COVID-19PAP-COVIDNCT04390191
Early CPAP in COVID-19 Confirmed or Suspected Patients
A study testing Continuous Positive Airway Pressure in people with COVID-19 and COVID, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, COVID, Coronavirus
- What is being tested?
- Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2020to 7 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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))
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, COVID, Coronavirus
- Being tested
- Continuous Positive Airway Pressure
- Keywords
- Continuous Positive Airway Pressure, COVID-19, Coronavirus, Positive airway pressure, Hospital admission, Non-invasive ventilation
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
Also called CPAP
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).
| Study group | Role | What they receive |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP) | Experimental | Patients will be given CPAP at fixed pressure of 8-10 cm water pressure for 72 hours continuously Receives: Device: Continuous Positive Airway Pressure |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (8)
Number of Participants Admitted to the ICU
Number of Participant with an admission to the intensive care unit within 14 days from randomization
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 14 days from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start7 May 2020
- Primary completion18 Feb 2021
- Study completion7 Jul 2021
Why it stopped: Declining cases of COVID in New York due to vaccinations and new treatments for outpatient management
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Itamar-Medical, Israel, Community Surgical Supply of Toms River, Inc, Philips Healthcare
- Responsible party
- Principal investigator, Neomi A Shah, Icahn School of Medicine at Mount Sinai
- Investigators
- Neomi Shah, MD, MPH, MS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390191
- Sponsor's protocol ID
- GCO 20-0900
- Acronym
- PAP-COVID
- Status last verified
- Sep 2022
- First submitted
- 12 May 2020
- Last updated
- 28 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Continuous Positive Airway Pressure (CPAP) in COVID-19 Confirmed or Suspected Patients
- ClinicalTrials.gov ID
- NCT04390191
- Acronym / sponsor ID
- PAP-COVID / GCO 20-0900
- Conditions
- COVID-19, COVID, Coronavirus
- Keywords
- Continuous Positive Airway Pressure, COVID-19, Coronavirus, Positive airway pressure, Hospital admission, Non-invasive ventilation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Declining cases of COVID in New York due to vaccinations and new treatments for outpatient management
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Itamar-Medical, Israel, Community Surgical Supply of Toms River, Inc, Philips Healthcare
- Study start
- 7 May 2020 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Posted 28 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP) | Experimental | Device: Continuous Positive Airway PressurePatients will be given CPAP at fixed pressure of 8-10 cm water pressure for 72 hours continuously |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway PressureAlso: CPAPCPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc). | Device | Continuous Positive Airway Pressure (CPAP) |
Primary outcome
Number of Participants Who Met the Efficacy Endpoint
Time frame: 14 days
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.
8 secondary outcomes
Number of Participants Admitted to the ICU
Time frame: 14 days from randomization
Time to Intubation and Mechanical Ventilation
Time frame: 14 days from randomization
Number of Deaths at 14 Day and 28 Day Mortality
Time frame: 14-28 days from randomization
Conversion of COVID Household Members in CPAP vs Control
Time frame: 14 days from randomization
Change in Clinical COPD Questionnaire (CCQ)
Time frame: baseline and 14 days from randomization
Number of Patients Electing to Continue CPAP for Greater Than 72 Hours
Time frame: 7 days from randomization
Number of Participants With Improvement in Oxygen Saturation
Time frame: 14 days from randomization
Number of Participants With Hospital Admission or ED
Time frame: 14 days from randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neomi Shah, MD, MPH, MS principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure in people with COVID-19 and COVID, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Met the Efficacy Endpoint (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.