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

Primary Purpose

Covid-19, Hydrogen/Oxygen Mixed Gas, Dyspnea

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hydrogen Oxygen Generator with Nebulizer
Standard-of-care
Sponsored by
Guangzhou Institute of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19 focused on measuring Covid-19, Hydrogen/oxygen mixed gas, Dyspnea

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • First Affiliated Hospital of Guangzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

The change from baseline in oxygen saturation at day 2.
The change from baseline in oxygen saturation at day 2.
The change from baseline in oxygen saturation at day 3.
The change from baseline in oxygen saturation at day 3.
The change from baseline in oxygen saturation at the day before hospital discharge
The change from baseline in oxygen saturation at the day before hospital discharge.
The change from baseline in dyspnea scale at day 2.
The change from baseline in dyspnea scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 2.
The change from baseline in dyspnea scale at day 3.
The change from baseline in dyspnea scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 3.
The change from baseline in dyspnea scale at the day before hospital discharge.
The change from baseline in dyspnea scale (ranging from 0-4, with higher scores indicating severer outcomes) at the day before hospital discharge.
The change from baseline in cough scale at day 2
The change from baseline in cough scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 2
The change from baseline in cough scale at day 3
The change from baseline in cough scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 3
The change from baseline in cough scale at the day before hospital discharge
The change from baseline in cough scale (ranging from 0-4, with higher scores indicating severer outcomes) at the day before hospital discharge
The change from baseline in chest pain scale at day 2.
The change from baseline in chest pain scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 2.
The change from baseline in chest pain scale at day 3.
The change from baseline in chest pain scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 3.
The change from baseline in chest pain scale at the day before hospital discharge.
The change from baseline in chest pain scale (ranging from 0-4, with higher scores indicating severer outcomes) at the day before hospital discharge.
The change from baseline in chest distress scale at day 2.
The change from baseline in chest distress scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 2.
The change from baseline in chest distress scale at day 3.
The change from baseline in chest distress scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 3.
The change from baseline in chest distress scale at the day before hospital discharge.
The change from baseline in chest distress scale (ranging from 0-4, with higher scores indicating severer outcomes) at the day before hospital discharge.

Full Information

First Posted
April 29, 2020
Last Updated
May 13, 2020
Sponsor
Guangzhou Institute of Respiratory Disease
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1. Study Identification

Unique Protocol Identification Number
NCT04378712
Brief Title
Hydrogen/Oxygen Mixed Gas Inhalation for Coronavirus Disease 2019 (COVID-19)
Official Title
Effects of Hydrogen/Oxygen Mixed Gas Inhalation for Patients With Coronavirus Disease 2019 (COVID-19) Who Had Dyspnea: A Multicenter, Open-label Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
March 23, 2020 (Actual)
Study Completion Date
March 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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. Clinical assessments included the five-category ordinal scale, four-category ordinary scale of dyspnea, coughing, chest distress and chest pain (0: None; 1: Mild; 2: Moderate; 3: Severe; 4: Very severe) and adverse events, performed on admission, at enrollment, at day 2 and 3 after randomization, and the day before discharge. The primary endpoint was the proportion of patients with improved disease severity (by at least one scale). Secondary endpoints comprised the change from baseline in oxygen saturation and symptom scales.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19, Hydrogen/Oxygen Mixed Gas, Dyspnea
Keywords
Covid-19, Hydrogen/oxygen mixed gas, Dyspnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
Usual care referred to the standard-of-care (including oxygen therapy) recommended by Chinese National Health Commission.
Intervention Type
Device
Intervention Name(s)
Hydrogen Oxygen Generator with Nebulizer
Intervention Description
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 Type
Other
Intervention Name(s)
Standard-of-care
Intervention Description
Standard-of-care consisted of the supportive therapies (including oxygen therapy) recommended by the Chinese National Health Commission
Primary Outcome Measure Information:
Title
The proportion of patients with improved disease severity at day 2
Description
The proportion of patients with improved disease severity (by at least one scale) at day 2
Time Frame
from baseline to day 2
Title
The proportion of patients with improved disease severity at day 3
Description
The proportion of patients with improved disease severity (by at least one scale) at day 3
Time Frame
from baseline to day 3
Title
The proportion of patients with improved disease severity at the day before hospital discharge
Description
The proportion of patients with improved disease severity (by at least one scale) at the day before hospital discharge
Time Frame
up to 14 days (from baseline to the day before hospital discharge)
Secondary Outcome Measure Information:
Title
The change from baseline in oxygen saturation at day 2.
Description
The change from baseline in oxygen saturation at day 2.
Time Frame
from baseline to day 2
Title
The change from baseline in oxygen saturation at day 3.
Description
The change from baseline in oxygen saturation at day 3.
Time Frame
from baseline to day 3
Title
The change from baseline in oxygen saturation at the day before hospital discharge
Description
The change from baseline in oxygen saturation at the day before hospital discharge.
Time Frame
up to 14 days (from baseline to the day before hospital discharge)
Title
The change from baseline in dyspnea scale at day 2.
Description
The change from baseline in dyspnea scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 2.
Time Frame
from baseline to day 2
Title
The change from baseline in dyspnea scale at day 3.
Description
The change from baseline in dyspnea scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 3.
Time Frame
from baseline to day 3
Title
The change from baseline in dyspnea scale at the day before hospital discharge.
Description
The change from baseline in dyspnea scale (ranging from 0-4, with higher scores indicating severer outcomes) at the day before hospital discharge.
Time Frame
up to 14 days (from baseline to the day before hospital discharge)
Title
The change from baseline in cough scale at day 2
Description
The change from baseline in cough scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 2
Time Frame
from baseline to day 2
Title
The change from baseline in cough scale at day 3
Description
The change from baseline in cough scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 3
Time Frame
from baseline to day 3
Title
The change from baseline in cough scale at the day before hospital discharge
Description
The change from baseline in cough scale (ranging from 0-4, with higher scores indicating severer outcomes) at the day before hospital discharge
Time Frame
up to 14 days (from baseline to the day before hospital discharge)
Title
The change from baseline in chest pain scale at day 2.
Description
The change from baseline in chest pain scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 2.
Time Frame
from baseline to day 2
Title
The change from baseline in chest pain scale at day 3.
Description
The change from baseline in chest pain scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 3.
Time Frame
from baseline to day 3
Title
The change from baseline in chest pain scale at the day before hospital discharge.
Description
The change from baseline in chest pain scale (ranging from 0-4, with higher scores indicating severer outcomes) at the day before hospital discharge.
Time Frame
up to 14 days (from baseline to the day before hospital discharge)
Title
The change from baseline in chest distress scale at day 2.
Description
The change from baseline in chest distress scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 2.
Time Frame
from baseline to day 2
Title
The change from baseline in chest distress scale at day 3.
Description
The change from baseline in chest distress scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 3.
Time Frame
from baseline to day 3
Title
The change from baseline in chest distress scale at the day before hospital discharge.
Description
The change from baseline in chest distress scale (ranging from 0-4, with higher scores indicating severer outcomes) at the day before hospital discharge.
Time Frame
up to 14 days (from baseline to the day before hospital discharge)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-jie Guan, PhD
Organizational Affiliation
Guangzhou Institute of Respiratory Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32167524
Citation
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. Erratum In: JAMA Intern Med. 2020 Jul 1;180(7):1031.
Results Reference
background
PubMed Identifier
32085846
Citation
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. Erratum In: Lancet Respir Med. 2020 Feb 25;:
Results Reference
background
PubMed Identifier
30227423
Citation
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.
Results Reference
background
PubMed Identifier
25118308
Citation
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.
Results Reference
background
PubMed Identifier
16927073
Citation
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.
Results Reference
background

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

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