Effect of Inhaled Hydroxy Gas on Long COVID Symptoms (LCHydroxy)

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.

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 Overview

• Status: Recruiting
• Conditions: Post-Acute COVID-19 Syndrome
• Intervention / Treatment: Device: Hydroxy gas

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shakeeb Moosavi, PhD; Phone Number: +44 (0)1865 483257; Email: smoosavi@brookes.ac.uk
• Study Contact Backup: Name: Donna Winston, PhD; Email: dwinston@brookes.ac.uk

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 0BP
      • Recruiting
      • Oxford Brookes University
      • Contact: Shakeeb Moosavi; Phone Number: 01865 483257; Email: smoosavi@brookes.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment-Placebo arm; 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; Hydroxy gas is a combination of hydrogen and oxygen together.
Other: Placebo-treatment arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exertional dyspnea	Change in total dyspnoea score from rest to peak exercise quantified using the D12 questionnaire	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)	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	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	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)

Collaborators and Investigators

• Sponsor: Oxford Brookes University
• Investigators: Principal Investigator: Shakeeb H Moosavi, PhD, Oxford Brookes University

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: December 2, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Long COVID; Long-Haul COVID; Post-Acute COVID-19 Syndrome; Long Haul COVID-19; Post-Acute Sequelae of COVID Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 231692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No