COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=51859

Xianglin Yuan

yuanxianglin@hust.edu.cn

2020-04-01

Not recruiting

RCT

Randomized

Parallel

Not reported

single-center

Treatment

1) Aged 18 to 70 years old, 2) Infection with new coronavirus pneumonia was confirmed by throat swab nucleic acid test. Patients with severe and critical illness were clinically judged. The symptoms of acute infection have been alleviated after treatment (at least 14 days after onset, no fever for more than 3 days), and the disease is recovering Within three months, 3) CT examination of patients with multiple fibrotic shadows in both lungs, 4) Blood routine, liver, and kidney functions are within the controllable range: such as the normal upper limit of plasma total bilirubin and creatinine <=1.5 NUL, AST, ALT, LDH <=2 NUL, sufficient hematopoietic function: such as white blood cells >=4.0x10^9/L, platelets >=100x10^9/L, 5) Signed informed consent.

1) Previous history of chronic bronchitis, emphysema, interstitial lung disease or pulmonary heart disease, 2) Combining with other serious diseases: such as those who have suffered myocardial infarction and uncontrollable diabetes within 6 months, and are considered unsuitable to participate in the trial, 3) People with active peptic ulcer, 4) Patients during pregnancy and lactation, 5) Patients with mental illness or others who cannot cooperate effectively, 6) Researcher judged unsuitable to participate.

2

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

18

70

China

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

80

FVC;

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

Phase 4

[{"arm_notes": "", "treatment_id": 887, "treatment_name": "Nintedanib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]