To investigate whether treatment with Azvudine reduces the risk of severe illness or death in patients who are at a potential risk of progressing to severe COVID-19 infection.
The study is designed as a randomized, parallel, double-blind, placebo-controlled trial, in which all participants will be randomized to a test group or control group in a 1:1 ratio. The test group will be given Azvudine in combination with conventional therapy excluding anti-viral therapy and observed for efficacy. The control group will be given placebo in combination with conventional therapy excluding anti-viral therapy and observed for efficacy. Test Group will recruit 548 participants who will be given Azvudine + conventional therapy other than antiviral\*5 mg/day, oral, up to 7 days (1 mg/tablet). Control Group will recruit 548 who will be given Placebo + conventional therapy other than antiviral\* 5 tablets/day, oral, up to 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,096
Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGProportion of COVID-19-related critical illness or all-cause death within 28 days.
Proportion of COVID-19-related critical illness or all-cause death within 28 days. COVID-19-related critical illness is defined as: a patient with an SpO2 of 90% to 95% requiring high-flow oxygen inhalation with a fraction of inspired oxygen (FiO2) not less than 60% or requiring non-invasive ventilation with a FiO2 not less than 60%; or requiring mechanical ventilation or ECMO for organ support.
Time frame: 28 days
Incidence rates of Azvudine-related adverse events and serious adverse events
Incidence rates of Azvudine-related adverse events and serious adverse events
Time frame: 28 days
Duration of COVID-19-related symptoms
Duration of COVID-19-related symptoms
Time frame: 14 days
All-cause death
All-cause death
Time frame: 6 months
COVID-19 viral load in pharyngeal swabs
COVID-19 viral load in pharyngeal swabs
Time frame: D1, D3, D7
Days of hospitalization and ICU stay
Days of hospitalization and ICU stay
Time frame: 28 days
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