Cure COVID: A Prospective, Controlled, Randomized Study to Compare the Efficacy of GNS561 Versus Standard of Care in Patients With SARS-CoV-2 (COVID-19) Infection
试验速览
- 阶段
- 2 期
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- number and proportion of participants, per randomized group, with a loss of one or two grades of National Early Warning Score (NEWS2) score at day-7 compared to baseline
研究概览
简要总结
This is a multicenter, open-label, controlled, randomized phase 2 study designed to evaluate the safety and efficacy profile of GNS561 in patients with COVID-19.
详细描述
Patients will be treated either with oral GNS561 plus standard of care or only standard of care. All patients in experimental arm will be treated for ten days. Study drug will be provided as oral capsules containing 200 mg of GNS561. Patients will be followed-up during hospitalization and after discharge.
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
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
- •Documented diagnosis of COVID-19 (diagnostic test performed in a certified laboratory).
- •Clinical status: Hospitalized for moderate COVID-19 with News2 score between 5 and 6
排除标准
- •Patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (quinine, tafenoquine, hydroxychloroquine, mefloquine).
- •History of QT prolongation (QTc ≥ 500 ms) or QTc ≥ 500msec at screening or bradycardia < 50/mn
- •Current use of loop diuretics and potassium supplementation or documented history of hypokalemia or hypokalemia < 3.5mmol/l at screening
- •Prior allogeneic bone marrow transplantation or solid organ transplant in the past.
- •Pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs.
研究组 & 干预措施
GNS561 plus standard of care
All patients in this Arm will be treated with 200mg oral capsule of GNS561, once a day, for 10 days and with any necessary measures based on the patient's condition and at the investigator's discretion and routine practices.
干预措施: GNS561 (Drug)
结局指标
主要结局
number and proportion of participants, per randomized group, with a loss of one or two grades of National Early Warning Score (NEWS2) score at day-7 compared to baseline
时间窗: 7 days
severe stage at baseline to medium or low stage at day-7 or medium stage at baseline to low stage at day-7
次要结局
- the rate of nasopharyngeal swab negativation at D7, D14 and D28(7 days, 14 days and 28 days)
- the 28-day survival rate(28 days)
- the rate of intensive care unit admission(14 days)