Trial registration number
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ChiCTR2200060113 |
Full text link
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.chictr.org.cn/showproj.aspx?proj=170248
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First author
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Qu Jie-Ming
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Contact
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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liqingyun68@163.com
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Registration date
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2022-05-19
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Recruitment status
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Center
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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multi-center
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Study aim
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1.Male and female patients aged between 18 and 80 years old (inclusive).
2.Diagnosed as general type of COVID-19 according to the criteria of Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (Trial Version 9).
3.Patients who are willing to participate and provided written informed consent form.
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Exclusion criteria
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1.Diagnosed as mild, severe, critical or asymptomatic type of COVID-19.
2.Subjects in the treatment or active stage of malignant tumor.
3.Patients who are intolerable to inhalation treatment.
4.People with mental disorders or cognitive impairment who are unable to provide consent.
5.Patients with any immunodeficiency requiring chronic treatment with any corticosteroid or other immunosuppressants.
6.Complicate serious primary diseases such as heart, liver, kidney, and hematopoietic diseases, acute exacerbation phase of chronic obstructive pulmonary disease, or acute attack of bronchial asthma.
7.Patients who are using any non-expectorant antioxidant drug, including large doses of vitamin C and vitamin E.
8.Patients who are participating any other clinical study of any investigational drug or medical device.
9.Pregnant or lactating women.
10.Any other condition judged as inappropriate to participate in this study by the investigator.
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Number of arms
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Ruijin Hospital; Shanghai Jiao Tong University School of Medicine
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Inclusion age min
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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80
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Countries
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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China
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Type of patients
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Moderate disease at enrollment
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Severity scale
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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3: Moderate disease at enrollment
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Total sample size
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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188
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primary outcome
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Time to negative viral nucleic acid detection from the start of the study treatment.;
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Notes
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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| Declared number of arm (2.0)
differs from found arms (3.0)
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Phase
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 0
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Arms
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 605, "treatment_name": "Hydrogen-oxygen nebulizer", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1235, "treatment_name": "Standard oxygen", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]
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