Trial Outcomes & Findings for Early CPAP in COVID-19 Confirmed or Suspected Patients (NCT NCT04390191)

NCT ID: NCT04390191

Last Updated: 2022-09-28

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 4 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2022-09-28

Participant Flow

Enrollment period from May 2020 to July 2021

Participant milestones

Measure	Continuous Positive Airway Pressure (CPAP) Continuous Positive Airway Pressure: CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc).	Control Patients in this arm was not be given any intervention and will be monitored for 72 hours continuously, and then daily for a total of 14 days.
Overall Study STARTED	1	3
Overall Study COMPLETED	0	3
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Continuous Positive Airway Pressure (CPAP) Continuous Positive Airway Pressure: CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc).	Control Patients in this arm was not be given any intervention and will be monitored for 72 hours continuously, and then daily for a total of 14 days.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Early CPAP in COVID-19 Confirmed or Suspected Patients

Baseline characteristics by cohort

Measure	Continuous Positive Airway Pressure (CPAP) n=1 Participants Continuous Positive Airway Pressure: CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc).	Control n=3 Participants Patients in this arm was not be given any intervention and will be monitored for 72 hours continuously, and then daily for a total of 14 days.	Total n=4 Participants Total of all reporting groups
Age, Continuous	30 years STANDARD_DEVIATION 0 • n=5 Participants	54.67 years STANDARD_DEVIATION 12.01 • n=7 Participants	48.50 years STANDARD_DEVIATION 15.76 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Continuous Positive Airway Pressure (CPAP) n=1 Participants Continuous Positive Airway Pressure: CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc).	Control n=3 Participants Patients in this arm was not be given any intervention and will be monitored for 72 hours continuously, and then daily for a total of 14 days.
Number of Participants Who Met the Efficacy Endpoint	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 14 days from randomization

Number of Participant with an admission to the intensive care unit within 14 days from randomization

Outcome measures

Measure	Continuous Positive Airway Pressure (CPAP) n=1 Participants Continuous Positive Airway Pressure: CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc).	Control n=3 Participants Patients in this arm was not be given any intervention and will be monitored for 72 hours continuously, and then daily for a total of 14 days.
Number of Participants Admitted to the ICU	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 14 days from randomization

Population: No participants intubated.

The time from randomization to the patient needing to be intubated and needing mechanical ventilation within 14 days from randomization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14-28 days from randomization

Mortality Rate - the number of deaths within 14 and 28 days from randomization

Outcome measures

Measure	Continuous Positive Airway Pressure (CPAP) n=1 Participants Continuous Positive Airway Pressure: CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc).	Control n=3 Participants Patients in this arm was not be given any intervention and will be monitored for 72 hours continuously, and then daily for a total of 14 days.
Number of Deaths at 14 Day and 28 Day Mortality 14 days after randomization	0 Participants	0 Participants
Number of Deaths at 14 Day and 28 Day Mortality 28 days after randomization	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 14 days from randomization

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

Outcome measures

Measure	Continuous Positive Airway Pressure (CPAP) n=1 Participants Continuous Positive Airway Pressure: CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc).	Control n=3 Participants Patients in this arm was not be given any intervention and will be monitored for 72 hours continuously, and then daily for a total of 14 days.
Conversion of COVID Household Members in CPAP vs Control	0 household members	0 household members

SECONDARY outcome

Timeframe: baseline and 14 days from randomization

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.

Outcome measures

Measure	Continuous Positive Airway Pressure (CPAP) n=1 Participants Continuous Positive Airway Pressure: CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc).	Control n=3 Participants Patients in this arm was not be given any intervention and will be monitored for 72 hours continuously, and then daily for a total of 14 days.
Change in Clinical COPD Questionnaire (CCQ)	-11 score on a scale	4.6 score on a scale Interval -5.0 to 15.0

SECONDARY outcome

Timeframe: 7 days from randomization

Population: CPAP arm only

Number of the patients in the CPAP arm elect to continue using the CPAP after the initial 72 hour period.

Outcome measures

Measure	Continuous Positive Airway Pressure (CPAP) n=1 Participants Continuous Positive Airway Pressure: CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc).	Control Patients in this arm was not be given any intervention and will be monitored for 72 hours continuously, and then daily for a total of 14 days.
Number of Patients Electing to Continue CPAP for Greater Than 72 Hours	1 Participants	—

SECONDARY outcome

Timeframe: 14 days from randomization

The number of participants with improvement in oxygen saturation within 14 days of randomization.

Outcome measures

Measure	Continuous Positive Airway Pressure (CPAP) n=1 Participants Continuous Positive Airway Pressure: CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc).	Control n=3 Participants Patients in this arm was not be given any intervention and will be monitored for 72 hours continuously, and then daily for a total of 14 days.
Number of Participants With Improvement in Oxygen Saturation	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 14 days from randomization

Number of participants with hospital admission or ED within 14 days of randomization

Outcome measures

Measure	Continuous Positive Airway Pressure (CPAP) n=1 Participants Continuous Positive Airway Pressure: CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc).	Control n=3 Participants Patients in this arm was not be given any intervention and will be monitored for 72 hours continuously, and then daily for a total of 14 days.
Number of Participants With Hospital Admission or ED	0 Participants	1 Participants

Adverse Events

Continuous Positive Airway Pressure (CPAP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Continuous Positive Airway Pressure (CPAP) n=1 participants at risk Continuous Positive Airway Pressure: CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc).	Control n=3 participants at risk Patients in this arm was not be given any intervention and will be monitored for 72 hours continuously, and then daily for a total of 14 days.
Respiratory, thoracic and mediastinal disorders COVID pneumonitis	0.00% 0/1 • 28 days. Patients were followed for 28 days and as a secondary endpoint, we assessed 28 day mortality and for late impact of CPAP. The control subject who was admitted to the ER for an adverse event still completed the study. The subject was routinely contacted and completed study questionnaires. The adverse event was considered as an outcome and he was not withdrawn from the study.	33.3% 1/3 • 28 days. Patients were followed for 28 days and as a secondary endpoint, we assessed 28 day mortality and for late impact of CPAP. The control subject who was admitted to the ER for an adverse event still completed the study. The subject was routinely contacted and completed study questionnaires. The adverse event was considered as an outcome and he was not withdrawn from the study.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Neomi Shah

Icahn School of Medicine at Mount Sinai

Phone: 212-241-6286

Email: neomi.shah@mssm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place