Hydrogen/Oxygen Mixed Gas Inhalation for Coronavirus Disease 2019 (COVID-19)

NCT04378712 | Completed DMC

• 1 other identifier: JT202005LZ
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This was a randomized, multi-center, open-label clinical trial. Eligible patients were recruited from seven hospitals in China. On the basis of standard-of-care, patients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) until discharge. Patients in control group received standard-of-care (consisting of oxygen therapy) alone until discharge.

Conditions

Covid-19; Hydrogen/Oxygen Mixed Gas; Dyspnea

Keywords

Covid-19; Hydrogen/oxygen mixed gas; Dyspnea

Outcome Measures

Primary Outcomes (3)

• The proportion of patients with improved disease severity at day 2

  The proportion of patients with improved disease severity (by at least one scale) at day 2

  from baseline to day 2

• The proportion of patients with improved disease severity at day 3

  The proportion of patients with improved disease severity (by at least one scale) at day 3

  from baseline to day 3

• The proportion of patients with improved disease severity at the day before hospital discharge

  The proportion of patients with improved disease severity (by at least one scale) at the day before hospital discharge

  up to 14 days (from baseline to the day before hospital discharge)

Secondary Outcomes (15)

• The change from baseline in oxygen saturation at day 2.

  from baseline to day 2

• The change from baseline in oxygen saturation at day 3.

  from baseline to day 3

• The change from baseline in oxygen saturation at the day before hospital discharge

  up to 14 days (from baseline to the day before hospital discharge)

• The change from baseline in dyspnea scale at day 2.

  from baseline to day 2

• The change from baseline in dyspnea scale at day 3.

  from baseline to day 3

Study Arms (2)

Intervention Group

EXPERIMENTAL

H2-O2 (66% hydrogen; 33% oxygen) inhalation. Patients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) until discharge.

Device: Hydrogen Oxygen Generator with Nebulizer; Other: Standard-of-care

Control Group

OTHER

Usual care referred to the standard-of-care (including oxygen therapy) recommended by Chinese National Health Commission.

Other: Standard-of-care

Interventions

Hydrogen Oxygen Generator with Nebulizer DEVICE

Patients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) until discharge.

Intervention Group

Standard-of-care OTHER

Standard-of-care consisted of the supportive therapies (including oxygen therapy) recommended by the Chinese National Health Commission

Control Group; Intervention 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:

• Patients with lab-confirmed Covid-19 aged 18 to 75 years.
• Had dyspnea both on hospital admission and at enrollment.
• The patients volunteered to participate in this study and signed the informed consent

You may not qualify if:

• Have other systemic diseases other than COVID-19 -- a disease that, according to the investigator's judgment, might increase the risk of developing adverse outcomes or affect the outcome measures after participation in the study.
• Women who are pregnant or breastfeeding or plan to be pregnant during the study.
• Subjects with one of the following respiratory diseases:
• Subjects in critical or unstable conditions. Critical (meeting any of the following symptoms): 1. Respiratory failure occurs and mechanical ventilation is needed; 2. Shock occurs; 3. Other organ failure, ICU monitoring and treatment is needed.
• Having immunosuppressive diseases (HIV), severe neurological disease affecting upper respiratory tract control, or other risk factors that the investigator believes can cause a significant risk of pneumonia in subjects.
• Subjects with mental disorder and cognitive impairment.
• Subjects who do not follow the study steps.
• Patients with mental retardation, poor motivation, drug abuse (including drugs and alcohol) or other disease history restricting the effectiveness of informed consent in this study.
• Use of antioxidants, including large doses of vitamin C and vitamin E.
• Subjects who are not suitable for participation in this study in the judgment of investigator.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Related Publications (5)

• Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.

  PMID: 32167524 BACKGROUND

• Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.

  PMID: 32085846 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

• Morgan SE, Vukin K, Mosakowski S, Solano P, Stanton L, Lester L, Lavani R, Hall JB, Tung A. Use of heliox delivered via high-flow nasal cannula to treat an infant with coronavirus-related respiratory infection and severe acute air-flow obstruction. Respir Care. 2014 Nov;59(11):e166-70. doi: 10.4187/respcare.02728. Epub 2014 Aug 12.

  PMID: 25118308 BACKGROUND

• Kneyber MC, van Heerde M, Markhorst DG, Plotz FB. Mechanical ventilation with heliox decreases respiratory system resistance and facilitates CO2 removal in obstructive airway disease. Intensive Care Med. 2006 Oct;32(10):1676-7. doi: 10.1007/s00134-006-0348-6. Epub 2006 Aug 23. No abstract available.

  PMID: 16927073 BACKGROUND

MeSH Terms

Conditions

COVID-19; Dyspnea

Interventions

Nebulizers and Vaporizers; Standard of Care

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; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Wei-jie Guan, PhD

  Guangzhou Institute of Respiratory Disease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of respiratory medicine, co-principal investigator

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 7, 2020
• Study Start: January 21, 2020
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Locations

CN (1)