Single-center, Phase II, Randomized Double-blind, Placebo-controlled Study of Hydroxychloroquine Compared to Placebo as Treatment for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Clinical improvement on the Ordinal Scale for Clinical Improvement (OSCI)
研究概览
简要总结
This study is being done to see if hydroxychloroquine is an effective treatment for COVID-19.
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
- Double (Participant, Investigator)
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
- •Age 18 years and older
- •Subjects must have a documented positive test for the SARS-CoV-2 infection within 7 days of randomization
- •Subject must be hospitalized within 72 hours of randomization
- •Subjects must be receiving standard of care for SARS-CoV-2
- •Subject/Legally Authorized Representative (LAR) must have the ability to understand and give informed consent
- •Subject must be able to take and absorb hydroxychloroquine at the discretion of the investigator
排除标准
- •Prior receipt of hydroxychloroquine for treatment or prophylaxis of SARS-CoV-2 or patient is taking hydroxychloroquine for other approved indications (e.g., lupus, rheumatoid arthritis)
- •No documented SARS-CoV-2 infection
- •Mechanical ventilation
- •Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives Preexisting retinopathy documented in medical history
- •Pregnancy or Breastfeeding
- •Concurrent use of any other quinine derivative (chloroquine, mefloquine) or rifamycins (rifampin, rifabutin)
- •Antiarrhythmic medications (amiodarone, sotalol, dofetilide, procainamide, quinidine, flecainide)
- •History of glucose-6-phosphate dehydrogenase deficiency
- •Pre-treatment corrected QT interval (QTc) >500 milliseconds
- •Pressor requirement to maintain blood pressure
- •Alanine aminotransferase (ALT) and/or asparate aminotransferase (AST) level > 5X upper limit of normal
- •Creatinine clearance <30 mL/min or requirement of dialysis or continuous venovenous hemofiltration
- •Concomitant participation in a therapeutic trial for SARS-CoV-2 or receiving any experimental treatment for SARS-CoV-2 within 7 days of randomization
- •Any condition that in the opinion of the principal investigator would prevent participation in the trial or would interfere with the trial endpoints
研究组 & 干预措施
Arm A - hydroxycholoroquine
Participants will receive hydroxycholoroquine (200-mg tablets) 2 tablets orally q12h for 2 doses on day 1 (load), followed by 1 tablet orally q12h for days 2-5.
干预措施: Hydroxychloroquine (Drug)
Arm B - placebo
Participants will receive placebo
干预措施: Placebo (Other)
结局指标
主要结局
Clinical improvement on the Ordinal Scale for Clinical Improvement (OSCI)
时间窗: 14 days
Clinical improvement is defined as a composite endpoint of a two-point clinical improvement on the Ordinal Scale for Clinical Improvement (OSCI). The OSCI is an ordinal scale of 9 severity levels (from 0 to 8) for COVID-19
Number of participants requiring mechanical ventilation for respiratory failure
时间窗: 14 days
Clinical improvement is defined as no mechanical ventilation for respiratory failure attributed to SARS-CoV-2 within 14 days of randomization.
次要结局
未报告次要终点