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Trial - ChiCTR2000040847


Column Value
Trial registration number ChiCTR2000040847
Full text link
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Weihui Fu

Contact
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

fuweihui4011@163.com

Registration date
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2020-12-11

Recruitment status
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Recruiting

Study design
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Center
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. Aged from 18 to 70 years old, 2.The diagnostic criteria of subjects clearly defined as SARS-CoV-2 infected pneumonia shall be based on the criteria of severe patients stipulated in the Novel Coronavirus Infected Pneumonia Protocol (Trial version vii) issued by the National Health Commission, 3. Patients can receive aerosol inhalation, 4. Consent to sign a written informed statement prior to the beginning of the study.

Exclusion criteria
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

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.

Number of arms
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Shanghai Public Health Clinical Center

Inclusion age min
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

70

Countries
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

China

Type of patients
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Severe disease at enrollment

Severity scale
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

6: Severe disease at enrollment

Total sample size
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

20

primary outcome
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Viral load;Clinical Symptoms (Fever; Cough...);Inflammation;Pulmonary imaging;In-hospital days;

Notes
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

| Declared number of arm (2.0) differs from found arms (3.0)

Phase
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 0

Arms
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 43, "treatment_name": "Aerosol inhalation", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]