Covid-19, Dyspnea, Hydrogen/Oxygen Mixed Gas
Conditions
Keywords
Covid-19, Hydrogen/oxygen mixed gas, Dyspnea
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.
Interventions
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.
OTHERStandard-of-care
Standard-of-care consisted of the supportive therapies (including oxygen therapy) recommended by the Chinese National Health Commission
Sponsors
Guangzhou Institute of Respiratory Disease
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with improved disease severity at day 2 | from baseline to 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 | from baseline to 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| The change from baseline in dyspnea scale at day 2. | 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. |
| The change from baseline in dyspnea scale at day 3. | 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. |
| The change from baseline in dyspnea scale 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 (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 | 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 |
| The change from baseline in cough scale at day 3 | 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 |
| The change from baseline in cough scale 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 (ranging from 0-4, with higher scores indicating severer outcomes) at the day before hospital discharge |
| The change from baseline in oxygen saturation at day 2. | from baseline to day 2 | The change from baseline in oxygen saturation at day 2. |
| The change from baseline in chest pain scale at day 3. | 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. |
| The change from baseline in chest pain scale 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 (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. | 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. |
| The change from baseline in chest distress scale at day 3. | 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. |
| The change from baseline in chest distress scale 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 (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. | 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. |
| The change from baseline in oxygen saturation at day 3. | from baseline to 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 | 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. |
Countries
China
Outcome results
None listed