COVID-19 Clinical Trial
Official title:
Evaluation of the Safety and Clinical Efficacy of AZVUDINE: Randomized, Double-blind, Placebo-controlled Study in Mild Stage Patients Infected With the SARS-CoV-2 Virus
Phase III, single-center with co-participating units, randomized, double-blind, parallel, placebo-controlled clinical study
Hypothesis: AZVUDINE has a therapeutic potential and safety profile for the treatment of patients infected with SARS-CoV-2. Goals: Main goal: To evaluate the efficacy and safety of AZVUDINE (FNC) in patients infected with SARS-COV-2, in a mild stage; Specific objective: To assess the clinical outcome of mild-stage SARS-CoV-2 infected participants treated with AZVUDINE (FNC) versus placebo Statistical planning: Statistical description: all statistical tests are performed by bilateral testing. A significance level of 5% will be adopted. Baseline analysis: including subject distribution, data demographics, and baseline analysis. ;
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