COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04273581

Jinglin Xia, MD

xiajinglin@fudan.edu.cn

2020-02-18

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: age ≥18 years; the laboratory (rt-pcr) confirmed the diagnosis of severe patients infected with covid-19 (refer to the fifth edition of the chinese diagnosis and treatment guideline for trial); the diagnosis of new coronavirus pneumonia was confirmed, and any of the following: 1) respiratory distress, breathing ≥30 beats / min; 2) in the resting state, the oxygen saturation is ≤93%; 3) arterial blood oxygen partial pressure / oxygen concentration ≤300mmhg the diagnosis is less than or equal to 12 days;

severe liver disease (such as child pugh score ≥ c, ast> 5 times the upper limit); severe renal dysfunction (the glomerulus is 30ml / min / 1.73m2 or less) pregnancy or breastfeeding or positive pregnancy test; in the 30 days before the screening assessment, have taken any experimental treatment drugs for covid-19 (including off-label, informed consent use or trial-related); those with a history of thromboembolism, except for those caused by picc.

2

First Affiliated Hospital of Wenzhou Medical University

18

None

None

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

40

Time to Clinical Improvement (TTCI)

None

Phase 2

[{"arm_notes": "", "treatment_id": 1282, "treatment_name": "Thalidomide", "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"}]