Clinical trial NCT04800120: Use of Hyperbaric Oxygen Therapy to Treat COVID-19 Patients With Respiratory Distress
Official title: The Use of Hyperbaric Oxygen Therapy (HBOT) for the Treatment of COVID-19 Patients With Mild-to-moderate Respiratory Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Study Group: Provide 100% oxygen at 2.0 ATA for 90 minutes on consecutive days for a total of up to 5 treatment to COVID-19 patients meeting inclusion criteria Control Group: Any COVID-19 positive patient meeting study inclusion criteria that does not receive HBOT (historical)
Primary purpose: TREATMENT

Brief summary: Investigate whether hyperbaric oxygen therapy treatment can become a viable treatment option for COVID-19. If successful, providers will be able to provide future COVID-19 patients with mild-to-moderate respiratory distress hyperbaric oxygen therapy in order to help avoid mechanical ventilation

Detailed description: Using the Monoplace Hyperbaric Oxygen Chambers we will be providing COVID- 19 positive patients with mild-to-moderate distress 100% oxygen at 2.0 ATA for 90 minutes on consecutive days for a total of up to 5 treatments. A comparison will be made using a historical cohort not receiving HBOT. Data will be collected to determine whether or not HBOT is of any benefit to COVID-19 positive patient with mild-to-moderate respiratory distress.

Study Group: Provide 100% oxygen at 2.0 ATA for 90 minutes on consecutive days for a total of up to 5 treatment to COVID-19 patients meeting inclusion criteria Control Group: Any COVID-19 positive patient meeting study inclusion criteria that does not receive HBOT (historical) The control group is further defined as patients who were previously treated for COVID-19 at Morton Hospital that did not receive hyperbaric oxygen therapy. This will require accessing medical records to obtain patient information to establish the historical control data metric.

Study outcome measures:

* Time to normalize 02 requirement (ambient air pulse ox greater than or equal to 92% or ABG w/Pa02 greater than 60mmHG on air)
* Mortality
* Days free of invasive mechanical ventilation

Eligibility criteria: Inclusion Criteria:

* Verified COVID-19 infection
* Patient w/02 dependence of less than or equal to 6 liter/min to maintain pulse ox greater than or equal to 92% or arterial gas w/PA02 greater than 60mm HG

Exclusion Criteria:

* Not diagnosed w/COVID-19 infection
* Pregnancy
* DNR or other restrictions in escalation of level of care
* Contraindication for HBO
* Blood pressure parameters which are deemed unstable by clinical team
* Patients who require continuous ECG and/or continuous blood pressure monitoring, and with arterial lines
* Patients requiring rewarming
* Patients requiring any kind of invasive catheter/pressure monitoring
* Patients requiring continuous support of intravenous medication
* Minor subject (less than 18 years old)
* Refusal to participate
* Signs of respiratory decompensation requiring intubation and mechanical ventilation
* 02 dependence greater than or equal to 6L/minute to obtain Sa02 greater than or equal to 92% or ABG w/Pa02 \>60mmHg

Primary outcomes:
measure: Normalization of oxygen
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Mortality
timeFrame: through study completion, an average of 1 year
measure: Days free of invasive mechanical ventilation
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Taunton
country: United States
facility: Morton Hospital
state: Massachusetts
Study officials:
affiliation: Steward Healthcare
name: Jill Trelease, DNP
role: PRINCIPAL_INVESTIGATOR
References: