (including ED visit) within 14 days of randomization, oxygen saturation less than 90 during the 72-hour observation period from randomization, absolute reduction in oxygen saturation of more than 4% during the 72-hour observation period from randomization.

Secondary Outcome Measures

Time to ICU admission [14 days from randomization]
The time from randomization to an admission to the intensive care unit within 14 days from randomization
Time to Intubation and mechanical ventilation [14 days from randomization]
The time from randomization to the patient needing to be intubated and needing mechanical ventilation within 14 days from randomization
14 day and 28 day mortality [14-28 days from randomization]
The time from randomization to death within 14 and 28 days from randomization
Conversion rate of COVID household members in CPAP vs control [14 days from randomization]
The conversation rate of household members from being COVID negative to COVID positive in the CPAP arm vs the control arm within 14 days from randomization
Clinical COPD Questionnaire (CCQ) [14 days from randomization]
If there is any improvement in respiratory symptoms of cough or shortness of breath etc. assessed via a respiratory symptom questionnaire within 14 days from randomization. The CCQ is a 10-item instrument, full scale from 0 to 6, with higher score indicating lower health status.
Percentage of patients electing to continue CPAP for greater than 72 hours [7 days from randomization]
Percentage of the patients in the CPAP arm elect to continue using the CPAP after the initial 72 hour period.
Degree of improvement in oxygen saturation [14 days from randomization]
The degree of improvement in oxygen saturation within 14 days of randomization.
Time to hospital admission or ED [14 days from randomization]
Time to hospital admission or ED within 14 days of randomization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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))