COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=53368

Zhang Fujie

treatment@chinaaids.cn

2020-05-09

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

(1) age =18 years old, gender not limited, (2) Laboratory (RT-PCR) confirmed COVID-19, (3) the time from the first positive nucleic acid test to randomization does not exceed more than 4 days, (4) informed consent has been signed.

(1) known or suspected allergies to the components of azivudine tablets, (2) according to the latest version of the National Health and Medical Commission Diagnostic criteria of COVID-19, ?patients with severe novel coronavirus pneumonia was confirmed, (3) severe liver disease (TBIL>=2 times normal upper limit, ALTAST>=5 times normal upper limit), (4) subjects with severe renal insufficiency (glomerular filtration rate =60 mL/min/1.73 m2) or undergoing continuous renal replacement therapy, hemodialysis or peritoneal dialysis, (5) subjects with complication of malabsorption syndrome or any other condition affecting gastrointestinal absorption, requiring intravenous nutrition or not being able to take drugs orally, (6) subjectsis currently receiving anti-hiv treatment, (7)women who are breast-feeding during pregnancy or have a family plan during the trial period and within 6 months after the end of the trial, (8) participating in other clinical trials or using experimental drugs, except traditional Chinese medicine, (9) Other conditions that not appropriate to be enrolled into this study based on investigator's advise.

2

Beijing Ditan Hospital affiliated to Capital Medical University

18

None

China

No restriction on type of patients

0: No restriction on type of patients

342

On day 7 and 14; Change (reduction) in viral load from baseline;

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

Not reported

[{"arm_notes": "", "treatment_id": 167, "treatment_name": "Azvudine", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]