COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49435

Ye Feng/ Yang Zifeng/ Xu Xuyan/ Zhu Jun/ Jiang Lihong/ Zhang Yunhui/ Yuan Bing/ Chen Shi/ Fan Jie

yefeng@gird.cn

2020-02-18

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Aged>= 18, male or female, 2. Fever, axillary temperature > 37.3 degrees, 3. Consistent with the clinical diagnosis of COVID-19 mild, normal, severe case, 4. Patients who sign informed consent form freely and voluntarily.

1. Critical case with the following situation: i. Patients with respiratory failure and needing mechanical ventilation, ii. Patients with shock, iii. Patients with other organ failures and needing ICU monitoring and treatment, 2. Patients who have other respiratory tract infection, 3. Patients used Liu Shen Capsule within 1 month before screening, 4. Allergic constitution patients, who are allergic to the drugs used in this research, 5. Lactating or pregnant females, or urine pregnancy test was positive or did not agree to use contraception 3 months after the trial, 6. Immunodeficiency (such as a malignant tumor, solid organ or bone marrow transplant, aids, using immunosuppressive drugs within 3 months before screening), 7. Severe liver insufficiency (ALT or AST > 5ULN, or ALT or AST > 3ULN with BIL > 3ULN), Severe renal insufficiency (Ccr < 50ml/min, estimated by Scr), 8. Patients who do-not-resuscitate, 9. The researchers consider the patients are not suitable.

2

The First Affiliated Hospital of Guangzhou Medical University

18

100

China

No restriction on type of patients

0: No restriction on type of patients

40

Main symptom relief time;

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

Phase 0

[{"arm_notes": "", "treatment_id": 1336, "treatment_name": "Umifenovir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]