This study will evaluate the efficacy and safety of Hydrogen-Oxygen Generator with Nebulizer (model AMS-H-03) developed by Shanghai Asclepius Meditech Co., Ltd. as an adjuvant therapy for the patients with COVID-19 infected pneumonia in improving the clinical symptoms and reducing the incidence of severe pneumonia, as compared with the reference device of EverFlo Oxygen Concentrator (registration certificate No.: NMPA Registration Standard: 20162542389) manufactured by Respironics, Inc. US.
A multi-center, randomized, parallel-controlled clinical trial design is used in this study.
Eligible subjects will be randomized into the study group and control group in a 1:1 ratio.
In addition to the supportive treatments depending on the condition, the subjects in the
study group will inhale the mixed gas of hydrogen/oxygen (hydrogen concentration 66%, oxygen
concentration 33%) at a flow rate of 6 L/min every day using the Hydrogen/Oxygen Generator
with Nebulizer (model AMS-H-03) developed by Shanghai Asclepius Meditech Co., Ltd. during the
treatment, with the total use of no less than 6 hours per day, and the other combination
treatments will be decided by the investigator depending on the clinical needs; the subjects
in the control group will inhale the gas at a flow rate of 2 L/min every day using the
reference device of EverFlo Oxygen Concentrator (registration certificate No.: NMPA
Registration Standard: 20162542389) developed by Respironics, Inc. US. during the treatment,
with the total use of no less than 6 hours per day, and the other combination treatments will
be decided by the investigator depending on the clinical needs. During the treatment, the
peripheral blood oxygen saturation should be monitored and the oxygen concentration should be
increased when necessary (the peripheral oxygen saturation is less than 95% for 30 seconds
and other causes have been excluded). Oxygen may be supplied by other devices if the oxygen
concentration is sufficient for the subjects in the study group. The oxygen saturation and
respiratory rate will be measured at the resting state every day during the treatment, namely
after the end of daily treatment and 30 minutes after the inhalation of oxygen and
hydrogen/oxygen.
Device: oxyhydrogen
Hydrogen-Oxygen Generator with Nebulizer Model: AMS-H-03 Gas production: 2.0 L/min, 2.5 L/min, and 3 L/min, three gears in total (in this study, the gas production of each machine is 3 L/min, two sets are connected and used together by three-way connection, and the total gas production is 6 L/min.) Manufacturer: Shanghai Asclepius Meditech Co., Ltd.
Other Name: Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 6 hour a day.
Device: Oxygen
oxygen inhaled,3 L/min . 6 hour a day.
Inclusion Criteria:
All subjects participating in this clinical study must meet all of the following criteria:
1. According to the Diagnosis and Treatment Protocol for COVID-19 (Trial Version 5),
under the premise of meeting the diagnostic criteria of moderate COVID-19, the
subjects should meet one of the following three conditions:
① Respiratory rate (RR): ≥ 20 times/min;
② In the state of air absorption and rest, the peripheral oxygen saturation is lower
than 95%;
③ Arterial partial pressure of oxygen (PaO2)/FiO2: ≤ 400 mmHg (1mmHg=0.133 kPa).
2. ≥18 years old and ≤85 years old subjects with normal autonomous judgment, regardless
of gender and region;
3. Subjects voluntarily participate in the study and have signed the informed consent
form.
Exclusion Criteria:
1. Have other significant diseases other than COVID-19, that is, a disease that,
according to the investigator's judgment, can cause the subject to be at risk due to
participation in the study, or affect the study results and the ability of the subject
to participate in the study.
2. Women who are pregnant or breastfeeding or plan to be pregnant during the study.
3. Subjects with one of the following respiratory diseases:
1. Asthma: Based on the investigator's judgment, the subjects are currently
diagnosed with asthma.
2. Subjects with a long-term history of COPD and medication or imaging evidence of
significant lung structural damage (e.g., giant pulmonary bullae).
Other respiratory diseases: Subjects with other active pulmonry diseases, such as
active tuberculosis, lung cancer, wet bronchiectasis (the high-resolution CT shows
bronchiectasis, with yellow sputum every day), sarcoidosis, idiopathic interstitial
pulmonary fibrosis (IPF), primary pulmonary arterial hypertension, and uncontrolled
sleep apnea (the severity of the disease will affect the implementation of c)the study
according to the investigator's judgment), complicated with pneumothorax, pleural
effusion, pulmonary embolism, bronchial asthma, tumor, and fever of unknown origin,
etc.
d)Lung volume reduction: Subjects received lung volume reduction, lobectomy, or
bronchoscopic lung volume reduction (endobronchial occlusion, airway bypass,
endobronchial valve, steam thermal ablation, biological sealant and airway implant)
within 6 months.
e)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. With other organ failure, ICU monitoring and treatment is needed.
f)Risk factors for pneumonia: 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.
4. Subjects with serious primary diseases of heart, liver, kidney, hematopoietic system
and other important organs or systems.
5. Subjects with mental disorder and cognitive impairment.
6. Subjects who do not follow the study steps.
7. Patients with doubts about the effectiveness of informed consent: Subjects with mental
illness, mental retardation, poor motivation, drug abuse (including drugs and alcohol)
or other disease history restricting the effectiveness of informed consent in this
study.
8. Use of non-expectorants and antioxidants, including large doses of vitamin C and
vitamen E.
9. Subjects who are not suitable for participation in this study in the judgment of
investigator.
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Investigator: Zheng Z Guang, doctor
Contact: 86-20-83062843
zheng862080@139.com
Zhang Ze Guang, doctor
18928868242
zheng862080@139.com
Xin Yong Lin, master
13901754567
ceo@ascleway.com