This is a multi-center, randomized, parallel controlled, double-blinded clinical trial toevaluate the effectiveness and safety of Hydrogen-Oxygen Generator with Nebulizer foradjuvant treatment of COVID-19 patients. The test group is expected to be superior to thecontrol group in the primary endpoint (percentage of subjects achieving clinical recoveryat Day 7 of study treatment). Subjects in the test group will receive treatment by usingHydrogen-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 ofthe subjects); and subjects in the control group will receive treatment by using MedicalMolecular Sieve Oxygen Generator (manufactured by Shanghai Ouliang Medical Devices Co.,Ltd., flow rate: 3L/min, provided by the sponsor) combined with conventional basicsupportive treatment (same with that in the test group).
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.
Device: Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03
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);
Device: OLO-1 Medical Molecular Sieve Oxygen Generator
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).
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.
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Guan Wei-jie, PhD
+86-13826042052
battery203@163.com
Guan Weijie, PhD, Principal Investigator
Guangzhou Institute of Respiratory Disease