COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49723

Baofeng Yang

yangbf@ems.hrbmu.edu.cn

2020-02-19

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

(1) Adult aged >=18 years and agrees to sign the informed consent, (2) Laboratory-confirmed 2019-nCoV infection by real-time RT-PCR, (3) Chest imaging (CT) confirmed lung damage: multiple small plaques and stromal changes in the lungs, which were obvious in the outer lung, or multiple ground-glass shadows and infiltration shadows in both lungs, the changes may not be present in mild patients, (4) Hospitalized patients with fever (axillary temperature >=37.0 degree C) or respiratory symptoms, (5) The interval between symptom onset and randomization was within 12 days, (6) Did not participate in other clinical researches within 3 months, (7) Do not participate other antiviral studies within 28 days of follow-up.

(1) The PI considers that the patient is not suitable to participate the study or the patient may be unsafe if he participate the study, (2) Patients with serious liver disease, grade C according to child-pugh, (3) Patients with severe renal impairment (glomerular filtration rate <=30mL/min/1.73m2) or who have received continuous renal replacement therapy, hemodialysis or peritoneal dialysis, (4) Patients with severe anemia, Hgb < 60g/L. (5) Pregnant women or women with pregnancy test positive or breastfeeding women, (6) Patients with allergy history of Triazavirin or its components, (7) Confused to sign the informed consent, (8) Patients may be transferred to another hospital within 72h, (9) Received any experimental treatment for novel coronavirus infection within 30 days prior to screening.

2

Health commission of Heilongjiang province

18

None

China

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

240

Time to Clinical recovery;

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

Phase 3

[{"arm_notes": "", "treatment_id": 1315, "treatment_name": "Triazavirin", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]