COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=50251

Pinhua Pan

pinhuapan668@126.com

2020-03-10

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Aged 18 to 75 years old, 2. The diagnosis of new-type coronavirus pneumonia was confirmed by RT-PCR or gene sequencing according to the Diagnosis and Treatment Scheme for Pneumonia of New Coronavirus Infection (Trial Version 6 and Updated) , and the clinical type was general (including severe high-risk factors) and severe, Note: Patients with common new type of coronavirus pneumonia (including severe high-risk factors): patients with common type with multiple lung multiple lesions, or pulmonary imaging shows that the lesion progresses significantly within 50% within 24 to 48 hours, 3. IL-6 is elevated (Roche chemiluminescence detection is recommended), 4. The patient voluntarily signed the informed consent.

1. Critical new pneumonia infection that meets one of the following conditions: respiratory failure occurs and requires mechanical ventilation, shock, combined organ failure requires ICU monitoring and treatment 2. Known allergies to Ixekizumab or antiviral drugs, 3. ALT / AST> 5 times ULN, neutrophils <0.5x10^9/L, Platelets less than 50x10^9/L, 4. Patients with impaired renal function: serum creatinine >=2 mg/dl (176 umol/l), 5. Combined with severe underlying diseases, the expected life cycle is less than 3 months, 6. Active hepatitis, patients with definite severe bacterial and fungal infections, tuberculosis infection, and HIV infection, 7. Clear diagnosis of malignant tumors such as lymphoproliferative diseases, 8. Known active Crohn's disease, 9. Pregnant or lactating women, 10. Participated in other interventional clinical trials in the past 3 months, 11. Other conditions that the researcher considers unsuitable.

2

Xiangya Hospital of Central South University

18

75

China

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

40

Lung CT;

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

Phase 0

[{"arm_notes": "", "treatment_id": 696, "treatment_name": "Ixekizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]