COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49889

Huji Xu

xuhuji@smmu.edu.cn

2020-02-22

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

Subjects who meet the following conditions can become subjects of this study: 1. Will sign written informed consent. Adolescents or patients who cannot sign informed consent must obtain informed consent from the guardian, 2. Chinese aged >=18 years, 3. In accordance with NCP criteria for severe and critical illness, namely Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6) . Combined with the following epidemiological history, clinical manifestations, and pathogenic examinations to make a comprehensive judgment. 4. The course of disease is within 14 days after the onset of illness, 5. Will take nasopharyngeal or oropharyngeal swabs before administration.

1. Patients who are participating in other drug clinical trials, 2. Pregnant or lactating women, 3. ALT / AST> 5 ULN, neutrophils <0.5, platelets less than 50, 4. Expected survival is less than 1 week, 5. Patients diagnosed with rheumatic immune related diseases, 6. Take orally anti rejection drugs or immunomodulatory drugs for a long time, 7. Hypersensitive to adalimumab or any excipients, 8. Patients with active pulmonary tuberculosis, with definite bacterial and fungal infections

2

Shanghai Changzheng Hospital

18

None

China

Severe disease at enrollment

6: Severe disease at enrollment

60

TTCI (Time to Clinical Improvement);

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

Phase 4

[{"arm_notes": "", "treatment_id": 27, "treatment_name": "Adalimumab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]