COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49428

Zhan Zhang

doctorzhang2003@163.com

2020-02-14

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Prevention

1. 18 years old <= age <= 60 years old when screening, not limited to men and women, 2. Who are in close contact with suspected cases, confirmed cases, and positive test of new coronavirus nucleic acid, and those who have not taken effective protection, that is, close contacts, 3. Study subjects are willing to be randomly assigned to any designated treatment group, 4. Must agree to not participate in another study of study drugs until day 24 of completion of the study. 5. Participants volunteered to participate in this study and signed informed consent.

1. The physician decides that participating in the trial is not in the best interest of the patient, or does not meet any conditions for safe follow-up in the protocol, 2. People with heart disease such as cardiac block, 3. People with eye diseases such as retina and cornea, 4. Severe liver disease (such as Child Pugh score >= C or AST > 5 times the upper limit), 5. Pregnancy or breastfeeding, or a positive pregnancy test during the pre-dose check, 6. Patients with known severe renal insufficiency (estimated glomerular filtration rate <= 30mL / min / 1.73m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis.

4

Renmin Hospital of Wuhan University

18

60

China

Close contacts to covid patients

N/A

320

Number of patients who have progressed to suspected or confirmed within 24 days of exposure to new coronavirus;

| Declared number of arm (4.0) differs from found arms (5.0)

Phase 0

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1336, "treatment_name": "Umifenovir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1336, "treatment_name": "Umifenovir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]