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Trial - ChiCTR2000029742


Column Value
Trial registration number ChiCTR2000029742
Full text link
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Qin Ning

Contact
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

31531955@qq.com

Registration date
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2020-02-11

Recruitment status
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Recruiting

Study design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Center
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. Aged >=18 to 70 years, 2. Diagnosed 2019-nCoV infected patients by viral nucleic acid,or although the test was negative and even not be detected, the reseachers judged it to be a novel coronavirus pneumonia, 3. Understand and agree to participate in this study and sign informed consent, 4. According to the guideline of clinical classification of novel coronavirus pneumonia (2019-nCoV) diagnosis and treatment plan (trial version fifth), the general patients were included in the selection criteria: fever, respiratory tract symptoms, imaging findings of pneumonia, Severe patients were selected according to the following criteria: 1) respiratory distress, RR >= 30 times / minute, 2) resting state, mean oxygen saturation less than 93%, 3) artery. PaO2 / FiO2 <= 300MMHG (1mmhg = 0.133kpa).

Exclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. Pregnant or lactating women, or pregnant, 2. Those who are allergic to the drug ingredients of this program, 3. Severe cardiovascular diseases, such as severe center of gravity dysfunction, second or third degree atrioventricular block, etc., 4. Severe hepatic insufficiency: defined as the upper limit of ALT > 2 times normal value or AST > 2 times normal value, 5. Severe renal insufficiency: defined as creatinine > 1.5 times the upper limit of normal value, 6. Have asthma, COPD serious respiratory disease, 7. Serious blood diseases, such as coagulation disorders, systemic bleeding, platelet diseases, etc, 8. Serious endocrine system diseases, such as type II diabetes, 9. Patients with malignant tumor, 10. Patients taking antiedematous drugs for a long time, 11. Major operation history, 12. Other clinical researchers.

Number of arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

5

Funding
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Tongji Hospital;Tongji Medical College; Huazhong University of Science and Technology

Inclusion age min
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

70

Countries
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

China

Type of patients
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

90

primary outcome
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Chest imaging (CT);

Notes
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

| Declared number of arm (5.0) differs from found arms (6.0)

Phase
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 4

Arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 329, "treatment_name": "Corticosteroid", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1212, "treatment_name": "Sodium aescinate", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1212, "treatment_name": "Sodium aescinate", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]