COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49831

Ke Hu

hukejx@163.com

2020-02-22

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. aged 18-70 years male or female, 2. 2019 new coronavirus nucleic acid test positive, 3. meet the national diagnosis criteria, 4. subjects onset within 8 days (severe cases can be delayed to 14 days), 5. subjects or agency personnel agree to sign the informed consent, 6. subjects who can take oral medication or who receive oral medication, 7. subjects agree to collect clinical samples, 8. female subjects of child-bearing age are not pregnant and agree to take effective contraceptive measures within 7 days of the last oral medication to ensure that they will not pregnant, 9. men agree not to have sex with women for seven days after taking their last oral medication.

1. severe vomiting and difficulty in taking oral medication or absorbing in oral medication, 2. pregnant and nursing women, 3. subjects received lopinavir/ridonavir, ribavirin, monoclonal antibodies and other specific antiviral drugs in the week prior to admission, 4. subjects exist respiratory failure requiring mechanical ventilation, 5. subjects of shock, 6. subjects combined with other organ failure requires intensive care unit, 7. subjects with no clinical expectation of survival and only give end-of-life care, or those in a deep coma who did not respond to supportive treatment within three hours of admission.

2

Renmin Hospital of Wuhan University

18

70

China

No restriction on type of patients

0: No restriction on type of patients

200

The days from positive to negative for viral nucleic acid testing;

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

Phase 3

[{"arm_notes": "", "treatment_id": 724, "treatment_name": "Leflunomide", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]