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Hyperbaric Oxygen for COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04332081
Recruitment Status : Terminated (The IRB has determined that the design of this trial should be changed to a randomized controlled trial. A new record will be created for the redesigned study.)
First Posted : April 2, 2020
Results First Posted : June 22, 2021
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition COVID-19
Intervention Device: hyperbaric oxygen therapy (HBOT)
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hyperbaric Oxygen Therapy (HBOT) Standard of Care
Hide Arm/Group Description 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. No HBOT
Period Title: Overall Study
Started 20 60
Completed 20 60
Not Completed 0 0
Arm/Group Title Hyperbaric Oxygen Therapy (HBOT) Standard of Care Total
Hide Arm/Group Description 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. No HBOT Total of all reporting groups
Overall Number of Baseline Participants 20 60 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 60 participants 80 participants
58
(30 to 79)
62
(24 to 80)
60
(24 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 60 participants 80 participants
Female
2
  10.0%
5
   8.3%
7
   8.8%
Male
18
  90.0%
55
  91.7%
73
  91.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 60 participants 80 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
20
 100.0%
60
 100.0%
80
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 60 participants 80 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.0%
6
  10.0%
7
   8.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  15.0%
10
  16.7%
13
  16.3%
White
7
  35.0%
16
  26.7%
23
  28.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
9
  45.0%
28
  46.7%
37
  46.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 60 participants 80 participants
20 60 80
1.Primary Outcome
Title Mortality
Hide Description [Not Specified]
Time Frame through study completion; an average of 50 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hyperbaric Oxygen Therapy (HBOT) Standard of Care
Hide Arm/Group Description:
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.
No HBOT
Overall Number of Participants Analyzed 20 60
Measure Type: Number
Unit of Measure: % of participants
10 22
2.Secondary Outcome
Title Need for Mechanical Ventilation
Hide Description [Not Specified]
Time Frame through study completion; an average of 50 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hyperbaric Oxygen Therapy (HBOT) Standard of Care
Hide Arm/Group Description:
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.
No HBOT
Overall Number of Participants Analyzed 20 60
Measure Type: Count of Participants
Unit of Measure: Participants
2
  10.0%
18
  30.0%
Time Frame through study completion; an average of 50 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hyperbaric Oxygen Therapy (HBOT) Standard of Care
Hide Arm/Group Description 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. No HBOT
All-Cause Mortality
Hyperbaric Oxygen Therapy (HBOT) Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   2/20 (10.00%)      13/60 (21.67%)    
Hide Serious Adverse Events
Hyperbaric Oxygen Therapy (HBOT) Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      0/60 (0.00%)    
Respiratory, thoracic and mediastinal disorders     
Hypoxic Arrest *  1/20 (5.00%)  1 0/60 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hyperbaric Oxygen Therapy (HBOT) Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/60 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Lee
Organization: NYU Langone
Phone: 212-263-3293
EMail: David.lee@nyulanogne.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04332081    
Other Study ID Numbers: 20-00399
First Submitted: March 30, 2020
First Posted: April 2, 2020
Results First Submitted: June 14, 2021
Results First Posted: June 22, 2021
Last Update Posted: June 22, 2021