COVID-19
Conditions
Brief summary
Hyperbaric oxygen therapy (HBOT) treatment will be provided to patients as an adjunct to standard therapy for a cohort of 40 COVID19-positive patients with respiratory distress at NYU Winthrop Hospital. All patients prior to the clinical application of HBOT will be evaluated by the primary care team and hyperbaric physician. After the intervention portion of this study, a chart review will be performed to compare the outcomes of intervention patients versus patients who received standard of care.
Detailed description
This is a single center prospective pilot cohort study to evaluate the safety and efficacy of hyperbaric oxygen therapy (HBOT) as an emergency investigational device for treating patients with a novel coronavirus, disease, COVID-19. Patients that meet inclusion criteria will be consented by the hyperbaric physician. They will then be transported from the ED or other unit to the hyperbaric unit maintaining airborne precautions based on the most current hospital protocol. All study personnel will have proper PPE at all times. The patient will then be placed into the monoplace chamber and when the chamber door is closed the patient will remove any respiratory filter/mask that was placed. 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 medical 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. After the intervention portion of this study, a chart review will be performed to compare the outcomes of intervention patients versus patients who received standard of care.
Interventions
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.
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective pilot cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Male or female, age \> 18 years 2. Positive COVID 19 test 3. Respiratory compromise defined by SpO2 \<93% 4. Ability to sign informed consent
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study: 1. Pregnancy 2. Untreated Pneumothorax
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality | through study completion; an average of 50 days |
Secondary
| Measure | Time frame |
|---|---|
| Need for Mechanical Ventilation | through study completion; an average of 50 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Standard of Care No HBOT | 60 |
| Total | 80 |
Baseline characteristics
| Characteristic | Hyperbaric Oxygen Therapy (HBOT) | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 58 years | 60 years | 62 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 80 Participants | 60 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 7 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 13 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 37 Participants | 28 Participants |
| Race (NIH/OMB) White | 7 Participants | 23 Participants | 16 Participants |
| Region of Enrollment United States | 20 participants | 80 participants | 60 participants |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 18 Participants | 73 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 20 | 13 / 60 |
| other Total, other adverse events | 0 / 20 | 0 / 60 |
| serious Total, serious adverse events | 1 / 20 | 0 / 60 |
Outcome results
Primary
Mortality
Time frame: through study completion; an average of 50 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hyperbaric Oxygen Therapy (HBOT) | Mortality | 10 % of participants |
| Standard of Care | Mortality | 22 % of participants |
Secondary
Need for Mechanical Ventilation
Time frame: through study completion; an average of 50 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hyperbaric Oxygen Therapy (HBOT) | Need for Mechanical Ventilation | 2 Participants |
| Standard of Care | Need for Mechanical Ventilation | 18 Participants |