Post-Acute COVID-19 Syndrome
Conditions
Keywords
Post-Acute COVID-19 Syndrome, Long COVID, Long Haul COVID-19, Long-Haul COVID, Post-Acute Sequelae of COVID Infection
Brief 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. 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
Interventions
DEVICEHydroxy gas
Hydroxy gas is a combination of hydrogen and oxygen together.
Sponsors
Oxford Brookes University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The study is double blind. The participants will not know whether the machine they use delivers hydroxy or placebo gas. The PI and outcome assessors will also not know which machine delivers hydroxy or placebo gas to participants during the running of the study. A collaborator will be in charge of blinding for the study.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Any moderate or severe pain, breathlessness, or fatigue associated with long COVID * live within an hour's drive of the Oxford Brookes campus
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breathlessness | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exertional dyspnea | 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) | Change in total dyspnoea score from rest to peak exercise quantified using the D12 questionnaire |
| Physical capacity (muscle fatigue) | 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) | (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) |
| Psychological state and cognitive ability | 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) | (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 |
| General long COVID symptom burden | 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) | Overall % score on the long COVID Symptom Burden Questionnaire |
Countries
United Kingdom
Contacts
Primary ContactShakeeb Moosavi, PhD
Backup ContactDonna Winston, PhD
Outcome results
None listed