An interventional study of Hydroxy gas in Post-Acute COVID-19 Syndrome, sponsored by Oxford Brookes University. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by Oxford Brookes University · Not applicable, Interventional, and Treatment
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
604 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 201 are open to participants now.
This study's planned enrollment of 25 is below the median of 60 across 416 interventional studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →Oxford Brookes University is the lead sponsor of 35 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Hydroxy gas
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.
Device: Hydroxy gas
Hydroxy gas is a combination of hydrogen and oxygen together.
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.
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).
Exertional dyspnea
Change in total dyspnoea score from rest to peak exercise quantified using the D12 questionnaire
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)
(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)
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
(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
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
Overall % score on the long COVID Symptom Burden Questionnaire
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)
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for May 2024, 8 months after the start.
Of 233 non-industry interventional studies with no phase under Post-Acute COVID-19 Syndrome, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 28. This study's planned 8 months is below that.
Counting every sponsor, half of 244 studies reached it within 16 months; a quarter within 7 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Post-Acute COVID-19 Syndrome →
Oxford Brookes University