Phase IIb Study to Evaluate the Efficacy and Safety of Chloroquine Diphosphate in the Treatment of Patients With Comorbidities, Without Severe Acute Respiratory Syndrome, Under the New Coronavirus (SARS-CoV2): a Double-blind, Randomized, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Proportion of patients with onset of severe acute respiratory syndrome (SARS)
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to receive a 5-day CQ diphosphate tablets or placebo (tablet without active ingredient produced with the same physical characteristics).
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)
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
- •Suspected cases of COVID-19, due to clinical and radiological data, during the epidemic;
- •Adult aged 18 or over, at the time of inclusion
- •Not having severe acute respiratory syndrome (SARS), that is, not using mechanical ventilation or supplemental oxygen, peripheral oxygen saturation> 94% in room air, and having a respiratory rate below 24 incursions per minute.
- •Patients with comorbidities only, due to the increased risk of developing SARS
排除标准
- •Patients with chronic use of drugs known to prolong QTc interval.
研究组 & 干预措施
Intervention
CQ 450mg twice daily (3 tablets of 150mg, every 12 hours) on day 1, followed by CQ 450mg once daily (3 tablets of 150mg) from D2 to D5. Oral administration.
干预措施: Chloroquine Diphosphate (Drug)
Placebo
Placebo tables of equal characteristics and duration of treatment.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Proportion of patients with onset of severe acute respiratory syndrome (SARS)
时间窗: 7 days after randomization
Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.
次要结局
- Cumulative incidence of serious adverse events(During and after intervention, up to 28 days)
- Mortality rate(after randomization, up to 28 days)
- Number of participants in need of intensive care support(during and after intervention, up to 28 days)
- Incidence of cardiac disfunctions(after randomization, up to 120 days)
- Change in respiratory capacity(Day 120 after randomization)
- Viral concentration(After randomization, up to 7 days)
- Cumulative incidence of grade 3 and 4 adverse events(During and after intervention, up to 28 days)
- Proportion of patients with discontinued treatment(after randomization, up to 28 days)
- Incidence of cardiac lesions(after randomization, up to 120 days)