Trial Outcomes & Findings for Hyperbaric Oxygen for COVID-19 Patients (NCT NCT04332081)

NCT ID: NCT04332081

Last Updated: 2021-06-22

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: through study completion; an average of 50 days
• Results posted on: 2021-06-22

Participant Flow

Participant milestones

Measure	Hyperbaric Oxygen Therapy (HBOT) hyperbaric oxygen therapy (HBOT): The patient will receive 90 minutes of hyperbaric oxygen at 2.0 ATA with or without airbreaks per the hyperbaric physician. Upon completion of the treatment the patient will then return to the medial unit and continue all standard of care. Additional treatments (up to 5) can be given if warranted and agreed upon by the patient and all members of the team caring for the patient.	Standard of Care No HBOT
Overall Study STARTED	20	60
Overall Study COMPLETED	20	60
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hyperbaric Oxygen for COVID-19 Patients

Baseline characteristics by cohort

Measure	Hyperbaric Oxygen Therapy (HBOT) n=20 Participants hyperbaric oxygen therapy (HBOT): The patient will receive 90 minutes of hyperbaric oxygen at 2.0 ATA with or without airbreaks per the hyperbaric physician. Upon completion of the treatment the patient will then return to the medial unit and continue all standard of care. Additional treatments (up to 5) can be given if warranted and agreed upon by the patient and all members of the team caring for the patient.	Standard of Care n=60 Participants No HBOT	Total n=80 Participants Total of all reporting groups
Age, Continuous	58 years n=5 Participants	62 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	55 Participants n=7 Participants	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	60 Participants n=7 Participants	80 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	1 Participants n=5 Participants	6 Participants n=7 Participants	7 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	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	16 Participants n=7 Participants	23 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	9 Participants n=5 Participants	28 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	60 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: through study completion; an average of 50 days

Outcome measures

Measure	Hyperbaric Oxygen Therapy (HBOT) n=20 Participants hyperbaric oxygen therapy (HBOT): The patient will receive 90 minutes of hyperbaric oxygen at 2.0 ATA with or without airbreaks per the hyperbaric physician. Upon completion of the treatment the patient will then return to the medial unit and continue all standard of care. Additional treatments (up to 5) can be given if warranted and agreed upon by the patient and all members of the team caring for the patient.	Standard of Care n=60 Participants No HBOT
Mortality	10 % of participants	22 % of participants

SECONDARY outcome

Timeframe: through study completion; an average of 50 days

Outcome measures

Measure	Hyperbaric Oxygen Therapy (HBOT) n=20 Participants hyperbaric oxygen therapy (HBOT): The patient will receive 90 minutes of hyperbaric oxygen at 2.0 ATA with or without airbreaks per the hyperbaric physician. Upon completion of the treatment the patient will then return to the medial unit and continue all standard of care. Additional treatments (up to 5) can be given if warranted and agreed upon by the patient and all members of the team caring for the patient.	Standard of Care n=60 Participants No HBOT
Need for Mechanical Ventilation	2 Participants	18 Participants

Adverse Events

Hyperbaric Oxygen Therapy (HBOT)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 2 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 13 deaths

Serious adverse events

Measure	Hyperbaric Oxygen Therapy (HBOT) n=20 participants at risk hyperbaric oxygen therapy (HBOT): The patient will receive 90 minutes of hyperbaric oxygen at 2.0 ATA with or without airbreaks per the hyperbaric physician. Upon completion of the treatment the patient will then return to the medial unit and continue all standard of care. Additional treatments (up to 5) can be given if warranted and agreed upon by the patient and all members of the team caring for the patient.	Standard of Care n=60 participants at risk No HBOT
Respiratory, thoracic and mediastinal disorders Hypoxic Arrest	5.0% 1/20 • Number of events 1 • through study completion; an average of 50 days	0.00% 0/60 • through study completion; an average of 50 days

Other adverse events

Adverse event data not reported

Additional Information

David Lee

NYU Langone

Phone: 212-263-3293

Email: David.lee@nyulanogne.org

Results disclosure agreements

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