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| Column | Value |
|---|---|
| Trial registration number | NCT05539664 |
|
Full text link
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
None |
|
Registration date
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
2022-09-14 |
|
Recruitment status
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
inclusion criteria: male and female subjects aged between 18 and 80 years old (inclusive). 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). subjects who are willing to participate and provided written informed consent form. |
|
Exclusion criteria
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
diagnosed as mild, severe, critical or asymptomatic type of covid-19. subjects in the treatment or active stage of malignant tumor. subjects who are intolerable to inhalation treatment. subjects with mental disorders or cognitive impairment who are unable to provide consent. subjects with any immunodeficiency requiring chronic treatment with any corticosteroid or other immunosuppressants. 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. subjects who are using any non-expectorant antioxidant drug, including large doses of vitamin c and vitamin e. subjects who are participating any other clinical study of any investigational drug or medical device. pregnant or lactating women. any other condition judged as inappropriate to participate in this study by the investigator. |
|
Number of arms
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
Ruijin Hospital |
|
Inclusion age min
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
80 |
|
Countries
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
China |
|
Type of patients
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
Moderate disease at enrollment |
|
Severity scale
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
3: Moderate disease at enrollment |
|
Total sample size
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
188 |
|
primary outcome
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
Time to negative viral nucleic acid detection from the start of the study treatment. |
|
Notes
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : Sept. 16, 2022, 2 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 605, "treatment_name": "Hydrogen-oxygen nebulizer", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |