| Trial registration number
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ChiCTR2000030262 |
Full text link
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.chictr.org.cn/showproj.aspx?proj=50136
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First author
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Jianqing Xu
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Contact
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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xujianqing@shphc.org.cn
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Registration date
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2020-02-26
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Recruitment status
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Center
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Aged from 18 to 70 years old,
2. According with the clinical diagnosis of viral pneumonia symptoms,including fever, Low white blood cells or platelets infiltration shadow in CT,
3. Positive result for nucleic acid of 2019-nCov,
4. Patients can receive aerosol inhalation
5. Consent to sign a written informed statement prior to the beginning of the study.
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Exclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Pneumonia caused by other viruses, except for 2019-nCov,
2. Clear bacterial infection,
3. Subjects who have used antiviral drugs and may need another antiviral treatment during the study,
4. There are serious non-infectious pulmonary diseases, including tuberculosis, pulmonary edema and pulmonary embolism,
5. Severe liver and kidney dysfunction,
6. Participating in other clinical studies within 30 days before administration,
7. Allergic to type 1 interferon,
8. Pregnant or lactating women,
9.In any other case, if the investigator thinks it is not suitable for the trial, or it may increase the risk of the subject or interfere with the clinical trial.
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Number of arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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4
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Funding
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Shanghai Public Health Clinical Center
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Inclusion age min
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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70
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Countries
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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China
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Type of patients
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Moderate/severe/critical disease at enrollment
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Severity scale
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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5: Moderate/severe/critical disease at enrollment
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Total sample size
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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140
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primary outcome
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Viral load;Clinical features;Inflammation;Pulmonary imaging;In-hospital days;
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Notes
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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| Declared number of arm (4.0)
differs from found arms (5.0)
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Phase
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 0
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Arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 2033, "treatment_name": "Interferon kappa+tff2", "treatment_type": "Interferons+others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2033, "treatment_name": "Interferon kappa+tff2", "treatment_type": "Interferons+others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2033, "treatment_name": "Interferon kappa+tff2", "treatment_type": "Interferons+others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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