COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=50973

Zhaofen Lin

linzhaofen@sina.com

2020-03-14

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Aged between 18 and 75 years, 2. In accordance with NCP criteria for severe and critical illness. Combined with the following epidemiological history, clinical manifestations, and pathogenic examinations to make a comprehensive judgment, 3. Will not participate in other drug clinical trials since the first day of Ulinastatin Injection admission, 4. Will sign written informed consent. Adolescents or patients who cannot sign informed consent must obtain informed consent from the guardian.

1. With contraindications of Ulinastatin Injection, 2. Pregnant or lactating women, 3. Patients taking other urinary trypsin inhibitors, 4. Not suitable to participate in the clinical trial by investigator's judgement.

2

Shanghai Changzheng Hospital

18

75

China

Severe disease at enrollment

6: Severe disease at enrollment

100

blood gas;SOFA score;

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

Phase 4

[{"arm_notes": "", "treatment_id": 1328, "treatment_name": "Ulinastatin", "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"}]