Status:
UNKNOWN
Hydrogen-Oxygen Generator With Nebulizer in the Improvement of Symptoms in Patients Infected With COVID-19
Lead Sponsor:
Shanghai Asclepius Meditec Inc.
Collaborating Sponsors:
Shanghai Public Health Clinical Center
Henan Provincial People's Hospital
Conditions:
COVID-19
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- All subjects participating in this clinical study must meet all of the following criteria:
- 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).
- ≥18 years old and ≤85 years old subjects with normal autonomous judgment, regardless of gender and region;
- Subjects voluntarily participate in the study and have signed the informed consent form.
Exclusion
- 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.
- Women who are pregnant or breastfeeding or plan to be pregnant during the study.
- Subjects with one of the following respiratory diseases:
- Asthma: Based on the investigator's judgment, the subjects are currently diagnosed with asthma.
- 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.
- Subjects with serious primary diseases of heart, liver, kidney, hematopoietic system and other important organs or systems.
- Subjects with mental disorder and cognitive impairment.
- Subjects who do not follow the study steps.
- 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.
- Use of non-expectorants and antioxidants, including large doses of vitamin C and vitamen E.
- Subjects who are not suitable for participation in this study in the judgment of investigator.
Key Trial Info
Start Date :
February 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04336462
Start Date
February 15 2020
End Date
August 1 2020
Last Update
April 7 2020
Active Locations (1)
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1
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000