AMS-H-03, Covid19, Hydrogen-oxygen Gas
Conditions
Keywords
Covid19, Hydrogen-oxygen Gas, AMS-H-03
Brief summary
This is a multi-center, randomized, parallel controlled, double-blinded clinical trial to evaluate the effectiveness and safety of Hydrogen-Oxygen Generator with Nebulizer for adjuvant treatment of COVID-19 patients. The test group is expected to be superior to the control group in the primary endpoint (percentage of subjects achieving clinical recovery at Day 7 of study treatment). Subjects in the test group will receive treatment by using Hydrogen-Oxygen Generator with Nebulizer (manufactured by Shanghai Asclepius Meditec Co., Ltd., flow rate: 3L/min) combined with conventional basic supportive treatment (symptomatic support treatment determined by the investigator based on the condition of the subjects); and subjects in the control group will receive treatment by using Medical Molecular Sieve Oxygen Generator (manufactured by Shanghai Ouliang Medical Devices Co., Ltd., flow rate: 3L/min, provided by the sponsor) combined with conventional basic supportive treatment (same with that in the test group).
Detailed description
Data of the following effectiveness and safety endpoints of subjects in the two groups will be collected and analyzed in this study, including of the primary effectiveness endpoint: percentage of subjects achieving clinical recovery at Day 7 of study treatment; and the secondary effectiveness endpoints: percentage of subjects achieving clinical recovery on Day 2, 3, 5, 10 of study treatment and that before discharge; percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more on Day 2, 3, 5, 7, 10 of study treatment and before discharge; reduction of WHO Clinical Progression Scale score on Day 2, 3, 5, 7, 10 of study treatment and before discharge; changes in COVID-19 symptom scores on Day 2, 3, 5, 7, 10 of study treatment and before discharge; total length of hospital stay; time from randomization to conversion to general COVID-19; time from randomization to conversion to mild COVID-19 disease; percentage of patients with no fever, shortness of breath and chest pain on Day 2, 3, 5, 7, 10 of study treatment and before discharge; Oxygen saturation based on finger blood samples in resting non-oxygen inhalation state; and safety evaluation variables including incidences of AEs, SAEs and device deficiencies.
Interventions
Subjects in the experimental group will receive treatment by using Hydrogen-Oxygen Generator with Nebulizer (manufactured by Shanghai Asclepius Meditec Co., Ltd., flow rate: 3L/min) combined with conventional basic supportive treatment (symptomatic support treatment determined by the investigator based on the condition of the subjects);
subjects in the control group will receive treatment by using Medical Molecular Sieve Oxygen Generator (manufactured by Shanghai Ouliang Medical Devices Co., Ltd., flow rate: 3L/min, provided by the sponsor) combined with conventional basic supportive treatment (same with that in the test group).
Sponsors
Guangzhou Institute of Respiratory Disease
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Subjects in the test group will receive treatment by using Hydrogen-Oxygen Generator with Nebulizer (manufactured by Shanghai Asclepius Meditec Co., Ltd., flow rate: 3L/min) combined with conventional basic supportive treatment (symptomatic support treatment determined by the investigator based on the condition of the subjects); subjects in the control group will receive treatment by using Medical Molecular Sieve Oxygen Generator (manufactured by Shanghai Ouliang Medical Devices Co., Ltd., flow rate: 3L/min, provided by the sponsor) combined with conventional basic supportive treatment (same with that in the test group).
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects aged between 18 and 75 years old (inclusive). 2. Diagnosed with mild, moderate or severe type of COVID-19 according to the criteria of Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (Trial Version 10). 3. Positive result for COVID-19 nucleic acid test or rapid antigen detection at screening visit; 4. Presenting with at least one respiratory symptom (e.g. dyspnoea, shortness of breath) at hospital admission. 5. Be willing to participate in this trial and provide written informed consent form.
Exclusion criteria
1. Subjects with critical or asymptomatic type of COVID-19; 2. Subjects with any known malignant tumor or life expectancy less than half a year. 3. Subjects who are intolerable to inhalation treatment. 4. Subjects with mental disorders or cognitive impairment who are unable to provide consent. 5. Subjects with any immunodeficiency requiring chronic treatment with any corticosteroid or other immunosuppressants. 6. Complicate with any serious cardiac, hepatic or renal disease (as indicated by aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\] ≥ 2 × upper limit of normal \[ULN\], or creatinine ≥ 176.8mmol/L, or New York Heart Association (NYHA) Classification for heart failure of Class IV) or any serious primary systematic disease. 7. Subjects who are going to use any non-expectorant antioxidant drug, including large doses of vitamin C and vitamin E during the study period. 8. Subjects who are participating in any other clinical study on any investigational drug or medical device. 9. Pregnant or lactating women. 10. Subjects with any other condition judged as inappropriate to participate in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the percentage of subjects with clinical recovery on Day 7 of study treatment. | Day 7of study treatment | continuous clinical recovery is defined as score (see Appendix 2) of COVID-19 related symptoms ≤ 1 continued for 2 consecutive days or discharge criteria is met. Time of continuous clinical recovery is defined as time (days) between the first initiation of the study treatment devices and the time when the score of relevant COVID-19 related symptoms ≤ 1 continues for 2 consecutive days or discharge criteria is met (whichever comes first). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects achieving clinical recovery | Day 2of study treatment | continuous clinical recovery is defined as score (see Appendix 2) of COVID-19 related symptoms ≤ 1 continued for 2 consecutive days or discharge criteria is met. Time of continuous clinical recovery is defined as time (days) between the first initiation of the study treatment devices and the time when the score of relevant COVID-19 related symptoms ≤ 1 continues for 2 consecutive days or discharge criteria is met (whichever comes first). |
| Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more | Day 2 of study treatment | Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more |
| Point reduction of WHO Clinical Progression Scale score | Day 2 of study treatment | Point reduction of WHO Clinical Progression Scale score |
| Changes in scores of COVID-19 related symptoms | Day 2 of the study treatment | Changes in scores of COVID-19 related symptoms |
| Percentage of subjects whose COVID-19 related symptoms have recovered to normal | Day 2 of the study treatment | Percentage of subjects whose COVID-19 related symptoms have recovered to normal |
| Total length of hospital stay | through study completion, an average of 14 days | Total length of hospital stay |
| Time from randomization to conversion to mild type of COVID-19 | Time from randomization to conversion to mild type of COVID-19 | Time from randomization to conversion to mild type of COVID-19 |
| neutrophil to lymphocyte ratio | Day 3 of study treatment | neutrophil to lymphocyte ratio |
| Percentage of patients with fever, shortness of breath and chest pain all disappeared | Day 2 of study treatment | Percentage of patients with fever, shortness of breath and chest pain all disappeared |
| Oxygen saturation in resting non-oxygen inhalation state | Day 2 of study treatment | Oxygen saturation will be measured based on finger blood samples in resting state at 10 minutes after stopping the use of the study device for subjects in the test group and the control group |
| CRP | Day 3 of study treatment | C-reactive protein |
| IL-6 | Day 3 of study treatment | IL-6 |
| ferritin | Day 3 of study treatment | ferritin |
| lymphocytes | Day 3 of study treatment | lymphocytes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs/SAEs | through study completion, an average of 14 days | Definition: An AE is defined as any untoward medical occurrence during the course of the clinical trial, whether or not related to the study device. For the definition of SAE |
| Incidence of Device Deficiency | through study completion, an average of 14 days | Definition: a device deficiency is defined as any inadequacy of a medical device which may pose inappropriate risks to the health or safety of the subjects under normal use of the device during the clinical trial, including inadequate labelling, quality issue, and malfunctions, etc. |
Countries
China
Contacts
Primary ContactGuan Wei-jie, PhD
Outcome results
None listed