Clinical trial NCT05770206: Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of Novel Coronavirus Disease 2019 (COVID-19)
Official title: 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 Novel Coronavirus Disease 2019 (COVID-19)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Hydrogen-oxygen Gas
AMS-H-03
Keywords: Covid19
Hydrogen-oxygen Gas
AMS-H-03
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the percentage of subjects with clinical recovery on Day 7 of study treatment.
timeFrame: Day 7of study treatment
Secondary outcomes:
measure: Percentage of subjects achieving clinical recovery
timeFrame: Day 2of study treatment
measure: Percentage of subjects achieving clinical recovery
timeFrame: Day 3 of study treatment
measure: Percentage of subjects achieving clinical recovery
timeFrame: Day 5of study treatment
measure: Percentage of subjects achieving clinical recovery
timeFrame: Day 10 of study treatment
measure: Percentage of subjects achieving clinical recovery
timeFrame: through study completion, an average of 10 days
measure: Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
timeFrame: Day 2 of study treatment
measure: Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
timeFrame: Day 3 of study treatment
measure: Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
timeFrame: Day 5 of study treatment
measure: Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
timeFrame: Day 7 of study treatment
measure: Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
timeFrame: Day 10 of study treatment
measure: Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
timeFrame: The period from the beginning of treatment in patients enrolled to the time before discharge
measure: Point reduction of WHO Clinical Progression Scale score
timeFrame: Day 2 of study treatment
measure: Point reduction of WHO Clinical Progression Scale score
timeFrame: Day 3 of study treatment
measure: Point reduction of WHO Clinical Progression Scale score
timeFrame: Day 5 of study treatment
measure: Point reduction of WHO Clinical Progression Scale score
timeFrame: Day 7 of study treatment
measure: Point reduction of WHO Clinical Progression Scale score
timeFrame: Day 10 of study treatment
measure: Point reduction of WHO Clinical Progression Scale score
timeFrame: The period from the beginning of treatment in patients enrolled to the time before discharge
measure: Changes in scores of COVID-19 related symptoms
timeFrame: Day 2 of the study treatment
measure: Changes in scores of COVID-19 related symptoms
timeFrame: Day 3 of the study treatment
measure: Changes in scores of COVID-19 related symptoms
timeFrame: Day 5 of the study treatment
measure: Changes in scores of COVID-19 related symptoms
timeFrame: Day 7 of the study treatment
measure: Changes in scores of COVID-19 related symptoms
timeFrame: Day 10 of the study treatment
measure: Changes in scores of COVID-19 related symptoms
timeFrame: The period from the beginning of treatment in patients enrolled to the time before discharge
measure: Percentage of subjects whose COVID-19 related symptoms have recovered to normal
timeFrame: Day 2 of the study treatment
measure: Percentage of subjects whose COVID-19 related symptoms have recovered to normal
timeFrame: Day 3 of the study treatment
measure: Percentage of subjects whose COVID-19 related symptoms have recovered to normal
timeFrame: Day 5 of the study treatment
measure: Percentage of subjects whose COVID-19 related symptoms have recovered to normal
timeFrame: Day 7 of the study treatment
measure: Percentage of subjects whose COVID-19 related symptoms have recovered to normal
timeFrame: Day 10 of the study treatment
measure: Percentage of subjects whose COVID-19 related symptoms have recovered to normal
timeFrame: through study completion, an average of 10 days
measure: Total length of hospital stay
timeFrame: through study completion, an average of 14 days
measure: Time from randomization to conversion to mild type of COVID-19
timeFrame: Time from randomization to conversion to mild type of COVID-19
measure: Oxygen saturation in resting non-oxygen inhalation state
timeFrame: Day 2 of study treatment
measure: Oxygen saturation in resting non-oxygen inhalation state
timeFrame: Day 3 of study treatment
measure: Oxygen saturation in resting non-oxygen inhalation state
timeFrame: Day 5 of study treatment
measure: Oxygen saturation in resting non-oxygen inhalation state
timeFrame: Day 7 of study treatment
measure: Oxygen saturation in resting non-oxygen inhalation state
timeFrame: Day 10 of study treatment
measure: Oxygen saturation in resting non-oxygen inhalation state
timeFrame: through study completion, an average of 10 days
measure: CRP
timeFrame: Day 3 of study treatment
measure: CRP
timeFrame: Day 7 of study treatment
measure: CRP
timeFrame: Day 10 of study treatment
measure: CRP
timeFrame: through study completion, an average of 10 days
measure: IL-6
timeFrame: Day 3 of study treatment
measure: IL-6
timeFrame: Day 7 of study treatment
measure: IL-6
timeFrame: Day 10 of study treatment
measure: IL-6
timeFrame: through study completion, an average of 10 days
measure: ferritin
timeFrame: Day 3 of study treatment
measure: ferritin
timeFrame: Day 7 of study treatment
measure: ferritin
timeFrame: Day 10 of study treatment
measure: ferritin
timeFrame: through study completion, an average of 10 days
measure: lymphocytes
timeFrame: Day 3 of study treatment
measure: lymphocytes
timeFrame: Day 7of study treatment
measure: lymphocytes
timeFrame: Day 10 of study treatment
measure: lymphocytes
timeFrame: through study completion, an average of 10 days
measure: neutrophil to lymphocyte ratio
timeFrame: Day 3 of study treatment
measure: neutrophil to lymphocyte ratio
timeFrame: Day 7 of study treatment
measure: neutrophil to lymphocyte ratio
timeFrame: Day 10 of study treatment
measure: neutrophil to lymphocyte ratio
timeFrame: through study completion, an average of 10 days
measure: Percentage of patients with fever, shortness of breath and chest pain all disappeared
timeFrame: Day 2 of study treatment
measure: Percentage of patients with fever, shortness of breath and chest pain all disappeared
timeFrame: Day 3 of study treatment
measure: Percentage of patients with fever, shortness of breath and chest pain all disappeared
timeFrame: Day 5 of study treatment
measure: Percentage of patients with fever, shortness of breath and chest pain all disappeared
timeFrame: Day 7 of study treatment
measure: Percentage of patients with fever, shortness of breath and chest pain all disappeared
timeFrame: Day 10 of study treatment
measure: Percentage of patients with fever, shortness of breath and chest pain all disappeared
timeFrame: through study completion, an average of 10 days
Other outcomes:
measure: Incidence of AEs/SAEs
timeFrame: through study completion, an average of 14 days
measure: Incidence of Device Deficiency
timeFrame: through study completion, an average of 14 days
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Guangzhou Institute of Respiratory Disease
name: Guan Weijie, PhD
role: PRINCIPAL_INVESTIGATOR
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