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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 7
- 主要终点
- Proportion of patients hospitalized during the study through day 28
研究概览
简要总结
Phase III, single-center with co-participating units, randomized, double-blind, parallel, placebo-controlled clinical study
详细描述
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;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who present the following characteristics will be included in this study:
- •Age ≥18 years, regardless of gender;
- •Fluorescence RT-PCR test result of respiratory or blood samples must be positive for COVID-19, or viral gene sequencing of respiratory tract samples must be highly homologous to COVID-19; Individuals with COVID-19 must meet the diagnostic criteria in the "latest version of clinical guidelines for COVID-19" issued by the World Health Organization (WHO) on June 4, 2020;
- •Symptomatic patients who meet the case definition for COVID-19, according to WHO, without evidence of bacterial pneumonia or hypoxia (Sat O2 < 95%) P. [score 1-3];
- •Voluntary participation and signing of the informed consent form.
排除标准
- •Individuals who present one or more of the following characteristics will not be eligible to participate in this study:
- •Know or suspect that you are allergic to any of the components of AZVUDINE tablets (inactive ingredients: microcrystalline cellulose, lactose hydrate, polyvinylpyrrolidone K30, croscarmellose sodium, magnesium stearate);
- •Individual presenting shortness of breath and Sat O2 < 95%; or any other symptom requiring treatment through hospital admission;
- •Patients with liver disease (total bilirubin ≥2mg/dL, ALT/TGP e AST/TGO ≥5 times above normal limit);
- •Pactients with a history of known liver disease (cirrhosis with ChildPugh classification B and C);
- •Patients with a history of renal insufficiency (glomerular filtration rate < 60mL/min/1,73m2);
- •Patients with history of congestive heart failure (NYHA ¾ grade), untreated symptomatic arrhythmias ormyocardial infarction within 6 months;
- •Individuals with malabsorption syndrome, or other conditions affecting gastrointestinal absorption, and circumstances in which patients require intravenous nutrition, or cannot take medications orally or nasogastrically;
- •Total neutrophil count <750 cells/L;
研究组 & 干预措施
AZVUDINE
Experimental:
AZVUDINE 1mg tablet
Interventions:
AZVUDINE 1mg tablet, 5 tablets QD + standard treatment, for up to 14 days
干预措施: AZVUDINE (Drug)
AZVUDINE placebo
Control:
AZVUDINE placebo
Intervention:
AZVUDINE placebo tablet, 5 tablets QD + standard treatment, for up to 14 days
干预措施: AZVUDINE placebo (Drug)
结局指标
主要结局
Proportion of patients hospitalized during the study through day 28
时间窗: Day 14 to Day 30
WHO clinical progression ordinal scale (Jun/2020), Score 4 to 10.Health Organization Ordinal Clinical Progression Scale (WHO, Jun/2020; scale 0 \[asymptomatic\] to 10 \[death\]), with score 4 to 7.
Proportion of participants with a clinical outcome of CURE during the study;
时间窗: Day 14 to Day 30
The clinical outcome of cure is defined in this protocol as the absence of viral RNA in samples collected and clinical conditions for outpatient discharge.
次要结局
- Improvement in clinical status in at least one category compared to screening(Day 14 to Day 30)
- Severity and duration of symptoms: fever, cough, fatigue or tiredness, breathlessness, myalgia, nasal congestion or runny nose, sore throat, headache, chills, nausea, vomiting, anosmia, ageusia.(Day 1 to Day 14)
- Changes in kidney function(Day 1 to Day 30)
- Changes in liver function(Day 1 to Day 30)
- Time of use of AZVUDINE until the second negative conversion of RT-PCR(Day 1 to Day 14)
- Assessment of liver function biochemical markers (AST/TGO, ALT/TGP, ALP, GGT, BIL total, and direct BIL)(Day 1 to Day 60)
- Evaluation of SARS-CoV-2 viral load negative conversion time by RT-PCR between AZVUDINE group (FNC) and control group(Day 1 to Day 28)
- Occurrence of drug interactions(Day 1 to Day 14)
- All-cause mortality rate during the study(Day 1 to Day 60)
- Frequency and intensity of adverse events, unexpected adverse events, and serious adverse events(Day 1 to Day 30)
- Proportion of comorbidity-related worsening [Obesity, diabetes, alcoholism, smoking, lung disease](Day 1 to Day 30)
- hospitalization for all causes occurring in post-treatment period(Day 1 to Day 60)
- To assess the tolerability of using AZVUDINE (FNC) at 5mg/day(Day 1 to Day 14)