Use of Hyperbaric Oxygen Therapy to Treat COVID-19 Patients With Respiratory Distress

NCT04800120 | Completed

• 1 other identifier: IRB Protocol #00800
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Normalization of oxygen

  normalize 02 requirement (ambient air pulse ox greater than or equal to 92% or ABG w/Pa02 greater than 60mmHG on air)

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Mortality

  through study completion, an average of 1 year

• Days free of invasive mechanical ventilation

  through study completion, an average of 1 year

Study Arms (2)

Study Group

ACTIVE COMPARATOR

Identified COVID 19 patients receiving the intervention of Hyperbaric Oxygen Therapy

Other: Hyperbaric Oxygen Therapy

Control Group

NO INTERVENTION

Historical control of COVID 19 patients who were previously treated and did not receiving Hyperbaric Oxygen Therapy

Interventions

Hyperbaric Oxygen Therapy OTHER

Delivery of 100% oxygen within a hyperbaric oxygen therapy chamber

Also known as: HBOT

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• dependence greater than or equal to 6L/minute to obtain Sa02 greater than or equal to 92% or ABG w/Pa02 \>60mmHg

Sponsors & Collaborators

• Steward St. Elizabeth's Medical Center of Boston, Inc.: lead

Study Sites (1)

Morton Hospital

Taunton, Massachusetts, 02780, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Jill Trelease, DNP

  Steward Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: March 16, 2021
• Study Start: February 15, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)