Clearing the Fog: Is HCQ Effective in Reducing COVID-19 progression-a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UNICEF
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Number of Participants With Progression
研究概览
简要总结
Brief Summary: Purpose of this study is to evaluate efficacy of hydroxychloroquine (HCQ) in reducing progression of Corona Virus Disease 2019 (COVID - 19) and achieving viral clearance.
Condition or disease :I COVID-19 ntervention/treatment :Drug: Hydroxychloroquine Sulfate Phase: Phase III
详细描述
This study explores efficacy of HCQ (400mg BD on D0 and 200mg BD D1-D5) in reducing progression of Mild Covid-19 patients and decreasing viral load.
Participants of study will be randomized 2:1 to receive either Active drug or standard of care (SOC) treatment respectively. We aim to demonstrate reduced COVID-19 progression and early viral clearance in individuals on HCQ therapy.
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
- None
盲法说明
Neither patients, nor investigators, nor statisticians were masked to treatment assignment. Lab staff who performed sampling for PCR, basic blood tests and other routine measurement were unaware of treatment information.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild Corona virus disease (COVID-19)
- •PCR confirmed infection
- •Hospital admitted patients
排除标准
- •Moderate, severe and critical COVID-19
- •day 0 CRP greater than 6mg/dl, ALC < 1000 or evidence of infiltrates on X-ray chest
- •comorbidity with life expectancy less than 6 months
- •Contraindications to HCQ therapy
研究组 & 干预措施
HCQ arm
Patients selected in experimental arm will be given Tab HCQ (400mg BD on D0 followed by 200mg BD D1-D5) in addition to supportive treatment
干预措施: HCQ (Drug)
结局指标
主要结局
Number of Participants With Progression
时间窗: 5 days
After start of treatment, development of fever \> 101 F for \> 72 hours, shortness of breath by minimal exertion (10-Step walk test), derangement of basic lab parameters (ALC \< 1000 or raised CRP) or appearance of infiltrates on CXR during course of treatment was labeled as progression irrespective of PCR status
次要结局
- Viral Clearance(14 days)
研究者
sultan mehmood kamran
Classified Medical specialist
UNICEF