Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial - Effect of Hyperbaric Oxygen Therapy for the Treatment of Post COVID Condition

NCT06452095 | Recruiting DMC

• 1 other identifier: 21-6203-HBOT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The RECLAIM study platform will be used to explore whether the use of Hyperbaric Oxygen therapy (HBOT) improves the symptoms of post covid cognitive dysfunction. Hyperbaric oxygen therapy is a well-established medical treatment. HBOT promotes healing by delivering a high concentration of oxygen into the body. This high level of oxygen has a number of known benefits, such as growth of new blood vessels, as well as regulating immune and inflammation responses. It helps protect the brain and other nervous tissue from inflammation. HBOT may also have antiviral effects. Collectively, it has the potential to target the underlying mechanisms believed to play a critical role in the development of Long COVID. Many individuals with Long COVID complain of fatigue, brain fog, muscle aches and other symptoms. There is evidence to suggest that these symptoms may be a problem with the blood vessels, resulting in abnormal delivery of oxygen to tissues. Thus, our group is investigating whether HBOT improves post-COVID cognitive dysfunction.

Conditions

Long COVID; Post Acute Sequelae of COVID-19; Post-COVID-19 Condition

Outcome Measures

Primary Outcomes (2)

• Simple reaction time [SRT] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit

  On-line survey tool

  Baseline/Start of intervention to two months

• Verbal paired associates [VPA] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit

  On-line survey tool

  Baseline/Start of intervention to two months

Secondary Outcomes (14)

• Symptoms scale

  Baseline/start of intervention weekly to 2 months, then once monthly to 6 months.

• Symptom Checklist

  Baseline/start of intervention to 1, 2 months 3 and 6 months

• Six Minute Walking Test (6MWT) with oximetry

  Baseline/start of intervention and 2 months.

• SF-36

  Baseline/start of intervention to 1, 2 months 3 and 6 months

• TestMyBrain cognitive testing

  Baseline/start of intervention to 1, 2 months 3 and 6 months

Study Arms (2)

Hyperbaric oxygen therapy

EXPERIMENTAL

HBOT GROUP will have HBOT with 100% oxygen for 90 min, once daily, five times a week for 8 consecutive weeks. This will be given at a slightly higher pressure than normal air pressure (2 times regular air pressure)

Device: Hyperbaric Oxygen therapy

Hyperbaric oxygen sham

SHAM COMPARATOR

CONTROL GROUP will have sham treatment, which will look and feel like HBOT, but will not have high enough oxygen concentration for any therapeutic or health benefit. Sham treatment with 21% oxygen (the amount of oxygen normally present in the air) for 90 min, once daily, five times a week for 8 consecutive weeks. This will be given at standard atmospheric pressure (1.03 ATA). The air pressure will vary slightly to mimic the feeling of HBOT.

Device: Hyperbaric Oxygen therapy

Interventions

Hyperbaric Oxygen therapy DEVICE

The SECHRIST INDUSTRIES mono-place Hyperbaric Chambers OR Sigma Series mono-place Hyperbaric Chambers

Hyperbaric oxygen sham; Hyperbaric oxygen therapy

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;
• Positive COVID-19 test by nasopharyngeal swab RT-PCR (reverse transcription polymerase chain reaction) test, antibody or antigen tests at least 3 months prior to randomization; OR Presumed COVID-19 assessed by the site investigator (no positive COVID-19 test) with acute illness after October 15, 2019.
• Patients should be treated with standard of care therapies (as discussed in the study manual) for at least 4 weeks prior to entry into trial.
• Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive test or the date of first symptoms;
• Lingering symptoms from COVID-19 present at the time of randomization. "Lingering symptoms of Long COVID" must include self-reported cognitive dysfunction symptoms.
• Female patients of childbearing potential (as assessed by the overseeing Investigator) who are sexually active must agree to practice true abstinence or use effective methods of contraception while on study treatment. Effective methods of contraception must be discussed and approved by the overseeing Investigator.
• Must be able to provide informed consent and both willing and able to comply with study requirements.
• A confirmed ability to travel to one of the three sites where HBOT or sham can be administered.

You may not qualify if:

• Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19;
• Current end-organ failure, organ transplantation, or current hospitalization in acute care hospital;
• Contraindications to all of the study interventions;
• Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted);
• Currently pregnant or breastfeeding.
• Pneumothorax
• Poorly controlled seizure disorder
• Chronic sinusitis
• Chronic or acute otitis media
• Major ear drum trauma.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

COVID-19; 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

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Angela M Cheung, MD, PhD

  University Health Network, Toronto

  STUDY DIRECTOR

• Rita Katznelson, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RECLAIM CONTACT RECLAIM contact line

CONTACT

1-866-673-2524; reclaim@uhn.ca

Andrew Janes, MSc

CONTACT

andrew.janes@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to intervention in so far as the HBOT experience will be similar between treatment and sham arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RECLAIM is a Canada-wide phase ll/lll, prospective, adaptive randomized controlled platform trial that is intended to study various interventions for patients with long COVID. Interventional arms may be discontinued based on interim analysis results and new interventions may be selected and included as part of the platform as the trial progresses. As such, the protocol and consent documents are a modular design. The HBOT arm includes: * Master Protocol and informed consent documents: Contain information applicable to the whole platform. * HBOT Sub-Protocol: Contain additional information, specific to the HBOT interventional arm.

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 11, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

CA (1)