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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04378712
Recruitment Status : Completed
First Posted : May 7, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Weijie Guan, Guangzhou Institute of Respiratory Disease

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.

Condition or disease Intervention/treatment Phase
Covid-19 Hydrogen/Oxygen Mixed Gas Dyspnea Device: Hydrogen Oxygen Generator with Nebulizer Other: Standard-of-care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 21, 2020
Actual Primary Completion Date : March 23, 2020
Actual Study Completion Date : March 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
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
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.

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

Control Group
Usual care referred to the standard-of-care (including oxygen therapy) recommended by Chinese National Health Commission.
Other: Standard-of-care
Standard-of-care consisted of the supportive therapies (including oxygen therapy) recommended by the Chinese National Health Commission




Primary Outcome Measures :
  1. The proportion of patients with improved disease severity at day 2 [ Time Frame: from baseline to day 2 ]
    The proportion of patients with improved disease severity (by at least one scale) at day 2

  2. The proportion of patients with improved disease severity at day 3 [ Time Frame: from baseline to day 3 ]
    The proportion of patients with improved disease severity (by at least one scale) at day 3

  3. The proportion of patients with improved disease severity at the day before hospital discharge [ Time Frame: up to 14 days (from baseline to 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 :
  1. The change from baseline in oxygen saturation at day 2. [ Time Frame: from baseline to day 2 ]
    The change from baseline in oxygen saturation at day 2.

  2. The change from baseline in oxygen saturation at day 3. [ Time Frame: from baseline to day 3 ]
    The change from baseline in oxygen saturation at day 3.

  3. 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) ]
    The change from baseline in oxygen saturation at the day before hospital discharge.

  4. The change from baseline in dyspnea scale at day 2. [ Time Frame: from baseline to day 2 ]
    The change from baseline in dyspnea scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 2.

  5. The change from baseline in dyspnea scale at day 3. [ Time Frame: from baseline to day 3 ]
    The change from baseline in dyspnea scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 3.

  6. The change from baseline in dyspnea scale at the day before hospital discharge. [ Time Frame: up to 14 days (from baseline to 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.

  7. The change from baseline in cough scale at day 2 [ Time Frame: from baseline to day 2 ]
    The change from baseline in cough scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 2

  8. The change from baseline in cough scale at day 3 [ Time Frame: from baseline to day 3 ]
    The change from baseline in cough scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 3

  9. The change from baseline in cough scale at the day before hospital discharge [ Time Frame: up to 14 days (from baseline to 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

  10. The change from baseline in chest pain scale at day 2. [ Time Frame: from baseline to day 2 ]
    The change from baseline in chest pain scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 2.

  11. The change from baseline in chest pain scale at day 3. [ Time Frame: from baseline to day 3 ]
    The change from baseline in chest pain scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 3.

  12. The change from baseline in chest pain scale at the day before hospital discharge. [ Time Frame: up to 14 days (from baseline to 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.

  13. The change from baseline in chest distress scale at day 2. [ Time Frame: from baseline to day 2 ]
    The change from baseline in chest distress scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 2.

  14. The change from baseline in chest distress scale at day 3. [ Time Frame: from baseline to day 3 ]
    The change from baseline in chest distress scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 3.

  15. The change from baseline in chest distress scale at the day before hospital discharge. [ Time Frame: up to 14 days (from baseline to 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04378712


Locations
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China, Guangdong
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
Investigators
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Principal Investigator: Wei-jie Guan, PhD Guangzhou Institute of Respiratory Disease
Publications:

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Responsible Party: Weijie Guan, Associate professor of respiratory medicine, co-principal investigator, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT04378712    
Other Study ID Numbers: JT202005LZ
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weijie Guan, Guangzhou Institute of Respiratory Disease:
Covid-19
Hydrogen/oxygen mixed gas
Dyspnea
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory