Early Continuous Positive Airway Pressure (CPAP) in COVID-19 Confirmed or Suspected Patients
Phase: NA
Conditions: COVID-19, COVID, Coronavirus
Sponsor: Icahn School of Medicine at Mount Sinai

Early Continuous Positive Airway Pressure (CPAP) in COVID-19 Confirmed or Suspected 
Patients
PI: Neomi A Shah, MD, MPH
NCT04390191
Document Date: 4-22-2021

EARLY CPAP IN COVID-19 
INFECTED OR SUSPECTED PATIENTS
(PAP-COVID STUDY)
MANUAL OF PROCEDURES
VERSION 2; APRIL 22, 2021
Effective Date: 5/19/2021
End Date: 5/17/2022

TABLE OF CONTENTS
1 - GENERAL STUDY INFORMATION ......................................................................................................................5
1.1 INTRODUCTION........................................................................................................................................................5
1.2 DESIGN AND OBJECTIVES ...........................................................................................................................................5
Study Design .........................................................................................................................................................5
Objectives .............................................................................................................................................................6
1.3 SAMPLE SIZE, TIMELINE, AND ENDPOINTS .....................................................................................................................7
Sample size ...........................................................................................................................................................7
Timeline ................................................................................................................................................................7
Endpoints ..............................................................................................................................................................7
1.4 STUDY PHASES.........................................................................................................................................................8
Screening Phase....................................................................................................................................................8
Enrollment Phase..................................................................................................................................................8
Close-Out Phase....................................................................................................................................................8
1.5 PROTOCOL AMENDMENTS .........................................................................................................................................8
2 –  STUDY ORGANIZATION.................................................................................................................................10
2.1 PROJECT MANAGEMENT..........................................................................................................................................10
Study Personnel ..................................................................................................................................................10
Committees.........................................................................................................................................................10
2.2 MEETING SCHEDULES..............................................................................................................................................11
2.3 CLINICAL SITES.......................................................................................................................................................12
3 – STUDY OVERSIGHT........................................................................................................................................13
3.1 DATA MONITORING COMMITTEE (DMC) ...................................................................................................................13
Description..........................................................................................................................................................13
Reports................................................................................................................................................................13
Additional Information .......................................................................................................................................13
3.2 INSTITUTIONAL REVIEW BOARD.................................................................................................................................13
4 – SCREENING AND RECRUITMENT....................................................................................................................14
4.1 SCREENING AND RECRUITMENT OVERVIEW .................................................................................................................14
4.2 RECRUITMENT SOURCES ..........................................................................................................................................14
4.3 SCREENING PROCEDURES.........................................................................................................................................14
4.4 RECRUITMENT AND RETENTION OVERSIGHT.................................................................................................................17
Recruitment Tracking..........................................................................................................................................17
5 – PARTICIPANT POPULATION AND ELIGIBILITY.................................................................................................18
5.1 DESCRIPTION OF POPULATION ..................................................................................................................................18
5.2 ELIGIBILITY CRITERIA ...............................................................................................................................................18
Inclusion Criteria.................................................................................................................................................18
Exclusion Criteria ................................................................................................................................................18
6 – INFORMED CONSENT ....................................................................................................................................18
6.1 INFORMED CONSENT OVERVIEW ...............................................................................................................................18
Informed Consent Administration.......................................................................................................................19
HIPAA Authorization Form..................................................................................................................................20
Medical Information ...........................................................................................................................................20
6.2 CONFIDENTIALITY ...................................................................................................................................................20
Effective Date: 5/19/2021
End Date: 5/17/2022

6.3 ASSIGNMENT OF ID CODES ......................................................................................................................................20
7 –  STUDY PROCEDURES ....................................................................................................................................21
7.1 VISIT SCHEDULE .....................................................................................................................................................21
7.2 SCREENING VISITS ..................................................................................................................................................22
Preliminary Screening .........................................................................................................................................22
Screening Visit.....................................................................................................................................................22
7.3 VISIT 1.................................................................................................................................................................22
7.4 VISIT 2 (EQUIPMENT SET UP CALL)............................................................................................................................23
7.5 6-12 HOUR CHECKINS (UP UNTIL 72 HOURS) ..............................................................................................................23
7.6 DAILY CHECKINS (DAYS 4-7) ....................................................................................................................................23
7.7 DAILY CHECKINS (DAYS 8-14, 28).............................................................................................................................23
8 – WITHDRAWLS AND DROP-OUTS....................................................................................................................24
8.1 REFUSAL OF PARTICIPATION .....................................................................................................................................24
8.2 WITHDRAWALS......................................................................................................................................................24
Reasons for Withdrawal .....................................................................................................................................24
Procedures for Withdrawal.................................................................................................................................24
8.3 DROP-OUTS..........................................................................................................................................................25
Procedures for Drop-Outs ...................................................................................................................................25
8.4 VISIT WINDOWS AND MISSED VISITS .........................................................................................................................25
Visit Windows .....................................................................................................................................................25
Minimizing Missed Visits.....................................................................................................................................25
9 – RANDOMIZATION .........................................................................................................................................26
9.1 ELIGIBILITY FOR RANDOMIZATION..............................................................................................................................26
9.2 RANDOMIZATION PROCEDURES.................................................................................................................................26
Electronic Randomization ...................................................................................................................................26
10 – PROTOCOL DEVIATIONS AND ADVERSE EVENTS ..........................................................................................27
10.1 PROTOCOL DEVIATIONS.........................................................................................................................................27
Reporting Protocol Deviations ............................................................................................................................27
10.2 ADVERSE EVENTS AND UNANTICIPATED PROBLEMS.....................................................................................................27
Adverse Events....................................................................................................................................................27
Clinical Endpoints................................................................................................................................................27
10.5 DISCONTINUATION ...............................................................................................................................................28
Discontinuation – Treatment Stop/Discontinuation ...........................................................................................28
Urgent Medical Referral .....................................................................................................................................28
10.6 SURVEILLANCE .....................................................................................................................................................29
10.7 REPORTING ADVERSE EVENTS.................................................................................................................................29
How to Report an Adverse Event ........................................................................................................................29
10.8 FOLLOW-UP OF ADVERSE EVENTS ...........................................................................................................................29
During the Study .................................................................................................................................................30
11 – DATA MANAGEMENT..................................................................................................................................31
11.1 REDCAP.............................................................................................................................................................31
11.2 ONCORE ............................................................................................................................................................31
11.3 RIPPLE................................................................................................................................................................31
11.4 ENCOREEVERYWHERE ...........................................................................................................................................31
11.5 CLOUDPAT..........................................................................................................................................................31
Effective Date: 5/19/2021
End Date: 5/17/2022

12 – QUALITY ASSURANCE..................................................................................................................................32
12.1 QUALITY ASSURANCE PROCEDURES AND RESPONSIBILITIES...........................................................................................32
Coordinator Training...........................................................................................................................................32
12.2 DATA INTEGRITY ..................................................................................................................................................32
Inspections And Audits........................................................................................................................................32
Database and Systems Management.................................................................................................................32
Data Recovery.....................................................................................................................................................32
13 – REGULATORY COMPLIANCE.........................................................................................................................33
13.1 RECORD KEEPING AND SOURCE DOCUMENTS.............................................................................................................33
Record Retention ................................................................................................................................................33
13.2 INSTITUTIONAL REVIEW BOARD...............................................................................................................................33
13.3 CONTINUING REVIEWS ..........................................................................................................................................33
APPENDICES .......................................................................................................................................................34
FORMS ...............................................................................................................................................................35
SCREENING FORM........................................................................................................................................................35
ER ADMISSION DATA FORM...........................................................................................................................................37
VISITS FIGURE.....................................................................................................................................................39
VISITS FIGURE.....................................................................................................................................................40
Effective Date: 5/19/2021
End Date: 5/17/2022

1 - GENERAL STUDY INFORMATION
1.1 INTRODUCTION
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 only to decompensate later at home. Some patients die at home and others are returning to the 
Emergency Room with advanced 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. We therefore propose a prospective, single-center, parallel group, open-label, 
randomized clinical trial to assess the efficacy of 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. CPAP delivers positive pressure ventilation through a non-
invasive facemask and can therefore be used at home. There is limited evidence on the use of CPAP for 
viral pneumonia resulting in acute respiratory distress syndrome (ARDS), as it offers no clear advantage 
over mechanical ventilation. However, in the last two decades, two viral pandemics (SARS 2003 and 
H1N1 2009) have triggered investigation into the use of CPAP due to severe shortage of mechanical 
ventilators. The success rate of CPAP was as high as 84% in H1N1 infected hospitalized individuals with 
lower severity of illness. Further, CPAP use in COVID-infected patients with respiratory abnormalities 
has shown promise in other countries such as England, China and Italy.
1.2 DESIGN AND OBJECTIVES
STUDY DESIGN
This is a prospective, single-center, parallel group, open-label, randomized clinical trial, where 
we 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. We propose 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 the need for hospitalization or death in 
COVID-19 suspected or confirmed patients. We will include adult patients (age>18), 
oversampling when possible for obese patients who live alone or have more than one bedroom at 
home, with serologically confirmed or under investigation for acute 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 (see inclusion and exclusion criteria for 
more information). Participants in both arms will be shipped a pulse oximeter to monitor oxygen 
Effective Date: 5/19/2021
End Date: 5/17/2022

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 of 8 cm in women and 10cm in men and 
obese men and women will start be set at 10cm. of water pressure for 72 hours continuously 
(except for daily activities such as eating, grooming etc). We will adjust pressures in the range of 
8-10cm depending on patient's comfort and related assessments in follow up period. However, the
range of the pressure will remain constant throughout the study. 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 (information on this presented below). We hypothesize that early CPAP in
COVID infected patients who have respiratory abnormalities will decrease the risk of subsequent
hospitalization or death in 14 days from randomization.
OBJECTIVES
Aim 1: Given the expected shortage of ventilators to treat COVID-19 suspected or confirmed 
individuals with severe acute respiratory distress syndrome (SARS)/ARDS, we propose a 
prospective, single-center, parallel group, open label, randomized clinical trial of CPAP (n=100) 
vs. control (n=100) in COVID-19 suspected or confirmed patients with abnormal chest x-ray or 
respiratory symptoms. The overarching aim of this proposal is to determine if early use of CPAP 
at home reduces the need for hospitalization admission or death in COVID-19 suspected or 
confirmed patients. We will include adult patients (age>18), oversampling when possible for 
obese patients who live alone or have more than one bedroom at home, with serologically 
confirmed or under investigation for acute 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, i.e. being sent home. Patients with 
preexisting pulmonary diseases such as advanced COPD, advanced parenchymal lung disease, 
history of pneumothorax etc. will be excluded (see inclusion and exclusion criteria for more 
information). 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, patients in the 
treatment arm (n=100) will be randomized to receive CPAP at fixed pressure: 8 cm water 
pressure in women and 10cm water pressure in men. All obese patients (BMI>=30) will be 
treated with a fixed pressure of 10cm of water pressure (both men and women). The CPAP 
pressure will be adjusted based on patient's comfort but will not deviate from the range of 8-10cm 
noted above. The treatment will be prescribed for 72 hours continuously (except for daily 
activities such as eating, grooming etc). 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. 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. We hypothesize 
that initiation of early CPAP in COVID infected patients with respiratory abnormalities will 
decrease the risk of subsequent hospitalization or death in 14 days from randomization. Patients 
will be followed for 28 days and as a secondary endpoint we will assess 28 day mortality as well 
as to assess for late impact of CPAP.
Effective Date: 5/19/2021
End Date: 5/17/2022

Aim 2: Younger Americans with COVID-19 infection have a higher rate of hospitalization and 
need for mechanical ventilation compared to younger citizens of other countries. One potential 
explanation is high obesity prevalence. Obstructive sleep apnea is present in over 50% of obese 
individuals and obesity further compromises lung compliance and ability to handle increased 
ventilatory demand seen in COVID-19 patients with related lung injury. Further, COVID infected 
individuals with OSA may be at higher risk for progression from mild pneumonia to ARDS 
however this remains to be determined. Therefore in Aim 2, we will determine if obstructive 
sleep apnea (OSA) is associated with increased hospitalizations and mechanical ventilation in 
COVID-19 suspected or confirmed patients. This will be achieved primarily through our control 
group (not receiving PAP therapy but will receive home sleep apnea testing). This is of vital 
importance as the primary treatment of OSA is CPAP and there are more than 8 million CPAP 
users in the United States. This treatment can therefore be leveraged to treat mild respiratory 
distress in COVID infected OSA patients in the face of a crisis with hospital and ventilator 
shortage. We hypothesize that obese patients with COVID-19 infection are more likely to be 
hospitalized or receive mechanical ventilation compared to non-obese individuals with COVID-
19 infection. In exploratory analysis, we will also assess if OSA is an independent risk factor for 
hospital admission or death in our control group. We expect obesity and OSA to be correlated and 
will determine the independent impact of each of these on our primary endpoint.
Aim 3: To leverage EHR to determine a risk score to predict readmission to the Emergency room 
in COVID-infected or suspected patients. This aim will be done simultaneously while Aims 1 and 
2 are ongoing and will be implemented in real-time to identify high-risk patients.
1.3 SAMPLE SIZE, TIMELINE, AND ENDPOINTS
SAMPLE SIZE
We anticipate that approximately 200 patients will participate in this study. Randomized clinical 
trial of CPAP (n=100) vs. control (n=100) in COVID-19 suspected or confirmed patients with 
abnormal chest x-ray or respiratory symptoms. 
TIMELINE
We anticipate that accrual will occur over a 1-3 month period, beginning as soon as IRB approval 
is obtained. The study will last until we have 100 participants in each group, and each group 
completes all phases of the trial.
ENDPOINTS
Primary endpoint:
The primary efficacy endpoint is a non-weighted composite endpoint 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 endpoints:
•
Time to ICU admission within 14 days of randomization
Effective Date: 5/19/2021
End Date: 5/17/2022

•
Time to intubation and mechanical ventilation within 14 days of randomization
•
Time to death within 14 and 28 days of randomization
-
Degree of improvement in oxygen saturation within 14 days of randomization
-
Improvement in respiratory symptoms of cough, shortness of breath, etc via respiratory
symptom questionnaire within 14 days of randomization
-
Adverse events and conversion rates of COVID family members in CPAP vs control within
14 days of randomization
-
Percent of patients electing to continue CPAP for greater than 72 hours
-
Time to hospital admission or ED visit within 14 days of randomization
1.4 STUDY PHASES
SCREENING PHASE
Eligible participants will be identified by:
1)
Precision Recovery Program. This program is a Sinai-wide initiative which is remotely
monitoring patients who are sent home from the emergency room. This is similar to our
protocol and therefore working with the precision recovery program will be a synergistic
effort.  We will exclusively recruit from their pool of patients when possible, as the
precision recovery program will hand out our fliers to their participants, and therefore will
ensure that the patient does not get a cold call from us.
2)
Emergency room staff members. Members of the research team (primarily Emergency
Room department, in these following two locations: main ED, and surge space (Martha
Stewart)) will identify and provide flyers to the patients as discussed above.
3)
Via EPIC screening. Subjects will also be identified using the EPIC database of COVID
confirmed/suspected patients lists to see if patients meet our inclusion criteria.
At the time of introducing the study to the patient, the inclusion/exclusion criteria will be 
reviewed by the study team member.
ENROLLMENT PHASE
For all participants, this phase occurs from the time of consent through on average a period of 
about 28 days. All participants will be followed until their 28 day participation. Procedures are 
outlined in the “Study Procedures” section. The enrollment phase may continue past these points 
for participants requiring ongoing monitoring of an AE.
CLOSE-OUT PHASE
The closeout phase includes confirming that all queries are addressed, the dataset is finalized, 
locked and analyzed, all documentation is appropriately stored, and the study is closed with the 
Institutional Review Board (IRB).
1.5 PROTOCOL AMENDMENTS
The objectives of the PAP-COVID study are most likely to be achieved if the protocol does not require 
alteration. Any changes in the protocol would result in some degree of heterogeneity of the data, which 
may complicate the analyses and may compromise the scientific integrity of the study. However, 
Effective Date: 5/19/2021
End Date: 5/17/2022

occasions may arise in which protocol changes are necessary. Therefore, changes in the protocol will be 
considered only if they are required to ensure safety or will significantly enhance the scientific validity or 
feasibility of the study. Any member of the PAP-COVID study team may request a change to any portion 
of the study protocol. The staff member wishing to change the protocol should present the proposed 
changes(s) in writing to the PI, who will then contact other relevant personnel. The Executive Committee 
will then jointly decide on the appropriate mechanism (letter, conference call, or meeting) to handle the 
proposal depending on the implications of the proposed change. Proposed changes will be presented to all 
study members via conference call or formal meeting to allow all members to benefit from the scientific 
debate generated in these discussions. Proposed changes can be implemented only after the PI and 
relevant personnel reach a majority vote. Once a proposed change has been approved, the Research 
Manager will coordinate all activities required to implement the change via the issuance of a protocol 
amendment document and revised protocol. Substantive changes to the protocol and ancillary proposals 
must be submitted to the Data Monitoring Committee (DMC) for review and approval before 
implementation can occur.
Effective Date: 5/19/2021
End Date: 5/17/2022

2 –  STUDY ORGANIZATION
2.1 PROJECT MANAGEMENT
STUDY PERSONNEL

Neomi Shah: PI; all study activities

Samira Khan: Project Manager; management of day to day operations, all enrollment
activities, AE log

Indu Ayappa: Co-Investigator; PI backup, all study activities

Priti Balchandani: Co-Investigator

Kevin Munjal: Co-Investigator, ED; ED communication & liaison

Kusum Matthews: Co-Investigator, Critical Care; COVID symptoms liaison

Omar Burschtin: Co-Investigator, Sleep; interpreting physician for sleep studies

David Rapoport: Co-Investigator, Sleep; CPAP oversight

Mayte Suarez Farinas: Lead Biostatistician; data analysis RedCAP management and
oversight

Helena Chang: Statistician: Data Analysis; RedCAP management and oversight

Andrew Varga: Sleep Expert

Marina Caskey: Infectious Disease Expert

Zachary Roberts: Sleep Technician; equipment set up, CPAP adherence monitoring

Bresne Castillo: Sleep Technician; equipment set up, CPAP adherence monitoring

Sanjana Inala: Research Coordinator; screening, recruitment, CRFs

Michelle Rolak: Research Coordinator; screening, recruitment, CRFs
COMMITTEES
•
Executive Committee: Neomi Shah, Indu Ayappa, Samira Khan
•
Research Operations: Neomi Shah, Indu Ayappa, Samira Khan
•
Data Management: Neomi Shah, Indu Ayappa,Mayte Suarez Farinas, Helena Chang
•
Clinical Oversight: Neomi Shah, Indu Ayappa, Kevin Munjal, Kusum Matthews, Omar
Burschtin, David Rapoport
•
Data Monitoring Committee: Neomi Shah, Indu Ayappa, Sunjata Patil, Marina Caskey,
Andrew Varga
Effective Date: 5/19/2021
End Date: 5/17/2022

2.2 MEETING SCHEDULES
Each of the major committees will meet on a regular basis: Usual meeting (by phone or video conference) 
intervals are as follows, but may vary at the discretion of the Chair, depending on the study needs: 
•
Executive Committee: Every two weeks by conference/Zoom call
•
Research Operations: Every week by conference/Zoom call
•
Data Management: Monthly or more frequent intervals, as needed, by conference/Zoom call
•
Clinical Oversight: Monthly or more frequent intervals, as needed, by conference/Zoom call
•
Data Monitoring Committee: The DMC will meet prior to trial initiation to discuss the Charter,
review and approve the study protocol prior to study initiation, review any other relevant
documents, and make recommendations to the sponsor and study team regarding possible
modifications. Future meetings will review the accumulating data on safety and, study quality and
will be scheduled approximately three times during the course of the trial (after 25%, 50% and
100% of patients reach the primary endpoint at 14 days post-randomization). Meetings will be
conducted via zoom. A DMC meeting will require a quorum.
To aid communication, a study OneDrive will be developed which will include areas for posting study 
documents, interactive study progress reports, quality control reports, and a publications hub.
Effective Date: 5/19/2021
End Date: 5/17/2022

2.3 CLINICAL SITES
Subjects are at-home patients discharged or denied entry to the ER at any Mount Sinai hospital. All study 
contact (ie. recruitment, consent, explanation of study procedures) will occur remotely via telephone and 
video calls. Study devices will be shipped to the patients' home. The patient will then use the devices in 
their own homes.
Effective Date: 5/19/2021
End Date: 5/17/2022

3 – STUDY OVERSIGHT
3.1 DATA MONITORING COMMITTEE (DMC)
DESCRIPTION
This Charter is for the Data Monitoring Committee (DMC) for the Early Continuous Positive Airway 
Pressure (CPAP) in COVID Confirmed or Suspected Patients study (PAP-COVID Study). 
This Charter defines the primary responsibilities of the DMC, it’s relationship with other trial 
components, its membership, and the purpose and timing of its meetings. The Charter also provides the 
procedures for minimizing conflicts of interest and ensuring confidentiality of emerging data and 
deliberations of the DMC, as well as statistical monitoring guidelines to be considered by the DMC, if 
any. It will also address the content of the Open and Closed Reports that will be provided to the DMC.
REPORTS
For each DMC meeting, interim safety reports including reports of all mortalities, household COVID 
conversions, and adverse events will be prepared by the trial statistical team. In addition to the pre-
scheduled meetings, the DMC Chair will receive and review reports of all mortalities, unexpected serious 
adverse events, and COVID conversions within 72 hours of the Investigator becoming aware of the event 
as well.
ADDITIONAL INFORMATION
More information regarding DMC membership, responsibilities, and operations can be found in the DMC 
Charter (separate document).
3.2 INSTITUTIONAL REVIEW BOARD
This study is to be conducted according to U.S. and international standards of good clinical practice, 
applicable government regulations and institutional research policies and procedures. The final study 
protocol and any amendments will be submitted to the IRB and Mount Sinai COVID-19 Research 
Protocol Committee. The decision of the IRB concerning the conduct of the study will be made in writing 
to the PI and a copy of this decision will be provided to the sponsor before commencement of this study.
Effective Date: 5/19/2021
End Date: 5/17/2022

4 – SCREENING AND RECRUITMENT
4.1 SCREENING AND RECRUITMENT OVERVIEW
Overall recruitment should focus on patients with known or suspected COVID-19 who are experiencing 
symptoms, and have been discharged from or denied admission to the ED.
4.2 RECRUITMENT SOURCES
Eligible participants will be identified by:
4)
Precision Recovery Program. This program is a Sinai-wide initiative which is remotely
monitoring patients who are sent home from the emergency room. This is similar to our
protocol and therefore working with the precision recovery program will be a synergistic
effort.  We will exclusively recruit from their pool of patients when possible, as the
precision recovery program will hand out our fliers to their participants, and therefore will
ensure that the patient does not get a cold call from us.
5)
Emergency room staff members. Members of the research team (primarily Emergency
Room department, in these following two locations: main ED, and surge space (Martha
Stewart)) will identify and provide flyers to the patients as discussed above.
6)
Via EPIC screening. Subjects will also be identified using the EPIC database of COVID
confirmed/suspected patients lists to see if patients meet our inclusion criteria.
4.3 SCREENING PROCEDURES
EPIC screening procedures are as follows:
1)
Click on Epic logo dropdown top left corner
2)
Reports  My Reports
Effective Date: 5/19/2021
End Date: 5/17/2022

3)
Click Library left hand side
4)
Search “COVID”
5)
“Star” COVID-19 Confirmed Prior thru Current Discharges by sites
a.
This shows you positive discharge patients
Effective Date: 5/19/2021
End Date: 5/17/2022

6)
“Star” COVID-19 Confirmed Prior thru Current
a.
This shows all COVID from MSH
7)
“Run” the report
8)
Open patient chart, go to Notes, and read ED Provider Notes (symptoms)
a.
Check for inclusion/exclusion criteria in chart
i.
(ALL EXCLUDED PATIENTS ADD TO RIPPLE, add note for exclusion)
b.
Call patient to see if interested
Once contacted patient,
1)
If interested, input in OnCore and begin study
2)
If not interested, add to Ripple and add a note saying not interested
Dashboard (MSH COVID Statistics)
EPIC  Reports  My dashboards
1)
My dashboards
2)
Search: “MSH COVID-19 Monitoring”
Effective Date: 5/19/2021
End Date: 5/17/2022

3)
Star “MSH COVID-19 Monitoring Dashboard”
4)
Run report
5)
Scroll down to bottom, click “MSH ED SURGE”
6)
Double click to see patients
4.4 RECRUITMENT AND RETENTION OVERSIGHT
RECRUITMENT TRACKING
Tracking will occur through online software: Oncore and Ripple. Patients who enroll will be 
tracked in Oncore. Patients who decline to enroll, or are ineligible will be recorded in Ripple to 
prevent double calling.
Effective Date: 5/19/2021
End Date: 5/17/2022

5 – PARTICIPANT POPULATION AND ELIGIBILITY
5.1 DESCRIPTION OF POPULATION
This study will involve participation of adults with confirmed or suspected COVID-19 and abnormal 
chest X-ray or clinical symptoms. Adults ≥ 18 years of age, of both genders and all racial and ethnic 
groups will be eligible for participation. Inclusion and exclusion criteria refer to the participant only.
5.2 ELIGIBILITY CRITERIA
Eligibility criteria are listed on the Eligibility [ELIG] CRF, and below.
INCLUSION CRITERIA
1.
Adults > 18 years old
2.
Patients living alone or with more than one room at home
3.
COVID-19 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)
6 – INFORMED CONSENT
6.1 INFORMED CONSENT OVERVIEW
Each coordinator is responsible for ensuring that informed consent is obtained from each participant 
according to the guidelines of the central IRB, and all applicable local hospital and regulatory 
requirements. The consent procedure will include ongoing review of vital status and hospitalizations 
Effective Date: 5/19/2021
End Date: 5/17/2022

through regular review of the EMRs from the local medical center(s), as well as the request of records 
from outside medical institutions when hospitalizations are reported at those institutions. Specifically, the 
following must be accomplished during the informed consent process:
The participant must be informed that participation in the study is voluntary, and that refusal to participate 
will involve no penalty or loss of benefits; 
•
The participant must be informed that the study involves research;
•
The participant must be informed of any alternative procedures;
•
The participant must be informed of any reasonable foreseeable risks;
•
The participant must be informed of any benefits of participating in the research;
•
An outline of safeguards to protect confidentiality must be included, as well as an indication of
which parties are allowed to review the record;
•
The participant must be informed of their right to withdraw without penalty. This discussion
should be balanced with a discussion of the effect/s withdrawals have on the study, and the
responsibility that the participant has, within limits, to continue in the study if they decide to
enroll;
•
The participant must be informed of their right to have questions answered at any time, and
should be given adequate time to consider the study obligations and discuss the study with family
members or other prior to consenting;
INFORMED CONSENT ADMINISTRATION
After patients have verbally agreed to participate in the study, they will complete an e-consent.
The research staff will walk the patient through the e-consent and explain the study, risks and
benefits in detail to the participant. The Mount Sinai approved Phone Consent process will be
utilized, including having a witness present or having the patient send back signed documents in
the case a witness is not able to be present.
Once deemed eligible, the study coordinator will provide the participant with a copy of the ICF.
The study coordinator will explain in lay persons’ terms the nature of all procedures. After the
participant has had a chance to ask questions, the ICFs must be signed and dated.
Ample time should be given to allow the participant to read the ICFs, process the information,
and ask questions. If the participant wishes to take the ICFs home before reaching a decision, they
may do so. At the subsequent visit, the PI and/or other investigator should answer any questions
raised by the participant. The participant should be made aware of their responsibilities
throughout the screening process, during the baseline visit, after the randomization assignment,
and throughout the study period. The importance of continued follow-up should be stressed and
balanced with a discussion of the effect of withdrawal on the study.
The ICFs must be signed and personally dated by the participant (if a witness is not present), and
by the principal investigator or designated staff member obtaining consent. The staff member
obtaining consent and signing the ICF does not need to be a physician. The participant should not
be asked to sign the ICF if they have any doubts about enrolling, or if the study staff member
believes that the participant does not understand what participation would involve. Under no
circumstance is any study information to be collected or study procedures performed other than
those described for screening in Section 4.3, before the participant has signed the ICF. The study
coordinator will maintain the original, signed ICFs in the participant’s Source Document Binder
with other study documentation, and provide a copy of the signed ICFs to the participant who
Effective Date: 5/19/2021
End Date: 5/17/2022

should be urged to retain the document for future reference. To ensure confidentiality, the study 
coordinator will not send copies of the ICFs signed by the participant to the DCC or other core 
groups.
HIPAA AUTHORIZATION FORM
Medical records will be screened in order to identify eligible patients. We will only be contacting 
patients if they meet the inclusion criteria, thus would be unable to obtain HIPAA authorization 
from them prior to viewing PHI. We are requesting a waiver for recruitment purposes only and 
will obtain full HIPAA Authorization from subjects who sign the consent form.
MEDICAL INFORMATION
All patients will be within the Mount Sinai health system, and their medical records will be 
screened in order to identify eligible patients. Waivers and signing for full HIPAA authorization 
will be obtained.
6.2 CONFIDENTIALITY
Confidentiality is strictly maintained throughout the study. All study personnel have been trained about 
the importance of confidentiality and steps toward guarding it have been incorporated. In order to protect 
the privacy interests of subjects, we will ensure that all data will be entered into a secure and password 
protected electronic database (REDCap, OnCore, Ripple). Only study-related personnel will have access 
to the data and subject identifiers. All data will be collected electronically. When coding data, subject 
names will be stored separately from all other data, and ID codes are substituted for subject names.
6.3 ASSIGNMENT OF ID CODES 
Each participant will be assigned an ID code upon consent. This code will be entered into Redcap and 
will be used for all communication purposes. Only the PI, Research manager, and research coordinator 
will be able to link ID codes to each participant. 
Effective Date: 5/19/2021
End Date: 5/17/2022

7 –  STUDY PROCEDURES
7.1 VISIT SCHEDULE
Study Procedures: 
1)
Patients will be screened as described earlier
2)
Eligible patients will be provided a flyer by ED provider when possible but may also be contacted
by telephone once they have been discharged. (Of note: we are being approached by patients who
are discharged from the hospital with COVID pneumonia who continue to experience shortness
of breath and are requesting a CPAP without having prior knowledge of this study).
3)
Research will be introduced to the patient, and if they agree to participate, a telephone consent
will be conducted (according to IRB requirements including witness). Once patients have
enrolled in the study, their PMD will also be notified of their participation. The patient will also
be added to the study on EPIC, so that all treating physicians are aware of the patient's
participation in our study.
4)
Once patients have enrolled in the study, a pulse oximeter and a disposable WatchPAT One
device will be mailed to the patients (within 24-48 hours of discharge). Orders placed before noon
will be delivered the same day by a local durable medical equipment company we are working
with. Orders placed past noon, CPAP delivery will be done the subsequent day or upto 48 hours if
outside the New York area. Patients who are randomized to the treatment arm will receive a
CPAP machine and three full-face masks in addition to the above noted equipment.
5)
Patient will then be instructed via facetime or other video platform on CPAP setup and use, face
mask fitting (those randomized to CPAP), and use of the WatchPAT One and pulse oximeter (for
both CPAP and control arm). All participants will wear the WatchPAT one for one night whereas
the oximeter will stay on continuously and the patient will report the saturation to us via follow
up survey.
6)
Patients randomized to receive CPAP will be asked to stay in isolation throughout the duration of
the study i.e. 72 hours. They will be required to stay in a different room with the door shut and
windows open (weather permitting). We will also ask the patient to stop using CPAP during
meals or other daily activities. Subjects not on CPAP machine will also be instructed to sleep in a
room with windows open (weather permitting).
7)
Patients will use the CPAP machine as instructed for 72 hours.
8)
All patients will be contacted every 6-12 hours to complete follow up assessments. These follow
ups will be done via a phone call. If the timing of these follow ups fall between 10pm-6am, the
follow up will be deferred until after 6am. After 72 hours, all patients will then be contacted daily
until day 14 from randomization. After day 14, research staff will continue to monitor the medical
charts for any visits to the hospital. One last contact will be made on day 28.
9)
After 72 hours, patients will be asked to discontinue using the CPAP and pulse oximeter. If
patients wish to continue to use the CPAP, they may do so for up to 7 days from time of
randomization.
10) The research staff will continue to call all patients daily (after the 72 hour mark) to assess
symptoms.
11) The patients can also choose to monitor their oxygen saturation beyond the 72 hours of treatment.
12) CPAP download is available continuously however we will download data on usage, pressure,
leak daily and make adjustments to the mask or CPAP pressure as needed for patient comfort. For
patients experiencing significant trouble tolerating high pressure, we will decrease CPAP from 8-
10 cm to a fixed CPAP of 5 cm for 2-4 hours after which we will raise it back to 8-10cm for the
Effective Date: 5/19/2021
End Date: 5/17/2022

duration of the study. If the patient is not able to tolerate the pressure again, we will reduce it 
back to 5cm of water pressure for several hours before increasing the pressure. This will be 
continued until the patient withdraws or 72 hours are completed, whichever occurs first. 
13) Patients will be asked to track their own oxygen saturation using the provided pulse oximeter and
report it when we contact them for the 6-12 hour follow up calls/surveys.
14) The sleep apnea test will provide continuous oxygen and breathing data for a period of 12 hours
during the 72 hours and will also provide information on oxygen saturation while the patient is
asleep.
The outline of the forms that correspond to the study visits can be found in the Appendix, Figure 1. All of 
these forms are subsequently included in the following appendicies.
7.2 SCREENING VISITS
PRELIMINARY SCREENING
A research coordinator will conduct preliminary screening prior to contacting patient. 
SCREENING VISIT
Upon reaching out to patient, the coordinator will confirm enrollment eligibility with the patient 
prior to consenting. 
7.3 VISIT 1
Visit 1 is performed by the coordinator. It consists of the following forms: 
•
Phone consent
•
Enrollment Eligibility Form
•
ER Admission Data Form
•
Demographics and Subject History Form
•
Participant Contact Form
•
Medications Form
•
CPAP and WatchPAT Assignment Form
•
PROMIS questionnaire Form
•
Randomization Form
•
Respiratory Questionnaire Form
1.
Once the Mount Sinai team has randomized patient, we will email
covid19cpap@communitysurgical.com with demographics and equipment ordered.
2.
Community surgical will call patient to confirm address and information, they will then initialize the
WatchPAT.
3.
The pin used will be the DOB in the following format: MMDD
4.
The pin will be written on the WatchPAT box as well
5.
Community surgical will then deliver the equipment box to the patient. Patient will receive
documents to sign via docusign.
Effective Date: 5/19/2021
End Date: 5/17/2022

6.
Once delivery has been made, community surgical will notify PI
7.
Community surgical will register patient on encoreanywhere – once patient has been registered it will
take approximately 24 hours before we are able to see the patient on our end
7.4 VISIT 2 (EQUIPMENT SET UP CALL)
Visit 2 is done by the sleep technicians. It consists of the following forms: 
•
CPAP Set Up Form
•
WatchPAT and POX Set Up Form
7.5 6-12 HOUR CHECKINS (UP UNTIL 72 HOURS)
The subsequent check-ins are done by the coordinator. They consist of the following forms: 
•
Follow-up Questionnaire
•
Respiratory Questionnaire Form
•
CPAP Adherence Form
•
CPAP Use Form
7.6 DAILY CHECKINS (DAYS 4-7)
After 72 hours, check-ins occur daily. For patients on CPAP, the forms to be filled out are:
•
Follow-up Questionnaire
•
Respiratory Questionnaire Form
•
CPAP Adherence Form
•
CPAP Use Form
For patients not on CPAP, the forms to be filled out are:
•
Follow-up Questionnaire
•
Respiratory Questionnaire Form
7.7 DAILY CHECKINS (DAYS 8-14, 28)
After 7 days, check-ins continue to occur daily. For patients on CPAP, the forms to be filled out are:
•
Respiratory Questionnaire Form
•
Interval Assessment Form
•
Investigator Statement Form (Day 28)
Effective Date: 5/19/2021
End Date: 5/17/2022

Effective Date: 5/19/2021
End Date: 5/17/2022

8 – WITHDRAWLS AND DROP-OUTS
8.1 REFUSAL OF PARTICIPATION
A record will be kept of all participants who are ineligible, or approached but are not interested in 
participation in the study prior to the signing the ICF. This is to prevent double calling patients. The MRN 
and reason for ineligibility/disinterest will be logged in Ripple. We will let the patients we call know their 
MRN will be stored in Ripple. This data will be deleted when the study is over. 
8.2 WITHDRAWALS
Participants whose participation in the study is terminated prematurely (before final participant completes 
their 28-day endpoint visit) at their own discretion or that of the investigator are considered withdrawals. 
The withdrawal request can be made during a phone contact. When possible, willing participants will 
have follow-up data collected, including electronic medical record data.
REASONS FOR WITHDRAWAL
Participants are free to withdraw from the study at any time. The various reasons for withdrawal 
may include: 
o
Experiencing an AE;
o
Dissatisfaction with treatment;
o
Significant concurrent illness;
o
Loss of interest in the study;
o
Relocation.
Participants may also be withdrawn from the study by the investigators, for protocol non-
compliance or other reasons at the discretion of the site PI. All withdrawals should be reported 
following the procedures below.
PROCEDURES FOR WITHDRAWAL
Once it has been established that a participant is going to be withdrawn from the study, the study 
coordinator should complete the End of Study CRF. If the participant has been randomized, the 
study coordinator should also complete the Treatment Stop CRF. 
Study Stop Resulting from Withdrawal 
Once withdrawal is established the study coordinator fills out the End of Study CRF by 
recording:
o
That the participant did not complete the study per protocol;
o
The last study visit the participant completed;
o
The date participation stopped (the day withdrawal was established); • The primary
reason cited for ceasing participation;
Effective Date: 5/19/2021
End Date: 5/17/2022

The End of Study CRF must be completed in Slice within 24 hours of withdrawal. This will allow 
the DCC to begin the data archival process.
8.3 DROP-OUTS
Participants who drop out will be distinguished from those who withdraw based on whether they actively 
withdraw versus passively dropped out by not responding to phone interviews.
PROCEDURES FOR DROP-OUTS
Participants who do not answer or respond to phone calls will be considered possible drop-outs. 
Following a missed visit, the study coordinator must:
o
Immediately place a call to the participant in an attempt to re-establish contact and leave
a voice message if possible detailing the importance of contacting study staff in order to
gather critical data, whether or not they intend to continue participation.
o
Query the Mount Sinai Expired list, frequently.
o
Continue to call twice a day for 7 days until you hear from patient. If patient misses 2-3
consecutive calls, check the emergency contact.
o
Once the participant has not responded and the emergency contact is unavailable, the PI
should be notified. The End of Study form may be filled out given the situation.
8.4 VISIT WINDOWS AND MISSED VISITS
VISIT WINDOWS
Check-ins should occur based on the “schedule” form.
MINIMIZING MISSED VISITS
To minimize the occurrence of missed appointments, the participant should be provided with 
the following when appropriate:
•
Visit Schedule of in-window visits generated and provided at the baseline visit;
•
Text reminders to patients to fill out forms
Effective Date: 5/19/2021
End Date: 5/17/2022

9 – RANDOMIZATION
9.1 ELIGIBILITY FOR RANDOMIZATION
Only participants who have successfully completed the entire screening process will be eligible for 
randomization. The following will be assessed to confirm eligibility:
•
The inclusion and exclusion criteria will be reviewed, checked, and verified by completing the
Screening and Eligibility CRF during the screening and baseline visit prior to randomization.
The PI and study coordinators will be the only people who has authorization to access the randomization 
database. The study coordinator must complete the Screening and Eligibility CRF in RedCAP to receive 
the computer-generated randomization code. The randomization code will not be assigned until all the 
questions have been answered and automatically crosschecked in the system with previously entered data 
to confirm eligibility. The randomization process is an administrative task that occurs after all the 
screening and baseline data have been collected and entered into RedCAP. The study coordinator may 
randomize the subject at the end of the baseline visit with the participant present or within 12 hours of the 
baseline visit.
9.2 RANDOMIZATION PROCEDURES
ELECTRONIC RANDOMIZATION
The PI and Research Manager will be responsible for randomization. Once patient has been 
deemed eligible and coordinator has entered in the appropriate documents, the PI will review with 
the research manager and sign off. An automatic electronic randomization process has been built 
in to the redcap database. 
Effective Date: 5/19/2021
End Date: 5/17/2022

10 – PROTOCOL DEVIATIONS AND ADVERSE EVENTS
10.1 PROTOCOL DEVIATIONS
Deviations are variances from the IRB  (and sponsor when one exists) approved 
protocol/protocol related materials that have not been pre-approved and 1) imposed no increase in 
risk to the participant and 2) did not result in a negative consequence and is not anticipated to 
result in a negative consequence in the future.
Violations are variances from the IRB (and sponsor when one exists) approved protocol/protocol 
related materials that have not been pre-approved and 1) imposed an increase in risk to the 
participant and/or 2) resulted in a negative consequence or is anticipated to result in a negative 
consequence in the future.
REPORTING PROTOCOL DEVIATIONS
All protocol deviations must be reported using the Protocol Deviations CRF. Note that a protocol 
deviation that is also an AE should be reported as an AE rather than a deviation.
Reasons for deviation:
o
Informed Consent not obtained/signed/dated
o
Incorrect version of Informed Consent obtained/signed/dated
o
Eligibility Criteria not met
o
Randomization not performed as required
o
Not all required testing/assessments completed
o
Follow-up visit/testing/assessments done outside of visit window
o
Follow-up visit not done/missed
o
SAE submitted to Sponsor and/or EC outside the required timeframe
o
Not all required testing/assessments completed and follow-up visit/testing/assessments
done outside of visit window
10.2 ADVERSE EVENTS AND UNANTICIPATED PROBLEMS
Ad adverse event is considered “unexpected” if it is not listed in the protocol, or Informed Consent Forms 
or is not listed at the specificity, severity or rate of occurrence that has been observed; or, is not consistent 
with the risk information described in the general investigational plan or elsewhere.
ADVERSE EVENTS
An AE is any unfavorable or unintended sign, symptom or disease occurring in a participant at 
any stage of the study, whether or not considered related to the study. 
CLINICAL ENDPOINTS
Any reported AEs that meet the following are also clinical endpoints and will be reported on the 
End of Study form. DMC Project Manager will review all AEs to determine if they also meet 
Effective Date: 5/19/2021
End Date: 5/17/2022

clinical endpoint criteria. If criteria are met, the DMC Project Manager will ensure all 
documentation need for endpoint review is received by the site study coordinator.
10.5 DISCONTINUATION
DISCONTINUATION – TREATMENT STOP/DISCONTINUATION
Participants may require additional/alternative therapies that may or may not be exclusionary 
criteria and are designed to minimize the potential risks to participant’s safety which can result in 
discontinuation of the study treatment. Discontinuation can be observed during either routine 
interim follow-up phone calls or visits, or as a result of study contact by the participant or the 
participant’s physician. If the participant is deemed a ‘discontinuation – treatment stop’, the 
Treatment Stop CRF must be completed, arrangements for the return of the concentrator must be 
made, and the participant should still be followed-up per protocol, despite no longer receiving the 
study intervention, if agreed. Discontinuation – treatment stop in PAP-COVID are defined as 
follows: 
• The participant’s physician has identified a change in signs or symptoms that in his/her
opinion are related to ongoing symptoms of COVID-19 and therefore warrant alternative
treatment, such as permanent supplemental oxygen
URGENT MEDICAL REFERRAL
Patients have 24/7 access to the Precision Monitoring Program doctors. These doctors include: 
o
Dr. Christopher Kellner (Dept. of Neurosurgery)
Anticipated Adverse Events (AAE)
Unanticipated Adverse Events (UAE)
o
Headaches
o
Fever
o
Chills
o
Loss of appetite
o
Nausea
o
Vomiting
o
Fatigue
o
Muscle or body aches
o
New loss of taste or smell
o
Sore throat
o
Congestion or runny nose
o
Diarrhea
o
Decrease in oxygen
saturation (that is not
associated with shortness
of breath or difficulty
breathing)
o
Oxygen saturation less
than 90 during the
monitoring period
o
Absolute reduction in
oxygen saturation of more
than 4% associated with
shortness of breath or
difficulty breathing
o
Persistent pain or pressure
in the chest
o
Any worsening of COVID
symptoms that lead to an
Emergency room visit,
hospital admission, ICU
admission, intubation, or
mechanical ventilation
o
Any Adverse effect
on the health or
safety caused by, or
associated with, the
CPAP or progression
of underlying COVID
that was not
previously identified
in the product
labeling, published
literature or study
protocol
o
Any event that
results in death
o
Conversion of
family members
to COVID
positive in the
CPAP group
Reporting
None
Redcap
None
Redcap, DSMB, IRB
Effective Date: 5/19/2021
End Date: 5/17/2022

o
Dr. Johanna Fifi (Dept. of Neurosurgery)
o
Dr. Mariam Zakhary (Dept. of Rehab and Human Performance)
o
Dr. Dayna McCarthy (Dept. of Rehab and Human Performance)
o
Dr. Eliana Cardozo (Dept. of Rehab and Human Performance)
o
Dr. Vincent Huang (Dept. of Rehab and Human Performance)
o
Dr. Kirk Lercher (Dept. of Rehab and Human Performance)
o
Dr. Gerardo Miranda-Comas (Dept. of Rehab and Human Performance)
o
Dr. Joseph Gladstone (Dept. of Orthopedics) tentative
10.6 SURVEILLANCE
At each contact with the participant, the investigator must seek information on AEs, clinical 
endpoints, and urgent medical referrals. Information on all events/problems should be recorded 
immediately. All events/problems occurring during the study period must be recorded and 
reported. The clinical course of each event should be followed until resolution, stabilization, or 
until it has been determined that the study treatment or participation is not the cause and the event 
is not a defined clinical endpoint. Monitoring events/problems is a constant task given to all study 
personnel, and should be accomplished using all available sources, including (but not limited to): 
o
Spontaneous reports by the participant;
o
Observations by key study personnel;
o
Reports to study staff by the participant or medical care providers;
o
Possible AE documented in records or progress notes.
In addition to receiving reports of potential AEs, the study coordinator should develop and 
implement a plan to monitor for AEs consistently and routinely through proactive measures such 
as: 
o
Review participant’s records for additional information;
o
Communicate with participant’s medical providers if necessary.
In addition to these avenues of monitoring, AEs will be monitored more formally through several 
means of surveillance, including:
o
At each follow-up visit, data will be collected that includes assessment of interim
symptoms, concomitant medication use and any new illnesses or conditions that have
occurred from the time of the previous visit.
o
Research data will be interrogated to identify whether any questionnaire data exceed
values that indicate an abnormality.
10.7 REPORTING ADVERSE EVENTS
HOW TO REPORT AN ADVERSE EVENT
In response to an adverse event, the research coordinator must fill out the Adverse Event Case 
Report Form and notify the PI. The PI will provide further instructions on a case-by-case basis.
10.8 FOLLOW-UP OF ADVERSE EVENTS
Effective Date: 5/19/2021
End Date: 5/17/2022

DURING THE STUDY
We will obtain signatures on a medical release form at enrollment, and then obtain any medical 
records throughout the duration of the patient’s experience of the adverse events. We will be 
regularly checking in with the patient and appropriately documenting all progress until the 
adverse event has been resolved. 
Effective Date: 5/19/2021
End Date: 5/17/2022

11 – DATA MANAGEMENT
11.1 REDCAP
We will store all data collected from forms on RedCAP.
11.2 ONCORE
All participant data will be stored on OnCore Clinical Trial Management Software. 
11.3 RIPPLE
All patient data for those who are ineligible or declined to participate will be stored in ripple.
11.4 ENCOREEVERYWHERE
All CPAP monitoring and compliance/adherence data will be stored on EncoreEverywhere.
11.5 CLOUDPAT
All sleep data will be stored on CloudPAT for the DMC to download and interpret.
Effective Date: 5/19/2021
End Date: 5/17/2022

12 – QUALITY ASSURANCE
12.1 QUALITY ASSURANCE PROCEDURES AND RESPONSIBILITIES
Quality control measures will be implemented at several levels to ensure that all centers and personnel 
meet and maintain comparable high levels of technical performance. Quality control will be optimized by 
multiple levels of training, monitoring, and feedback activities including coordinator training and 
certification of personnel for all specialized testing and monitoring procedures.
COORDINATOR TRAINING
After protocol and Manual of Procedures development, a training session will be held virtually on Zoom. 
Attendees will include study investigators, study coordinators, as well as the leaders of each 
subcommittee. Joint introductory sessions will be held that include a review of the entire protocol and 
study organization and allow study personnel to become acquainted. Specifically, but not exclusively, this 
training will ensure that all personnel understand the study’s goals and objectives, as well as PAP-COVID 
specific data collection and procedures, to ensure that the study is conducted appropriately. Breakout 
sessions will focus on specific aspects of data collection and database management; anthropometry; AE 
monitoring and reporting; recruitment and retention; and data entry and data management. Some sessions 
will be audio-recorded and/or videotaped for future references by staff. Time will be allotted to document 
proficiency in specific procedures, which may require combinations of observation by the trainer and 
written exams. In addition to the initial coordinator training, ongoing training of study staff will be 
conducted. This training, in the form of conference calls, is designed to maintain a current level of project 
knowledge regarding developments taking place after the initial coordinator training.
12.2 DATA INTEGRITY
INSPECTIONS AND AUDITS
Participation as an investigator in this study implies acceptance of potential inspection by applicable 
Institutional compliance and quality assurance offices. The investigator will permit study-related 
monitoring, audits, and inspections by the IRB, and Mount Sinai compliance and quality assurance groups 
of all study-related documents (e.g. source documents, regulatory documents, data collection 
instruments). The investigator will ensure the capability for inspections of applicable study-related 
facilities.
DATABASE AND SYSTEMS MANAGEMENT
The PI will routinely monitor data entered by the coordinators. The DMC and statisticians will check for 
data quality.
DATA RECOVERY
We will routinely backup the RedCAP databases so we have physical copies of the data.
Effective Date: 5/19/2021
End Date: 5/17/2022

13 – REGULATORY COMPLIANCE
13.1 RECORD KEEPING AND SOURCE DOCUMENTS
Source data consists of all information, original records of clinical findings, observations, or other 
activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are 
contained in source documents. Examples of these original (source) documents and data records include:
•
Hospital records;
•
Clinical and office charts;
•
Laboratory notes;
•
Evaluation checklists;
•
Pharmacy records;
•
Death records;
•
Recorded data from automated instruments;
•
Copies or transcriptions certified after verification as being accurate and complete;
•
Photographic negatives;
•
Digital pictures;
•
Microfilm or magnetic media;
•
X-rays;
All patient information will remain in OnCore and RedCAP.
RECORD RETENTION
It is the investigator’s responsibility to retain essential study documents for at least seven years after the 
study is discontinued.
13.2 INSTITUTIONAL REVIEW BOARD
It is the responsibility of the Principal Investigator (PI)  to work with the IRB in initiating protocol 
approval and re-approval, notification of protocol and/or ICF changes, AEs, and termination of the study 
according to the appropriate IRB requirements.
13.3 CONTINUING REVIEWS
Effective Date: 5/19/2021
End Date: 5/17/2022

The study is expected to last less than one year, and before any continuing reviewing will be needed. In 
the event that we need to extend the study, a continuing review will be submitted in accordance with 
Mount Sinai’s IRB policies. 
APPENDICES
Effective Date: 5/19/2021
End Date: 5/17/2022

FORMS
SCREENING FORM
Effective Date: 5/19/2021
End Date: 5/17/2022

Screening Form
1. Source of participant’s referral? (check one)
□Mount Sinai Main ED
□Mount Sinai ED Surge Space
□ED Precision Recovery Program
□□EPIC
□□other means, specify: ____________________
Demographics and Subject History Form :
2. Patient’s demographic information was obtained via:
□Chart Abstraction □Oral Interview
3. participant’s current age? _________________
4. What is the participant’s biological sex?
□Male □Female
5. What is the participant’s race (check all that apply)?
□American Indian or Alaska Native
□Asian
□Black or African American
□White or Caucasian
□Native Hawaiian or Other Pacific Islander
□Other (please specify): ____________________
□Unknown or Not Reported
6. What is the participant’s ethnicity?
□Hispanic or Latino
□Not Hispanic or Latino
7. What is participant’s BMI? ___________________
Enrollment Eligibility Form:
Effective Date: 5/19/2021
End Date: 5/17/2022

ER ADMISSION DATA FORM
Effective Date: 5/19/2021
End Date: 5/17/2022

ER Admission Data Form
*This is abstracted from the chart, data from the date of their admission to the ER prior to baseline
1. Date of admission to the ER: ___________________
2. Time of admission to the ER: ___________________
3. Number of days since symptom onset: ____________
4. Source of COVID infection:
□Unknown
□Known
□Occupational
□Household
□Other: _____________
5. Did patient have any of the following symptoms (y/n):
□Fever (y/n)
□Cough (y/n)
□Shortness of breath (y/n)
□Chest tightness (y/n)
□Sputum (y/n)
□Nasal congestion (y/n)
□Sore throat (y/n)
□Chills (y/n)
□gastrointestinal symptoms (y/n)
Vital signs in the ED
6. Temperature Fahrenheit: _________
7. Oxygen saturation: _______________
□Without supplemental oxygen
□With supplemental oxygen
□How much supplemental oxygen? _______
□What method of oxygen: nasal canula, face mask, high flow nasal canula
8. Blood pressure: ______/______
9. Pulse: _________
Effective Date: 5/19/2021
End Date: 5/17/2022

Effective Date: 5/19/2021
End Date: 5/17/2022

VISITS FIGURE
Effective Date: 5/19/2021
End Date: 5/17/2022

VISITS FIGURE
Visit 1
Visit 2 
Equipment 
Set Up 
Call
6-12 
hrs
18-24 
hrs
30-36 
hrs
42-48 
hrs
54-60 
hrs
66-72 
hrs
Daily
Days 4-7 
(CPAP only)
Daily
Days 4-7
(no CPAP)
Everyone 
Days
8-14, 28
Event 
Driven
Phone consent with 
witness (Consent 
Form)
✓
Screening
✓
Enrollment Eligibility 
Form
✓
ER Admission Data 
Form
✓
Demographics and 
Subject History Form
✓
Participant Contact 
Form
✓
Medications Form
✓
CPAP and WatchPat 
Assignment Form
✓
PROMIS 
questionnaire Form
✓
Randomization Form
✓
CPAP Set up Form
✓
Effective Date: 5/19/2021
End Date: 5/17/2022

WatchPAT and Pox 
Set up Form
✓
Follow-up 
Questionnaire
✓
✓
✓
✓
✓
✓
✓
Respiratory 
Questionnaire Form
✓
✓
✓
✓
✓
✓
✓
✓
✓
CPAP Adherence 
Form 
(Downloaded)
✓
✓
✓
✓
✓
✓
CPAP Use Form 
(For Patient)
✓
✓
✓
✓
✓
✓
WatchPAT 
Download Form
Adverse Event 
Report Form
✓
Discontinuation Form
✓
Interval Assessment 
Form
✓
Protocol 
Deviation/Violation
✓
End of Study Form
✓
Investigator 
Statement Form 
(Day 28)
✓
Effective Date: 5/19/2021
End Date: 5/17/2022