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Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments (PCS-HBOT)

Primary Purpose

Post COVID-19 Condition, Post-COVID-19 Syndrome, Post-COVID Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Monoplace Hyperbaric Chamber (Class III medical device).
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post COVID-19 Condition focused on measuring Hyperbaric Oxygen Therapy, HBOT, Post COVID-19 Condition, Fatigue, SARS-CoV-2, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Known pregnancy or planning a pregnancy in women of childbearing age Exclusion Criteria: 1) Contraindications/medically unfit to receive hyperbaric treatments at an outpatient facility (pneumothorax, in-patients, requiring infusions to maintain hemodynamics, active and unstable coronary disease) 2) Patients with cognitive difficulties and/or mental retardation before COVID diagnosis 3) History of traumatic brain injury 4) Unlikely to comply with follow-up assessments (e.g. no fixed address, plans to move out of town) -

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate start of hyperbaric treatments

Delayed start of hyperbaric treatments

Arm Description

HBOT treatments will be scheduled to start immediately after referral.

HBOT treatments will be scheduled to start 90 days after referral.

Outcomes

Primary Outcome Measures

Recruitment rate - referral
Quantify referral rate from healthcare providers
Recruitment rate - inclusion
Number of patients meeting inclusion criteria
Recruitment rate - consent
Patient consent rate
Adherence to HBOT protocol
Number of Participants received minimum 4 treatments per week with >35 treatments
Adherence to HBOT protocol - satisfaction
Subjective patient satisfaction questionnaire inquiring about HBOT experience, barriers to and promoters of treatment

Secondary Outcome Measures

The impact of HBOT on post COVID-19 condition - PDQ
The validated clinical deficit scale will be used: Perceived Deficits Questionnaire (PDQ)
The impact of HBOT on post COVID-19 condition - FSS
The validated clinical deficit scale will be used: Fatigue Severity Scale (FSS)
The impact of HBOT on post COVID-19 condition - SF-36
The validated clinical deficit scale will be used: QoL Short Form Survey (SF-36)
The impact of time to initiation of HBOT on outcomes following initial infection outcome - PDQ
Validated clinical deficit scales PDQ will be compared with FSS and SF-36 between immediate and delayed start groups
The impact of time to initiation of HBOT on outcomes following initial infection outcome - FSS
Validated clinical deficit scale FSS will be compared with PDQ and SF-36 between immediate and delayed start groups
The impact of time to initiation of HBOT on outcomes following initial infection outcome - SF-36
Validated clinical deficit scale SF-36 will be compared with PDQ and FSS between immediate and delayed start groups
Initial infection severity as a mediator of HBOT impact - PDQ
Validated clinical deficit scale PDQ will be compared relative to baseline scores
Initial infection severity as a mediator of HBOT impact - FSS
Validated clinical deficit scale FSS will be compared relative to baseline scores
Initial infection severity as a mediator of HBOT impact - SF-36
Validated clinical deficit scale SF-36 will be compared relative to baseline scores
Long-term symptomatic impact at 1 year - PDQ
Assessed using validated clinical deficit scale PDQ at 12 months after treatment referral
Long-term symptomatic impact at 1 year - FSS
Assessed using validated clinical deficit scale FSS at 12 months after treatment referral
Long-term symptomatic impact at 1 year - SF-36
Assessed using validated clinical deficit scales SF-36 at 12 months after treatment referral

Full Information

First Posted
September 11, 2023
Last Updated
October 12, 2023
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT06082518
Brief Title
Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments
Acronym
PCS-HBOT
Official Title
Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments (PCS-HBOT Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Over 500 million individuals worldwide have contracted COVID-19. Among those that have 'recovered' from the acute infection, many suffer from post-COVID-19 condition (experiencing 1 or more symptoms 3 months from the onset of acute COVID-19 infection, with symptoms lasting at least 2 months). Many of these common symptoms, including fatigue, myalgia, and difficulty focusing ('brain fog'), can seriously compromise one's quality of life. Existing treatments predominantly focus on supportive management and specific symptom control, and most approaches have mixed or limited effectiveness. Recently, hyperbaric oxygen therapy (HBOT), acknowledged for its anti-inflammatory effects, has emerged as a potential treatment for post-COVID-19 condition symptoms. However, HBOT is time and resource-intensive, requiring between 20-40 daily treatments. Therefore, the feasibility of assessing HBOT efficacy via a large-scale randomized controlled trial is still being determined. Hence, this study aims to evaluate adherence to the protocol and the feasibility of proceeding with the full trial. The goal of the full trial will be to evaluate the impact of HBOT treatment on post-COVID-19 condition symptoms. This prospective, crossover, randomized pilot trial enrolls adult patients officially diagnosed with post-COVID-19 condition by a healthcare practitioner who continue to experience symptoms, particularly fatigue, at least 3 months following their initial COVID-19 infection. Participants will be assigned randomly (stratified by sex) to either begin HBOT treatments immediately or after a 90-day interval. All patients will be followed for 12 months from the initial treatment referral, with monthly assessments of post-COVID-19 condition symptoms (e.g. quality of life, fatigue) and participant satisfaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, SARS-CoV-2, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate start of hyperbaric treatments
Arm Type
Experimental
Arm Description
HBOT treatments will be scheduled to start immediately after referral.
Arm Title
Delayed start of hyperbaric treatments
Arm Type
Experimental
Arm Description
HBOT treatments will be scheduled to start 90 days after referral.
Intervention Type
Device
Intervention Name(s)
Monoplace Hyperbaric Chamber (Class III medical device).
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment rate - referral
Description
Quantify referral rate from healthcare providers
Time Frame
9 months
Title
Recruitment rate - inclusion
Description
Number of patients meeting inclusion criteria
Time Frame
9 months
Title
Recruitment rate - consent
Description
Patient consent rate
Time Frame
9 months
Title
Adherence to HBOT protocol
Description
Number of Participants received minimum 4 treatments per week with >35 treatments
Time Frame
9 months recruitment + 12 month follow-up
Title
Adherence to HBOT protocol - satisfaction
Description
Subjective patient satisfaction questionnaire inquiring about HBOT experience, barriers to and promoters of treatment
Time Frame
every 2-month intervals over 12 month follow-up
Secondary Outcome Measure Information:
Title
The impact of HBOT on post COVID-19 condition - PDQ
Description
The validated clinical deficit scale will be used: Perceived Deficits Questionnaire (PDQ)
Time Frame
Every two month until 1 year after treatment referral and completing HBOT treatments
Title
The impact of HBOT on post COVID-19 condition - FSS
Description
The validated clinical deficit scale will be used: Fatigue Severity Scale (FSS)
Time Frame
Every two month until 1 year after treatment referral and completing HBOT treatments
Title
The impact of HBOT on post COVID-19 condition - SF-36
Description
The validated clinical deficit scale will be used: QoL Short Form Survey (SF-36)
Time Frame
Every two month until 1 year after treatment referral and completing HBOT treatments
Title
The impact of time to initiation of HBOT on outcomes following initial infection outcome - PDQ
Description
Validated clinical deficit scales PDQ will be compared with FSS and SF-36 between immediate and delayed start groups
Time Frame
Every two month until 1 year after treatment referral
Title
The impact of time to initiation of HBOT on outcomes following initial infection outcome - FSS
Description
Validated clinical deficit scale FSS will be compared with PDQ and SF-36 between immediate and delayed start groups
Time Frame
Every two month until 1 year after treatment referral
Title
The impact of time to initiation of HBOT on outcomes following initial infection outcome - SF-36
Description
Validated clinical deficit scale SF-36 will be compared with PDQ and FSS between immediate and delayed start groups
Time Frame
Every two month until 1 year after treatment referral
Title
Initial infection severity as a mediator of HBOT impact - PDQ
Description
Validated clinical deficit scale PDQ will be compared relative to baseline scores
Time Frame
Every two month until 1 year after treatment referral
Title
Initial infection severity as a mediator of HBOT impact - FSS
Description
Validated clinical deficit scale FSS will be compared relative to baseline scores
Time Frame
Every two month until 1 year after treatment referral
Title
Initial infection severity as a mediator of HBOT impact - SF-36
Description
Validated clinical deficit scale SF-36 will be compared relative to baseline scores
Time Frame
Every two month until 1 year after treatment referral
Title
Long-term symptomatic impact at 1 year - PDQ
Description
Assessed using validated clinical deficit scale PDQ at 12 months after treatment referral
Time Frame
12 month follow-up
Title
Long-term symptomatic impact at 1 year - FSS
Description
Assessed using validated clinical deficit scale FSS at 12 months after treatment referral
Time Frame
12 month follow-up
Title
Long-term symptomatic impact at 1 year - SF-36
Description
Assessed using validated clinical deficit scales SF-36 at 12 months after treatment referral
Time Frame
12 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Known pregnancy or planning a pregnancy in women of childbearing age Exclusion Criteria: 1) Contraindications/medically unfit to receive hyperbaric treatments at an outpatient facility (pneumothorax, in-patients, requiring infusions to maintain hemodynamics, active and unstable coronary disease) 2) Patients with cognitive difficulties and/or mental retardation before COVID diagnosis 3) History of traumatic brain injury 4) Unlikely to comply with follow-up assessments (e.g. no fixed address, plans to move out of town) -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fahad Alam, MD
Phone
416-480-4864
Email
fahad.alam@sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Lilia Kaustov, PhD
Phone
416 480-6100
Ext
89607
Email
lilia.kaustov@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fahad Alam, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jordan Tarshis, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fahad Alam, MD
Phone
416-480-4864
Email
fahad.alam@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Jordan Tarshis, MD,FRCPC
First Name & Middle Initial & Last Name & Degree
Oskar Singer, MD,FRCPC
First Name & Middle Initial & Last Name & Degree
Stephen Choi, MD,FRCPC
First Name & Middle Initial & Last Name & Degree
Peter Giacobbe, MD
First Name & Middle Initial & Last Name & Degree
Stanley Hamstra, PhD
First Name & Middle Initial & Last Name & Degree
Adrienne Chan, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be available upon request to study PIs following publication.
IPD Sharing Time Frame
Upon publication, no limit on time.
IPD Sharing Access Criteria
Contact directly study principal investigators.

Learn more about this trial

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

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