Patients who are diagnosed with mild, moderate or severe COVID-19 confirmed by COVID-19 nucleic acid test or rapid antigen detection
Conditions
Interventions
Test group: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 c
Control group: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, pro
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion 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
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 investigat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the percentage of subjects with clinical recovery on Day 7 of study treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects achieving clinical recovery on Day 2, 3, 5, and 10 of study treatment and before discharge;;Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more on Day 2, 3, 5, 7, and 10 of study treatment and before discharge;;Point reduction of WHO Clinical Progression Scale score on Day 2, 3, 5, 7, and 10 of study treatment and before discharge;;Changes in scores of COVID-19 related symptoms on Day 2, 3, 5, 7, and 10 of the study treatment and before discharge;;Percentage of subjects whose COVID-19 related symptoms have recovered to normal on Day 2, 3, 5, 7, and 10 of the study treatment and before discharge;;Total length of hospital stay;;Time from randomization to conversion to mild type of COVID-19;;Percentage of patients with fever, shortness of breath and chest pain all disappeared on Day 2, 3, 5, 7, and 10 of study treatment and before discharge;;Oxygen saturation in resting non-oxygen inhalation state;;Change of inflammation indicators (C-reactive protein [CRP], IL-6, ferritin, lymphocytes, neutrophil to lymphocyte ratio) on Day 3, 7, 10 of study treatment and before discharge compared with that before study treatment.; | — |
Countries
China
Contacts
Public ContactWeiJie Guan
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed