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

May 13, 2020 updated by: Weijie Guan, Guangzhou Institute of Respiratory Disease

Effects of Hydrogen/Oxygen Mixed Gas Inhalation for Patients With Coronavirus Disease 2019 (COVID-19) Who Had Dyspnea: A Multicenter, Open-label Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from baseline to day 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
from baseline to day 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
up to 14 days (from baseline to the day before hospital discharge)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from baseline to day 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.
from baseline to day 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.
up to 14 days (from baseline to the day before hospital discharge)
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.
from baseline to day 2
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.
from baseline to day 3
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.
up to 14 days (from baseline to the day before hospital discharge)
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
from baseline to day 2
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
from baseline to day 3
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
up to 14 days (from baseline to the day before hospital discharge)
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.
from baseline to day 2
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.
from baseline to day 3
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.
up to 14 days (from baseline to the day before hospital discharge)
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.
from baseline to day 2
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.
from baseline to day 3
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.
up to 14 days (from baseline to the day before hospital discharge)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Institute of Respiratory Disease

Investigators

  • Principal Investigator: Wei-jie Guan, PhD, Guangzhou Institute of Respiratory Disease

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2020

Primary Completion (Actual)

March 23, 2020

Study Completion (Actual)

March 23, 2020

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2020

Last Update Submitted That Met QC Criteria

May 13, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JT202005LZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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