Post-Acute COVID-19 SyndromeLCHydroxyNCT06159296
Effect of Inhaled Hydroxy Gas on Long COVID Symptoms
A study testing Hydroxy gas in people with Post-Acute COVID-19 Syndrome, run by Oxford Brookes University at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to see if several weeks of self-administered, home-based, treatment involving breathing hydroxy gas (a mixture of hydrogen and oxygen) for at least 2 hours a day for 3 weeks, will relieve symptoms in patients suffering from Long COVID. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-Acute COVID-19 Syndrome
- What is being tested?
- Hydroxy gas
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Sep 2023to 31 May 2024
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any moderate or severe pain, breathlessness, or fatigue associated with long COVID
- live within an hour's drive of the Oxford Brookes campus
Who cannot join
- Pre-existing secondary diseases; tumors, mental health conditions, chronic respiratory conditions such as Chronic Obstructive Pulmonary Disease (COPD), and cardiac disease
- Previous requirement of ICU treatment due to COVID
- Acute or chronic infections or no pre-existing autoimmune diseases
Trial locations and contacts
1 site in 1 country.
Donna Winston, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Brookes University
Oxford, Oxfordshire, OX3 0BP
Shakeeb Moosavi, 01865 483257, smoosavi@brookes.ac.uk
About this study
Official title: Randomised, Placebo-controlled, Double-blind Cross-over Study to Investigate the Therapeutic Effects of an Inhaled Hydrogen/Oxygen Mixture to Improve Long COVID Symptoms
The goal of this clinical trial is to see if several weeks of self-administered, home-based, treatment involving breathing hydroxy gas (a mixture of hydrogen and oxygen) for at least 2 hours a day for 3 weeks, will relieve symptoms in patients suffering from Long COVID. The main question it aims to answer is whether inhaling hydroxy gas might be a useful treatment option to help patients with long COVID cope better and recover quicker from this condition.
Participants will wear a nasal canula (placed in their nostrils) to inhale a gas from a machine that they will be trained to use at home. In one 3-week period, the machine will deliver hydroxy gas (treatment) and in a separate 3-week period the machine will deliver normal air (placebo). The order of the treatment or placebo periods will be randomized and separated by a minimum of 3-weeks during which the participants will not use the machine ('washout' period). Neither the participant nor the investigators will know which 3-week period is the treatment and which is the placebo phase. Participants will visit the laboratory (or be tested at home) at the start and end of each 3-week period.
Read more
Testing will involve measuring physical ability (handgrip strength, how far they can walk in 6 minutes, how many times they can stand up and sit down in a minute), breathing problems (how hard they can blow out, how breathless they feel), cognitive ability (how quickly they can mark out a trail based on numbers and letters), and state of mind (mood).
The investigators hypothesize that compared to inhaling placebo, inhaling the hydroxy gas will produce greater improvement in physical ability, relieve breathing problems, and enhance cognitive ability and mood, thereby showing that it can relieve key symptoms of long COVID
- Conditions
- Post-Acute COVID-19 Syndrome
- Being tested
- Hydroxy gas
- Keywords
- Post-Acute COVID-19 Syndrome, Long COVID, Long Haul COVID-19, Long-Haul COVID, Post-Acute Sequelae of COVID Infection
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxy gasDevice
Hydroxy gas is a combination of hydrogen and oxygen together.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-Placebo arm | Other | The participants in this arm are given a machine that produces hydroxy gas in the first three weeks. In the final three weeks of the study, they will use a machine that produces a placebo gas. Receives: Device: Hydroxy gas |
| Placebo-treatment arm | Other | The participants in this arm are given a machine that produces a placebo gas in the first three weeks. In the final three weeks of the study, they will use a machine that produces hydroxy gas. Receives: Device: Hydroxy gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathlessness
Total dyspnoea score in the preceding 2 weeks, quantified from the D-12 questionnaire (% maximum score). Sample size estimate was based on this measure.
Measured: Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration).
Secondary outcomes (4)
Exertional dyspnea
Change in total dyspnoea score from rest to peak exercise quantified using the D12 questionnaire
Measured: Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)
Physical capacity (muscle fatigue)
(i) Distance walked at their own pace during the 6-minute walk test and the number of sit to stands achieved in 1 minute.
(ii) Handgrip strength measured using a hand dynamometer as the maximum squeeze (kg) sustained for 5 second (iii) Peak expiratory flow rate (PEF) achieved by blowing into a Wright's peak flow meter as hard as possible (Liters per minute)
Measured: Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)
Psychological state and cognitive ability
(i) Mood cluster scores for "sedation", "discontentment", and "tension" derived from the Bond Lader mood questionnaire (%full scale) (ii) Time taken to complete a trail marking task based on joining sequential numbers and/or letters
Measured: Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)
General long COVID symptom burden
Overall % score on the long COVID Symptom Burden Questionnaire
Measured: Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start25 Sep 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly assigned a machine that delivers either hydroxy or placebo gas in the first three weeks of the study. Those who receive placebo in the first three weeks will receive hydroxy in the last three weeks following a minimum of a 3 week washout period. Those who receive hydroxy in the first three weeks will receive placebo in the last three weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shakeeb H Moosavi, Oxford Brookes University
- Investigators
- Shakeeb H Moosavi, PhD, Principal investigator, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159296
- Sponsor's protocol ID
- 231692
- Acronym
- LCHydroxy
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Placebo-controlled, Double-blind Cross-over Study to Investigate the Therapeutic Effects of an Inhaled Hydrogen/Oxygen Mixture to Improve Long COVID Symptoms
- ClinicalTrials.gov ID
- NCT06159296
- Acronym / sponsor ID
- LCHydroxy / 231692
- Conditions
- Post-Acute COVID-19 Syndrome
- Keywords
- Post-Acute COVID-19 Syndrome, Long COVID, Long Haul COVID-19, Long-Haul COVID, Post-Acute Sequelae of COVID Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 6 Dec 2023 (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.
The goal of this clinical trial is to see if several weeks of self-administered, home-based, treatment involving breathing hydroxy gas (a mixture of hydrogen and oxygen) for at least 2 hours a day for 3 weeks, will relieve symptoms in patients suffering from Long COVID. The main question it aims to answer is whether inhaling hydroxy gas might be a useful treatment option to help patients with long COVID cope better and recover quicker from this condition.
Participants will wear a nasal canula (placed in their nostrils) to inhale a gas from a machine that they will be trained to use at home. In one 3-week period, the machine will deliver hydroxy gas (treatment) and in a separate 3-week period the machine will deliver normal air (placebo). The order of the treatment or placebo periods will be randomized and separated by a minimum of 3-weeks during which the participants will not use the machine ('washout' period). Neither the participant nor the investigators will know which 3-week period is the treatment and which is the placebo phase. Participants will visit the laboratory (or be tested at home) at the start and end of each 3-week period.
Testing will involve measuring physical ability (handgrip strength, how far they can walk in 6 minutes, how many times they can stand up and sit down in a minute), breathing problems (how hard they can blow out, how breathless they feel), cognitive ability (how quickly they can mark out a trail based on numbers and letters), and state of mind (mood).
The investigators hypothesize that compared to inhaling placebo, inhaling the hydroxy gas will produce greater improvement in physical ability, relieve breathing problems, and enhance cognitive ability and mood, thereby showing that it can relieve key symptoms of long COVID
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned a machine that delivers either hydroxy or placebo gas in the first three weeks of the study. Those who receive placebo in the first three weeks will receive hydroxy in the last three weeks following a minimum of a 3 week washout period. Those who receive hydroxy in the first three weeks will receive placebo in the last three weeks.
| Arm | Type | Receives |
|---|---|---|
| Treatment-Placebo arm | Other | Device: Hydroxy gasThe participants in this arm are given a machine that produces hydroxy gas in the first three weeks. In the final three weeks of the study, they will use a machine that produces a placebo gas. |
| Placebo-treatment arm | Other | Device: Hydroxy gasThe participants in this arm are given a machine that produces a placebo gas in the first three weeks. In the final three weeks of the study, they will use a machine that produces hydroxy gas. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any moderate or severe pain, breathlessness, or fatigue associated with long COVID
- live within an hour's drive of the Oxford Brookes campus
Key exclusion criteria (3 listed)
- Pre-existing secondary diseases; tumors, mental health conditions, chronic respiratory conditions such as Chronic Obstructive Pulmonary Disease (COPD), and cardiac disease
- Previous requirement of ICU treatment due to COVID
- Acute or chronic infections or no pre-existing autoimmune diseases
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 |
|---|---|---|
| Hydroxy gasHydroxy gas is a combination of hydrogen and oxygen together. | Device | Placebo-treatment arm, Treatment-Placebo arm |
Primary outcome
Breathlessness
Time frame: Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration).
Total dyspnoea score in the preceding 2 weeks, quantified from the D-12 questionnaire (% maximum score). Sample size estimate was based on this measure.
4 secondary outcomes
Exertional dyspnea
Time frame: Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)
Physical capacity (muscle fatigue)
Time frame: Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)
Psychological state and cognitive ability
Time frame: Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)
General long COVID symptom burden
Time frame: Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Donna Winston, PhD contact
Shakeeb H Moosavi, PhD principal investigator
Oxford Brookes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxy gas in people with Post-Acute COVID-19 Syndrome, run by Oxford Brookes University at 1 site in United Kingdom.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Dec 2023. 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 United Kingdom. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shakeeb Moosavi, PhD (+44 (0)1865 483257, smoosavi@brookes.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathlessness (time frame: Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration).). 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 6 Dec 2023.