Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental group:Hydrogen-Oxygen Nebulizer
Control group:Oxygen concentrator
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Subjects participating in this clinical study must meet all of the following criteria: 1. General- severe hospitalized patients who meet the diagnostic criteria of the "New Coronavirus Infected Pneumonia Diagnosis and Treatment Plan (Trial Version 5)". That is, one of the following three conditions is met on the premise that the general diagnostic criteria are met: 1) Respiratory frequency (RR): 20-30 times / minute; 2) Peripheral oxygen saturation: 93-95%; 3) Arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2): 300-400mmHg (1mmHg = 0.133kPa). 2. Patients aged >= 18 and <= 85 years, with normal autonomous judgment ability, regardless of gender and region; 3. Patients who voluntarily participated in the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with a significant disease or condition other than the new coronavirus pneumonia, that is, a disease that, according to the investigator's judgment, may cause the subject to be at risk due to participation in the study, or affect the results of the study and the ability of the subject to participate in the study. 2. Women who are pregnant or nursing or plan to become pregnant during the study. 3. Have one of the following respiratory diseases: 1) Asthma: Based on the investigator's judgment, the subject is currently diagnosed with asthma. 2) Subjects with a previous history of COPD or long-term medication or imaging that showed significant lung structural damage (eg, giant pulmonary bullae). 3) Other respiratory diseases: subjects with other active lung diseases, such as active tuberculosis, lung cancer, wet bronchiectasis (high-resolution CT shows bronchiectasis, yellow sputum every day), sarcoidosis, idiopathic Interstitial Pulmonary Fibrosis (IPF), Primary Pulmonary Arterial Hypertension, Uncontrolled Sleep Apnea (ie, the severity of the disease will affect the implementation of the study at the investigator's discretion), combined with pneumothorax, pleural effusion and pulmonary embolism , Bronchial asthma, tumors, fever of unknown origin, etc. 4) Lung volume reduction: Lung volume reduction, lobectomy, or bronchoscopic lung volume reduction within 6 months (bronchial obstruction, airway bypass, bronchial valve, steam thermal ablation, biological sealant, Implants). 5) Patients who are critically ill or unstable. Definition of Severe Pneumonia: A. Increased breathing rate ( >= 30 beats / min), difficulty breathing; B. Peripheral blood oxygen saturation 50% within 48 hours; D. Combined with pneumothorax. 6) Pneumonia risk factors: immunosuppression (HIV), severe neurological disease affecting upper respiratory tract control, or other risk factors that the investigator believes may put the subject at a significant risk of pneumonia. 4. Complicate serious primary diseases such as heart, liver, kidney, and hematopoietic system. 5. People with mental disorders and cognitive impairment. 6. Non-compliance: Subjects who did not comply with the study procedures, including non-compliance completion logs. 7. Questions about the effectiveness of informed consent: subjects with a history of psychosis, mental retardation, poor motivation, substance abuse (including drugs and alcohol), or other medical conditions that limit the effectiveness of informed consent in this study. 8. Those who use non-expectorant antioxidant drugs, including large doses of vitamin C and vitamin E. 9. Researchers consider it inappropriate to participate in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the condition worsens and develops into severe or critical condition;the condition improves significantly and reaches the discharge standard;The overall treatment time is no longer than 14 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time from the patient's enrollment to the progression to severe or critical condition;The time from patient enrollment to clinical remission: clinical symptom relief is defined as: the patient's body temperature is normal for > 72 hours (without taking antipyretic drugs or hormones) and there is no conscious dyspnea or dyspnea decreases;disease recovery time (up to discharge standard);duration of fever;Proportion of patients with normal body temperature within 14 days after enrollment;Evaluation of respiratory symptoms, coughing condition was assessed by Leicester Cough Questionnaire (LCQ);Proportion of patients without cough 14 days after enrollment;Proportion of patients without dyspnea in 14 days after enrollment;Laboratory examination of blood routine, C-reactive protein, myocardial enzymes, liver function, renal function, muscle enzymes, etc.;On the 14th day after enrollment, the negative rate of novel coronavirus nucleic acid in respiratory specimens of patients was negative.; | — |
Countries
China
Contacts
Public ContactNanshan Zhong, Zeguang Zheng
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed