This is a prospective, multicenter, randomized, controlled, superiority clinical trial.It is expected that the test group would have better effectiveness than the control groupin the primary evaluation indicator (time to negative viral nucleic acid detection fromthe start of study treatment). The test group will use the investigational medical deviceHydrogen-Oxygen Generator with Nebulizer (Shanghai Asclepius Meditec Co., Ltd.) + basictreatment (the investigator provides corresponding symptomatic support treatment based onthe condition of the patients), and the control group will use the hospital routineoxygen supply equipment (wall oxygen or cylinder oxygen) + basic treatment, to evaluatethe effectiveness and safety of the investigational medical device Hydrogen-OxygenGenerator with Nebulizer for adjuvant treatment of COVID-19 patients.
A total of 188 subjects who met the requirements of this study will be randomized into
the test group or the control group in a 1:1 ratio to receive treatment, and the subjects
will be observed and evaluated in the period from treatment after enrollment to
discharge.
All enrolled subjects will receive treatment and visit, including screening visit (within
3 days before enrollment), randomization and treatment visit (Day 0), 1, 2, 3, 5, 7, 10,
and discharge visit after treatment.
The primary effectiveness evaluation indicator (time to negative viral nucleic acid
detection from the start of the study treatment), the secondary effectiveness evaluation
indicators (viral nucleic acid negative conversion rate, imaging evaluation, inflammatory
indicators such as CRP, IL-6, lymphocytes, clinical response rate at 7 days of treatment,
recovery rate and recovery time of major symptoms, index oxygen saturation, and Ct value
of nucleic acid detection), and safety evaluation indicators ( incidence of AE and SAE,
incidence of device deficiencies) of the two groups will be collected and analyzed.
Device: Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03
The experimental group used the experimental medical device Hydrogen-Oxygen Generator
with Nebulizer(Shanghai Asclepius Meditec Co., Ltd. ) The flow rate was 3L/min, and the
cumulative treatment time was not less than 6 hours per day.
Device: the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen)
the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen). The flow
rate was 3L/min, and the cumulative treatment time was not less than 6 hours per day.
Inclusion Criteria:
- Male and female subjects aged between 18 and 80 years old (inclusive).
- Diagnosed as general type of COVID-19 according to the criteria of Scheme for
Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (Trial Version 9).
- Subjects who are willing to participate and provided written informed consent form.
Exclusion Criteria:
- Diagnosed as mild, severe, critical or asymptomatic type of COVID-19.
- Subjects in the treatment or active stage of malignant tumor.
- Subjects who are intolerable to inhalation treatment.
- Subjects with mental disorders or cognitive impairment who are unable to provide
consent.
- Subjects with any immunodeficiency requiring chronic treatment with any
corticosteroid or other immunosuppressants.
- Complicate serious primary diseases such as heart, liver, kidney, and hematopoietic
diseases; acute exacerbation phase of chronic obstructive pulmonary disease, or
acute attack of bronchial asthma.
- Subjects who are using any non-expectorant antioxidant drug, including large doses
of vitamin C and vitamin E.
- Subjects who are participating any other clinical study of any investigational drug
or medical device.
- Pregnant or lactating women.
- Any other condition judged as inappropriate to participate in this study by the
investigator.
Ruijin Hospital, Medical School of Shanghai Jiaotong University
Shanghai, Shanghai, China
Not Provided