Post COVID-19 ConditionPhase 1Hi-OXSRNCT06379620
Pilot Open Label Use of the Hi-OXSR for the Treatment of Post COVID-19 Cognitive Dysfunction
A Phase 1 study testing Hi-OxSR Sequential Rebreathing mask (oxygen concentrator) in people with Post COVID-19 Condition, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
During the worldwide COVID-19 pandemic a large number patients reported different functional complaints one month or later after recovery from the acute infection. This entity had a number of names including "long-COVID" or "post COVID condition". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post COVID-19 Condition
- What is being tested?
- Hi-OxSR Sequential Rebreathing mask (oxygen concentrator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 29 Nov 2022to 4 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent.
- Previously diagnosed with cognitive dysfunction following recovery from COVID.
- Not pregnant at time of study.
- Oxygen saturation on room air ≥92% at screening.
- Willing and able to comply with the treatment schedule and procedures.
Who cannot join
- History of cognitive dysfunction prior to COVID infection
- Hospitalization for the treatment of COVID
- Participating in another investigational trial or the use of an investigational drug within 30 days of screening
- For individuals of childbearing potential:
- positive pregnancy test at screening or lactating or unwilling to practice a medically acceptable form of contraception from screening to Day 14 (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent)
- History of pulmonary hypertension
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- History of narcolepsy
- Moderate to severe COPD
- Interstitial Pulmonary Fibrosis
- End-tidal PCO2 >55 mmHg during training treatment
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Open Label Use of the Hi-OXSR to Increase PaCO2 for the Treatment of Post COVID-19 Cognitive Dysfunction
During the worldwide COVID-19 pandemic a large number patients reported different functional complaints one month or later after recovery from the acute infection. This entity had a number of names including "long-COVID" or "post COVID condition". Long-COVID is on the rise and no effective treatment exists yet to improve cognitive function. Recent research has shown that people with even mild COVID had a greater decline in executive function, notably in their ability to perform complex tasks. What drives post-COVID cognitive changes is still a mystery and there are no effective treatments available. One hypothesis is that there is persistent immune activation resulting in reduction in cerebral blood flow. There is evidence that increased CO2 may decrease inflammation, and decreased CO2 may increase inflammation.
Objectives: The primary objective of this pilot study is to assess the safety and tolerability of the use of Hi-OX sequential rebreathing for the treatment of post-COVID cognitive dysfunction. The secondary objective is to identify the effects of the use of the Hi-OX rebreathing treatment in changing post-COVID cognitive dysfunction.
- Conditions
- Post COVID-19 Condition
- Being tested
- Hi-OxSR Sequential Rebreathing mask (oxygen concentrator)
- Keywords
- cognitive dysfunction, post-COVID condition, long COVID, SARS-CoV2
- Medical subject headings
- Cognitive Dysfunction, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hi-OxSR Sequential Rebreathing mask (oxygen concentrator)Device
Subjects will self-administer oxygen gas at 1to 3LPM via a Hi-OxSR Sequential Rebreathing mask (oxygen concentrator), twice a day for 30 minutes with ventilation supplemented by the subject's rebreathed exhaled air. Total treatment is for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Hi-OXSR group | Experimental | Oxygen gas at 1 to 3LPM via a Hi-OxSR Sequential Rebreathing mask (oxygen concentrator), twice a day for 30 minutes with increased inspired CO2 concentration produced by having the subject rebreathe some of their exhaled air. Total treatment is for 14 days. Receives: Device: Hi-OxSR Sequential Rebreathing mask (oxygen concentrator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of use of Hi-OX sequential rebreathing device
Any unanticipated adverse events reporting
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start29 Nov 2022
- Primary completion4 Mar 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID-19 ConditionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open label, pilot treatment study. Screening data will be reviewed to determine subject eligibility. Upon successful completion of all screening procedures, subject will be considered eligible for enrollment. The subject will self-administer oxygen gas at 1to 3LPM via a Hi-OxSR Sequential Rebreathing mask, twice a day for 30 minutes with ventilation supplemented by the subject's rebreathed exhaled air. Total treatment is for 14 days. Subjects will be asked to return to the clinic for additional evaluations on Days 15 and 45.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Cheung, Md, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379620
- Sponsor's protocol ID
- 22-5544
- Acronym
- Hi-OXSR
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Open Label Use of the Hi-OXSR to Increase PaCO2 for the Treatment of Post COVID-19 Cognitive Dysfunction
- ClinicalTrials.gov ID
- NCT06379620
- Acronym / sponsor ID
- Hi-OXSR / 22-5544
- Conditions
- Post COVID-19 Condition
- Keywords
- cognitive dysfunction, post-COVID condition, long COVID, SARS-CoV2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During the worldwide COVID-19 pandemic a large number patients reported different functional complaints one month or later after recovery from the acute infection. This entity had a number of names including "long-COVID" or "post COVID condition". Long-COVID is on the rise and no effective treatment exists yet to improve cognitive function. Recent research has shown that people with even mild COVID had a greater decline in executive function, notably in their ability to perform complex tasks. What drives post-COVID cognitive changes is still a mystery and there are no effective treatments available. One hypothesis is that there is persistent immune activation resulting in reduction in cerebral blood flow. There is evidence that increased CO2 may decrease inflammation, and decreased CO2 may increase inflammation.
Objectives: The primary objective of this pilot study is to assess the safety and tolerability of the use of Hi-OX sequential rebreathing for the treatment of post-COVID cognitive dysfunction. The secondary objective is to identify the effects of the use of the Hi-OX rebreathing treatment in changing post-COVID cognitive dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open label, pilot treatment study. Screening data will be reviewed to determine subject eligibility. Upon successful completion of all screening procedures, subject will be considered eligible for enrollment. The subject will self-administer oxygen gas at 1to 3LPM via a Hi-OxSR Sequential Rebreathing mask, twice a day for 30 minutes with ventilation supplemented by the subject's rebreathed exhaled air. Total treatment is for 14 days. Subjects will be asked to return to the clinic for additional evaluations on Days 15 and 45.
| Arm | Type | Receives |
|---|---|---|
| Hi-OXSR group | Experimental | Device: Hi-OxSR Sequential Rebreathing mask (oxygen concentrator)Oxygen gas at 1 to 3LPM via a Hi-OxSR Sequential Rebreathing mask (oxygen concentrator), twice a day for 30 minutes with increased inspired CO2 concentration produced by having the subject rebreathe some of their exhaled air. Total treatment is for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to provide written informed consent.
- Previously diagnosed with cognitive dysfunction following recovery from COVID.
- Not pregnant at time of study.
- Oxygen saturation on room air ≥92% at screening.
- Willing and able to comply with the treatment schedule and procedures.
Key exclusion criteria (11 listed)
- History of cognitive dysfunction prior to COVID infection
- Hospitalization for the treatment of COVID
- Participating in another investigational trial or the use of an investigational drug within 30 days of screening
- For individuals of childbearing potential:
- positive pregnancy test at screening or lactating or unwilling to practice a medically acceptable form of contraception from screening to Day 14 (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hi-OxSR Sequential Rebreathing mask (oxygen concentrator)Subjects will self-administer oxygen gas at 1to 3LPM via a Hi-OxSR Sequential Rebreathing mask (oxygen concentrator), twice a day for 30 minutes with ventilation supplemented by the subject's rebreathed exhaled air. Total treatment is for 14 days | Device | Hi-OXSR group |
Primary outcome
Safety of use of Hi-OX sequential rebreathing device
Time frame: 45 days
Any unanticipated adverse events reporting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Cheung, Md, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hi-OxSR Sequential Rebreathing mask (oxygen concentrator) in people with Post COVID-19 Condition, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of use of Hi-OX sequential rebreathing device (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.