Early CPAP in COVID-19 Confirmed or Suspected Patients (PAP-COVID)

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

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19; COVID; Coronavirus
• Intervention / Treatment: Device: Continuous Positive Airway Pressure

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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))

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Met the Efficacy Endpoint	Number of participants who met the efficacy endpoint within 14 days. The efficacy endpoint is meeting any of the following: 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. If a participant meets any of the events noted in the composite endpoint, it is counted as a worse outcome. The composite endpoints were selected based on available covid-related information at the time of the study design. This study was conducted to determine measures that alleviated hospital burden, allowing patients to be managed at home. Oxygen-related endpoints measure improvement in a home setting and contribute to a higher number of events in the composite outcomes, to provide enough power to measure efficacy in a small trial.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Admitted to the ICU	Number of Participant with an admission to the intensive care unit within 14 days from randomization	14 days from randomization
Time to Intubation and Mechanical Ventilation	The time from randomization to the patient needing to be intubated and needing mechanical ventilation within 14 days from randomization	14 days from randomization
Number of Deaths at 14 Day and 28 Day Mortality	Mortality Rate - the number of deaths within 14 and 28 days from randomization	14-28 days from randomization
Conversion of COVID Household Members in CPAP vs Control	The number of household members converting from being COVID negative to COVID positive in the CPAP arm vs the control arm within 14 days from randomization	14 days from randomization
Change in Clinical COPD Questionnaire (CCQ)	Mean Change in CCQ - 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. Patients were monitored for 72 hours continuously, and then daily for a total of 14 days. The time frame is a change between the baseline COPD score at the time of enrollment and the last COPD score recorded within the following 14 days. The CCQ is a 10-item instrument questionnaire, with each question scored on a scale of 0 to 6. Thus, the full scale is 0 to 60, with higher score indicating lower health status. A negative value indicates that their score improved. A decrease in CCQ indicates improvement, Last Observation Carried Forward (LOCF) applied.	baseline and 14 days from randomization
Number of Patients Electing to Continue CPAP for Greater Than 72 Hours	Number of the patients in the CPAP arm elect to continue using the CPAP after the initial 72 hour period.	7 days from randomization
Number of Participants With Improvement in Oxygen Saturation	The number of participants with improvement in oxygen saturation within 14 days of randomization.	14 days from randomization
Number of Participants With Hospital Admission or ED	Number of participants with hospital admission or ED within 14 days of randomization	14 days from randomization

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Philips Healthcare; Itamar Medical LTD; Community Surgical Supply of Toms River, Inc
• Investigators: Principal Investigator: Neomi Shah, MD, MPH, MS, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2020
• Primary Completion (Actual): February 18, 2021
• Study Completion (Actual): July 7, 2021

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; Coronavirus; COVID-19; Non-invasive ventilation; Positive airway pressure; Hospital admission
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: GCO 20-0900

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No