Clinical trial NCT06159296: Effect of Inhaled Hydroxy Gas on Long COVID Symptoms
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Oxford Brookes University
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Breathlessness
timeFrame: 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:
measure: Exertional dyspnea
timeFrame: 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)
measure: Physical capacity (muscle fatigue)
timeFrame: 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)
measure: Psychological state and cognitive ability
timeFrame: 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)
measure: General long COVID symptom burden
timeFrame: 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)
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Brookes University
state: Oxfordshire
Study officials:
affiliation: Oxford Brookes University
name: Shakeeb H Moosavi, PhD
role: PRINCIPAL_INVESTIGATOR
References: