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Status unknownNCT04594460Updated Oct 22, 2020

Hydrogen-oxygen Gas Mixture Inhalation in Patients With Convalescent Coronavirus Disease 2019 (COVID-19)

An interventional study of Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03 and OLO-1 Medical Molecular Sieve Oxygen Generator in Covid19, Hydrogen-oxygen Gas and AMS-H-03, sponsored by Guangzhou Institute of Respiratory Disease. Status unknown at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-10-22.

Sponsored by Guangzhou Institute of Respiratory Disease · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study is a multicenter, randomized, open, parallel-controlled study. Qualified subjects will randomly be assigned to the experimental arm or the control arm according to the ratio of 1:1, with age (> 60 years or ≤ 60 years), smoking status (yes/no) and forced expiratory volume in one second/prediction (FEV1 %pred > 60% or ≤ 60%) as the random stratification factors.

Read the detailed description

Subjects in the experimental arm and the control arm will receive hydrogen-oxygen mixed gas inhalation (Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03, output: 3 L/min (hydrogen concentration: 66.7%, oxygen concentration: 33.3%)) and oxygen inhalation (OLO-1 Medical Molecular Sieve Oxygen Generator, output: 3 L/min (oxygen concentration: 33.3%), Shanghai Ouliang Medical Devices Co., Ltd.), respectively; the treatment duration will not be less than 8 hours per day, for 12 weeks.

Subjects in the experimental arm and the control arm will also receive other medications (excluding antiviral drugs) by the investigator as clinically indicated. Six visits are required for each subject in this study, including Visit 1 (D-7\~-1), Visit 2 (D1), Visit 3 (D14±3d), Visit 4 (D28±3d), Visit 5 (D56±7d), Visit 6 (D84±7d).

02

Conditions studied

  • Covid19
  • Hydrogen-oxygen Gas
  • AMS-H-03

Browse trials for

Keywords

  • Covid19
  • Hydrogen-oxygen Gas
  • AMS-H-03
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 198 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Guangzhou Institute of Respiratory Disease is the lead sponsor of 96 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 1） Male or female, aged between 18 and 75 (including boundary values) at screening.

    1. Severe or critically ill patients who have been diagnosed with a novel coronavirus during hospitalization (COVID-19).
    1. After treatment, the patients have met the discharge criteria of "COVID-19 Diagnosis and Treatment Guideline", and the time from hospital discharge is at least 1 month at the time of enrollment. The clinical symptoms of the subjects did not worsen significantly as compared with that at the time of discharge, and the COVID-19 nucleic acid test results are negative for at least 2 consecutive times (one of which could be the nucleic acid test before discharge).
    1. Forced vital capacity/per predicted (FVC% pred) ≥ 50%. 5) 50% ≤ FEV1 %pred ≤80%。 6) Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. Understands and agrees to comply with planned study procedures.
    1. Agrees not to participate in other drug/device studies until the study is completed.

Exclusion criteria

Exclusion Criteria:

    1. With one of the following respiratory diseases:

      1. Subjects with asthma history, or cannot rule out asthma based on the diagnosis of investigator;
      2. Subjects with chronic obstructive pulmonary disease (COPD);
      3. Subjects with following respiratory diseases such as active tuberculosis, lung cancer, sarcoidosis, pulmonary hypertension, pneumothorax, uncontrolled pleural effusion through intervention, pulmonary embolism, etc.;

      4. Lung volume reduction: subjects have had lung volume reduction surgery, pulmonary lobectomy, or bronchoscopic lung volume reduction surgery.

        1. Subjects with pulmonary heart disease. 3) Patients who are scheduled for elective surgery during the study period, such as thoracic and abdominal major surgery.
        1. Subjects, judged by investigators, with previous or current diseases, which may affect the participation in this study or the outcome of this study: such as cancer, diseases of heart, liver, kidney, hematopoietic system and other vital organs or systems, etc.
        1. Patients who have undergone surgery within 1 month prior to screening and have not fully recovered.
        1. Occurrence of congestive heart failure, uncontrolled or unstable angina or myocardial infarction, cerebrovascular accident, or history of pulmonary embolism within 6 months prior to screening.
        1. Patients with active tuberculosis infection within 12 months prior to screening.
        1. Pregnancy or lactating women, or women of childbearing potential not agree to either abstinence or use at least one primary form of contraception from the time of screening till the study is completed.
        1. Subjects with mental disorders or other conditions that are unable to cooperate effectively with the conduct of the clinical trial.
        1. Subjects intolerance to inhalation therapy. 11) Others whom the investigator or sub-investigator judged inappropriate for participation in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
198 participants (estimated)

Study arms

  • Experimental
    experimental Group

    the experimental arm will receive hydrogen-oxygen mixed gas inhalation (Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03, output: 3 L/min (hydrogen concentration: 66.7%, oxygen concentration: 33.3%)) ,the treatment duration will be 8 hours per day, for 12 weeks.

    Device: Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03

  • Active comparator
    Control Group

    the control arm will receive oxygen inhalation (OLO-1 Medical Molecular Sieve Oxygen Generator, output: 3 L/min (oxygen concentration: 33.3%), Shanghai Ouliang Medical Devices Co., Ltd.)the treatment duration will be 8 hours per day, for 12 weeks.

    Device: OLO-1 Medical Molecular Sieve Oxygen Generator

Interventions

  • DeviceHydrogen-Oxygen Generator with Nebulizer, AMS-H-03

    the experimental arm will receive hydrogen-oxygen mixed gas inhalation (Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03, output: 3 L/min (hydrogen concentration: 66.7%, oxygen concentration: 33.3%)) ,the treatment duration will be 8 hours per day, for 12 weeks.

  • DeviceOLO-1 Medical Molecular Sieve Oxygen Generator

    the control arm will receive oxygen inhalation (OLO-1 Medical Molecular Sieve Oxygen Generator, output: 3 L/min (oxygen concentration: 33.3%), Shanghai Ouliang Medical Devices Co., Ltd.)the treatment duration will be 8 hours per day, for 12 weeks.

06

What researchers measure

Primary outcomes

  1. (VO2max)

    The change from baseline in maximum oxygen consumption (VO2max) at maximum exercise load at Week 12 of treatment.

    Time frame: The change from baseline in maximum oxygen consumption (VO2max) at maximum exercise load at Week 12 of treatment.

Secondary outcomes

  1. (VO2max)

    The change from baseline in maximum oxygen consumption (VO2max) at maximum exercise load at Week 4 of treatment.

    Time frame: The change from baseline in maximum oxygen consumption (VO2max) at maximum exercise load at Week 4 of treatment.

  2. (VO2max)

    The change from baseline in maximum oxygen consumption (VO2max) at maximum exercise load at Week 8 of treatment.

    Time frame: The change from baseline in maximum oxygen consumption (VO2max) at maximum exercise load at Week 8 of treatment.

  3. (VE /VCO2)

    Differences in the change from baseline in ventilatory equivalent for carbon dioxide (VE /VCO2) at maximum exercise load at Week 4 of treatment.

    Time frame: Differences in the change from baseline in ventilatory equivalent for carbon dioxide (VE /VCO2) at maximum exercise load at Week 4 of treatment.

  4. (VE /VCO2)

    Differences in the change from baseline in ventilatory equivalent for carbon dioxide (VE /VCO2) at maximum exercise load at Week 8 of treatment.

    Time frame: Differences in the change from baseline in ventilatory equivalent for carbon dioxide (VE /VCO2) at maximum exercise load at Week 8 of treatment.

  5. (VE /VCO2)

    Differences in the change from baseline in ventilatory equivalent for carbon dioxide (VE /VCO2) at maximum exercise load at Week 12 of treatment.

    Time frame: Differences in the change from baseline in ventilatory equivalent for carbon dioxide (VE /VCO2) at maximum exercise load at Week 12 of treatment.

  6. (VE /VO2)

    Differences in the change from baseline in ventilatory equivalent for oxygen (VE /VO2) at maximum exercise load at Week 4 of treatment.

    Time frame: Differences in the change from baseline in ventilatory equivalent for oxygen (VE /VO2) at maximum exercise load at Week 4 of treatment.

  7. (VE /VO2)

    Differences in the change from baseline in ventilatory equivalent for oxygen (VE /VO2) at maximum exercise load at Week 8 of treatment.

    Time frame: Differences in the change from baseline in ventilatory equivalent for oxygen (VE /VO2) at maximum exercise load at Week 8 of treatment.

  8. (VE /VO2)

    Differences in the change from baseline in ventilatory equivalent for oxygen (VE /VO2) at maximum exercise load at Week 12 of treatment.

    Time frame: Differences in the change from baseline in ventilatory equivalent for oxygen (VE /VO2) at maximum exercise load at Week 12 of treatment.

  9. (VO2 /HR)

    Differences in the change from baseline in oxygen pulse (VO2 /HR) at maximum exercise load at Week 4 treatment.

    Time frame: Differences in the change from baseline in oxygen pulse (VO2 /HR) at maximum exercise load at Week 4 of treatment.

  10. (VO2 /HR)

    Differences in the change from baseline in oxygen pulse (VO2 /HR) at maximum exercise load at Week 8 of treatment.

    Time frame: Differences in the change from baseline in oxygen pulse (VO2 /HR) at maximum exercise load at Week 8 of treatment.

  11. (VO2 /HR)

    Differences in the change from baseline in oxygen pulse (VO2 /HR) at maximum exercise load at Week 12 of treatment.

    Time frame: Differences in the change from baseline in oxygen pulse (VO2 /HR) at maximum exercise load at Week 12 of treatment.

  12. (P (A-a) O2)

    The change from baseline in the alveolar-arterial oxygen tension gradient (P (A-a) O2) at maximum exercise load at Week 4 of treatment.

    Time frame: The change from baseline in the alveolar-arterial oxygen tension gradient (P (A-a) O2) at maximum exercise load at Week 4 of treatment.

  13. (P (A-a) O2)

    The change from baseline in the alveolar-arterial oxygen tension gradient (P (A-a) O2) at maximum exercise load at Week 8 of treatment.

    Time frame: The change from baseline in the alveolar-arterial oxygen tension gradient (P (A-a) O2) at maximum exercise load at Week 8 of treatment.

  14. (P (A-a) O2)

    The change from baseline in the alveolar-arterial oxygen tension gradient (P (A-a) O2) at maximum exercise load at Week 12 of treatment.

    Time frame: The change from baseline in the alveolar-arterial oxygen tension gradient (P (A-a) O2) at maximum exercise load at Week 12 of treatment.

  15. (P (a-et) CO2)

    The change from baseline in the arterial-to-end-tidal CO2 difference (P (a-et) CO2) at maximum exercise load at Week 4 of treatment.

    Time frame: The change from baseline in the arterial-to-end-tidal CO2 difference (P (a-et) CO2) at maximum exercise load at Week 4 of treatment.

  16. (P (a-et) CO2)

    The change from baseline in the arterial-to-end-tidal CO2 difference (P (a-et) CO2) at maximum exercise load at Week 8 of treatment.

    Time frame: The change from baseline in the arterial-to-end-tidal CO2 difference (P (a-et) CO2) at maximum exercise load at Week 8 of treatment.

  17. (P (a-et) CO2)

    The change from baseline in the arterial-to-end-tidal CO2 difference (P (a-et) CO2) at maximum exercise load at Week 12 of treatment.

    Time frame: The change from baseline in the arterial-to-end-tidal CO2 difference (P (a-et) CO2) at maximum exercise load at Week 12 of treatment.

  18. maximum exercise power

    The change from baseline in maximum exercise power at Week 4 of treatment.

    Time frame: The change from baseline in maximum exercise power at Week 4 of treatment.

  19. maximum exercise power

    The change from baseline in maximum exercise power at Week 8 of treatment.

    Time frame: The change from baseline in maximum exercise power at Week 8 of treatment.

  20. maximum exercise power

    The change from baseline in maximum exercise power at Week 12 of treatment.

    Time frame: The change from baseline in maximum exercise power at Week 12 of treatment.

  21. RER

    The change from baseline in respiratory quotient (RER) at maximum exercise load at Week 4 of treatment.

    Time frame: The change from baseline in respiratory quotient (RER) at maximum exercise load at Week 4 of treatment.

  22. RER

    The change from baseline in respiratory quotient (RER) at maximum exercise load at Week 8 of treatment.

    Time frame: The change from baseline in respiratory quotient (RER) at maximum exercise load at Week 8 of treatment.

  23. RER

    The change from baseline in respiratory quotient (RER) at maximum exercise load at Week 12 of treatment.

    Time frame: The change from baseline in respiratory quotient (RER) at maximum exercise load at Week 12 of treatment.

  24. The change from baseline in total exercise duration at maximum exercise load at Week 4 of treatment.

    The change from baseline in total exercise duration at maximum exercise load at Week 4 of treatment.

    Time frame: The change from baseline in total exercise duration at maximum exercise load at Week 4 of treatment.

  25. The change from baseline in total exercise duration at maximum exercise load at Week 8 of treatment.

    The change from baseline in total exercise duration at maximum exercise load at Week 8 of treatment.

    Time frame: The change from baseline in total exercise duration at maximum exercise load at Week 8 of treatment.

  26. The change from baseline in total exercise duration at maximum exercise load at Week 12 of treatment.

    The change from baseline in total exercise duration at maximum exercise load at Week 12 of treatment.

    Time frame: The change from baseline in total exercise duration at maximum exercise load at Week 12 of treatment.

  27. (SpO2)

    The change from baseline in fingertip oxygen saturation (SpO2) at rest and without oxygen inhalation at Week 4 of treatment.

    Time frame: The change from baseline in fingertip oxygen saturation (SpO2) at rest and without oxygen inhalation at Week 4 of treatment.

  28. (SpO2)

    The change from baseline in fingertip oxygen saturation (SpO2) at rest and without oxygen inhalation at Week 8 of treatment.

    Time frame: The change from baseline in fingertip oxygen saturation (SpO2) at rest and without oxygen inhalation at Week 8 of treatment.

  29. (SpO2)

    The change from baseline in fingertip oxygen saturation (SpO2) at rest and without oxygen inhalation at Week 12 of treatment.

    Time frame: The change from baseline in fingertip oxygen saturation (SpO2) at rest and without oxygen inhalation at Week 12 of treatment.

  30. (mMRC)

    The change from baseline in the modified Medical Research Council (mMRC) Dyspnea Scale score at week 4 of treatment.

    Time frame: The change from baseline in the modified Medical Research Council (mMRC) Dyspnea Scale score at week 4 of treatment.

  31. (mMRC)

    The change from baseline in the modified Medical Research Council (mMRC) Dyspnea Scale score at week 8 of treatment.

    Time frame: The change from baseline in the modified Medical Research Council (mMRC) Dyspnea Scale score at week 8 of treatment.

  32. (mMRC)

    The change from baseline in the modified Medical Research Council (mMRC) Dyspnea Scale score at week 12 of treatment.

    Time frame: The change from baseline in the modified Medical Research Council (mMRC) Dyspnea Scale score at week 12 of treatment.

07

Study locations

2 sites
  • Guangzhou Institute of Respiratory Disease
    Guangzhou, Guangdong 510120, China
  • First Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong, China
08

References and documents

Publications

  • Kannan S, Shaik Syed Ali P, Sheeza A, Hemalatha K. COVID-19 (Novel Coronavirus 2019) - recent trends. Eur Rev Med Pharmacol Sci. 2020 Feb;24(4):2006-2011. doi: 10.26355/eurrev_202002_20378. PubMed 32141569 ↗
  • Chinese Clinical Guidance for COVID-19 Penumonia Diagnosis and Treatment (7th edition)
  • Huang X, Wei F, Hu L, Wen L, Chen K. Epidemiology and Clinical Characteristics of COVID-19. Arch Iran Med. 2020 Apr 1;23(4):268-271. doi: 10.34172/aim.2020.09. PubMed 32271601 ↗
  • Li LQ, Huang T, Wang YQ, Wang ZP, Liang Y, Huang TB, Zhang HY, Sun W, Wang Y. COVID-19 patients' clinical characteristics, discharge rate, and fatality rate of meta-analysis. J Med Virol. 2020 Jun;92(6):577-583. doi: 10.1002/jmv.25757. Epub 2020 Mar 23. PubMed 32162702 ↗
  • Li K, Wu J, Wu F, Guo D, Chen L, Fang Z, Li C. The Clinical and Chest CT Features Associated With Severe and Critical COVID-19 Pneumonia. Invest Radiol. 2020 Jun;55(6):327-331. doi: 10.1097/RLI.0000000000000672. PubMed 32118615 ↗
  • Mo X, Jian W, Su Z, Chen M, Peng H, Peng P, Lei C, Chen R, Zhong N, Li S. Abnormal pulmonary function in COVID-19 patients at time of hospital discharge. Eur Respir J. 2020 Jun 18;55(6):2001217. doi: 10.1183/13993003.01217-2020. Print 2020 Jun. PubMed 32381497 ↗
  • Zhou ZQ, Zhong CH, Su ZQ, Li XY, Chen Y, Chen XB, Tang CL, Zhou LQ, Li SY. Breathing Hydrogen-Oxygen Mixture Decreases Inspiratory Effort in Patients with Tracheal Stenosis. Respiration. 2019;97(1):42-51. doi: 10.1159/000492031. Epub 2018 Sep 18. PubMed 30227423 ↗
  • Yang Y, Zhu Y, Xi X. Anti-inflammatory and antitumor action of hydrogen via reactive oxygen species. Oncol Lett. 2018 Sep;16(3):2771-2776. doi: 10.3892/ol.2018.9023. Epub 2018 Jun 26. PubMed 30127861 ↗
  • Zhang N, Deng C, Zhang X, Zhang J, Bai C. Inhalation of hydrogen gas attenuates airway inflammation and oxidative stress in allergic asthmatic mice. Asthma Res Pract. 2018 Mar 15;4:3. doi: 10.1186/s40733-018-0040-y. eCollection 2018. PubMed 29568538 ↗
  • Guan WJ, Wei CH, Chen AL, Sun XC, Guo GY, Zou X, Shi JD, Lai PZ, Zheng ZG, Zhong NS. Hydrogen/oxygen mixed gas inhalation improves disease severity and dyspnea in patients with Coronavirus disease 2019 in a recent multicenter, open-label clinical trial. J Thorac Dis. 2020 Jun;12(6):3448-3452. doi: 10.21037/jtd-2020-057. No abstract available. Erratum In: J Thorac Dis. 2020 Aug;12(8):4591-4592. doi: 10.21037/jtd-2020-062. PubMed 32642277 ↗
  • Ong KC, Ng AW, Lee LS, Kaw G, Kwek SK, Leow MK, Earnest A. Pulmonary function and exercise capacity in survivors of severe acute respiratory syndrome. Eur Respir J. 2004 Sep;24(3):436-42. doi: 10.1183/09031936.04.00007104. PubMed 15358703 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04594460
Lead sponsor
Guangzhou Institute of Respiratory Disease
Responsible party
Weijie Guan (Doctor, Guangzhou Institute of Respiratory Disease) — Principal investigator
First posted
Oct 20, 2020
Start date
Oct 31, 2020 (estimated)
Primary completion
Oct 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Oct 22, 2020

Study contacts

Wei-jie Guan, PhD
Contact
battery203@163.com
+86-13826042052
Wei-jie Guan, PhD
principal investigator · Guangzhou Institute of Respiratory Disease

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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