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

NCT04594460 | Unknown DMC

• 1 other identifier: AMS-H-03-101
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• (VO2max)

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

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

Secondary Outcomes (32)

• (VO2max)

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

• (VO2max)

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

• (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.

• (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.

• (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.

Study Arms (2)

experimental Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03 DEVICE

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.

experimental Group

OLO-1 Medical Molecular Sieve Oxygen Generator DEVICE

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ） Male or female, aged between 18 and 75 (including boundary values) at screening.
• \) Severe or critically ill patients who have been diagnosed with a novel coronavirus during hospitalization (COVID-19).
• \) 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).
• \) 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.
• \) Agrees not to participate in other drug/device studies until the study is completed.

You may not qualify if:

• \) With one of the following respiratory diseases:
• Subjects with asthma history, or cannot rule out asthma based on the diagnosis of investigator;
• Subjects with chronic obstructive pulmonary disease (COPD);
• Subjects with following respiratory diseases such as active tuberculosis, lung cancer, sarcoidosis, pulmonary hypertension, pneumothorax, uncontrolled pleural effusion through intervention, pulmonary embolism, etc.;
• Lung volume reduction: subjects have had lung volume reduction surgery, pulmonary lobectomy, or bronchoscopic lung volume reduction surgery.
• \) Subjects with pulmonary heart disease. 3) Patients who are scheduled for elective surgery during the study period, such as thoracic and abdominal major surgery.
• \) 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.
• \) Patients who have undergone surgery within 1 month prior to screening and have not fully recovered.
• \) 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.
• \) Patients with active tuberculosis infection within 12 months prior to screening.
• \) 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.
• \) Subjects with mental disorders or other conditions that are unable to cooperate effectively with the conduct of the clinical trial.
• \) Subjects intolerance to inhalation therapy. 11) Others whom the investigator or sub-investigator judged inappropriate for participation in the study.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (2)

Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, 510120, China

Location

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Related Publications (11)

• 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.

  PMID: 32141569 BACKGROUND

• Chinese Clinical Guidance for COVID-19 Penumonia Diagnosis and Treatment (7th edition)

  BACKGROUND

• 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.

  PMID: 32271601 BACKGROUND

• 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.

  PMID: 32162702 BACKGROUND

• 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.

  PMID: 32118615 BACKGROUND

• 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.

  PMID: 32381497 BACKGROUND

• 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.

  PMID: 30227423 BACKGROUND

• 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.

  PMID: 30127861 BACKGROUND

• 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.

  PMID: 29568538 BACKGROUND

• 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.

  PMID: 32642277 BACKGROUND

• 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.

  PMID: 15358703 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Nebulizers and Vaporizers

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Wei-jie Guan, PhD

  Guangzhou Institute of Respiratory Disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-jie Guan, PhD

CONTACT

+86-13826042052; battery203@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is conducted in a double-blind design with a primary unblinding, and a terminal unblinding is performed after data review, database lock, and finalization of the statistical analysis plan. Both the investigational device (AMS-H-03 Hydrogen-Oxygen Generator with Nebulizer) and the control device (OLO-1 Medical Molecular Sieve Oxygen Generator) were placed in the shell with the same appearance, with the same operating interface and only ventilation function. During the treatment, neither the investigator nor the subject would be aware of the treatment allocation The study devices will be masked by independent non-blinded personnel of the statistical company according to the corresponding operating procedures, and no specific personnel participating in the clinical operation shall be present during the process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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 targeted treatment duration will be 8 hours per day, for 12 weeks.

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 20, 2020
• Study Start: October 31, 2020
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

CN (2)