COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49738

Hongliang He

44271370@qq.com

2020-02-19

Recruiting

RCT

Randomized

Parallel

Not reported

single-center

Treatment

1. The patients who were diagnosed with the common type of NCP (including severe risk factors) and severe cases of new coronavirus pneumonia, 2. Aged 18 to 85 years, 3. IL-1ß elevated (using Elisa method, using the same company kit), 4. Patients or authorized family members volunteered to participate in this study and signed informed consent, Definition of Novel Coronavirus Pneumonia (NCP) clinical cases: 1. Regular patients with NCP (including severe risk factors): patients with dual pulmonary lesions based on common NCP clinical symptoms accompanied by fever or no fever, 2. Critical NCP patient: Refer to the New Coronavirus Pneumonia Diagnosis and Treatment Plan (Fifth Edition) formulated by the National Health Commission.

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 life<1 week, 5. Definite diagnosis of asthma-related diseases, 6. Long-term oral anti-rejection or immunomodulatory drugs, 7. Hypersensitivity to tocilizumab or any excipients, 8. Patients with active pulmonary tuberculosis, with definite bacterial and fungal infections.

2

The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital)

18

85

China

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

60

cure rate;

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

Phase 4

[{"arm_notes": "", "treatment_id": 1309, "treatment_name": "Tranilast", "treatment_type": "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"}]