Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

NCT06082518 | Recruiting FDA Device

• 1 other identifier: 5825
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Over 500 million people have been infected with COVID-19, and to date, more than 6 million people have died. Many individuals who have recovered from COVID-19 continue to experience symptoms even after they have been "cured" of the disease. This condition is known as post COVID-19 condition, which can have serious health consequences. A common symptom among these individuals is chronic fatigue, characterized by persistent tiredness or lack of energy. This study aims to explore a novel treatment for symptoms of post COVID-19 condition, known as hyperbaric oxygen therapy. This approach has shown promise in helping people with post COVID-19 conditions and treating some other causes of fatigue. Hyperbaric oxygen therapy involves placing patients in a small chamber where they receive high oxygen gas levels. However, this treatment is expensive and time-consuming, and it is unclear if this treatment can be effectively assessed in a large-scale research study. This small study will help us decide if conducting a large research study is feasible. The investigators aim to assess if hyperbaric oxygen therapy can improve symptoms of post COVID-19 condition, such as fatigue.

Conditions

Post COVID-19 Condition; Post-COVID-19 Syndrome; Post-COVID Syndrome; COVID-19; Fatigue; Fatigue Syndrome, Chronic

Keywords

Hyperbaric Oxygen Therapy; HBOT; Post COVID-19 Condition; Fatigue; Severe Acute Respiratory Syndrome-CoV-2; COVID-19

Outcome Measures

Primary Outcomes (6)

• Recruitment rate - referral

  Quantify referral rate from healthcare providers

  9 months

• Recruitment rate - inclusion

  Number of patients meeting inclusion criteria

  9 months

• Recruitment rate - consent

  Patient consent rate

  9 months

• Adherence to HBOT protocol

  Number of Participants received minimum 4 treatments per week with \>35 treatments

  9 months recruitment + 8 weeks treatment

• Adherence to HBOT protocol - satisfaction

  Subjective patient satisfaction questionnaire inquiring about HBOT experience, barriers to and promoters of treatment

  After last HBOT treatment and at 12 month follow-up

• Feasibility of Clinical Outcome Measures

  Feasibility of implementation of clinical outcome scales (PDQ, FSS, SF-36) to be completed at the time of enrollment (baseline), start of treatment (if starting 60 days after enrollment), 4 weeks after the start of treatment, and every 2 months from the first HBOT treatment for 1 year.

  Up to 1 year after start of treatment

Secondary Outcomes (12)

• The impact of HBOT on post COVID-19 condition - PDQ

  Up to 1 year after start of treatment

• The impact of HBOT on post COVID-19 condition - FSS

  Up to 1 year after start of treatment

• The impact of HBOT on post COVID-19 condition - SF-36

  Up to 1 year after start of treatment

• The impact of time to initiation of HBOT on outcomes following initial infection outcome - PDQ

  Up to 1 year after start of treatment

• The impact of time to initiation of HBOT on outcomes following initial infection outcome - FSS

  Up to 1 year after start of treatment

Study Arms (2)

Immediate start of hyperbaric treatments

EXPERIMENTAL

HBOT treatments will be scheduled to start immediately after referral.

Device: Monoplace Hyperbaric Chamber (Class III medical device).

Delayed start of hyperbaric treatments

EXPERIMENTAL

HBOT treatments will be scheduled to start 60 days after referral.

Device: Monoplace Hyperbaric Chamber (Class III medical device).

Interventions

Monoplace Hyperbaric Chamber (Class III medical device). DEVICE

40 hyperbaric oxygen therapy (HBOT) treatments (90 minute exposures at 2 atmospheres (ATM) per treatment), scheduled daily from Monday to Friday (i.e., 5 treatments per week) until treatments are completed (approximately 8 weeks). Treatments will be delivered in a medical grade, Health Canada-approved monoplace hyperbaric chamber and overseen by specialist hyperbaric physicians and a Certified Hyperbaric Technologist. Device is being used in manner consistent with approved usage in Canada.

Delayed start of hyperbaric treatments; Immediate start of hyperbaric treatments

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old
• Officially diagnosed with post COVID-19 condition by a healthcare practitioner
• At least three months since SARS-CoV-2 infection
• Symptoms that persist more than 12 weeks:
• Chronic fatigue (must include) along with one of the following symptoms:
• Difficulty thinking or problem solving ('brain fog')
• Stress or anxiety

You may not qualify if:

• Contraindications/medically unfit to receive hyperbaric treatments at an outpatient facility (pneumothorax, in-patients, requiring infusions to maintain hemodynamics, active and unstable coronary disease)
• Patients with cognitive difficulties and/or mental retardation before COVID diagnosis
• History of traumatic brain injury
• Unlikely to comply with follow-up assessments (e.g. no fixed address, plans to move out of town)
• Known pregnancy or planning a pregnancy in women of childbearing age

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19; Fatigue; Fatigue Syndrome, Chronic

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; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Fahad Alam, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Jordan Tarshis, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fahad Alam, MD

CONTACT

416-480-4864; fahad.alam@sunnybrook.ca

Lilia Kaustov, PhD

CONTACT

416 480-6100; lilia.kaustov@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Specialist hyperbaric physicians, blinded to group allocation, will provide treatment and follow patients daily throughout their treatment course. Outcomes Assessor will also be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: October 13, 2023
• Study Start: January 2, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon publication, no limit on time.
• Access Criteria: Contact directly study principal investigators.

Locations

CA (1)