Effect of Inhaled Hydroxy Gas on Long COVID Symptoms

NCT06159296 | Unknown

• 1 other identifier: 231692
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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)

  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

  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

  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)

Study Arms (2)

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.

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.

Device: Hydroxy gas

Interventions

Hydroxy gas DEVICE

Hydroxy gas is a combination of hydrogen and oxygen together.

Placebo-treatment arm; Treatment-Placebo arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any moderate or severe pain, breathlessness, or fatigue associated with long COVID
• live within an hour's drive of the Oxford Brookes campus

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford Brookes University: lead

Study Sites (1)

Oxford Brookes University

Oxford, Oxfordshire, OX3 0BP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shakeeb H Moosavi, PhD

  Oxford Brookes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shakeeb Moosavi, PhD

CONTACT

+44 (0)1865 483257; smoosavi@brookes.ac.uk

Donna Winston, PhD

CONTACT

dwinston@brookes.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Clinical Physiology

Model Details: 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.

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 6, 2023
• Study Start: September 25, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)