ACTRN12621000016831尚未招募2 期
A randomized, double-blind, placebo-controlled phase II trial to evaluate the efficacy of tasquinimod in reducing the time taken for a 2-point decrease in admission status.in adults with COVID-19
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Adult greater than or equal to 18 years, male or non-pregnant female at the time of enrolment.
- •2. Laboratory confirmed (RT-PCR) COVID-19 infection.
- •3. Able to give informed consent or by their legal representative for ICU patients who are unable to sign.
- •4. Must agree to comply with the study procedure.
- •5. On hospital admission with SPO2 less than or equal to 94% or needs mechanical ventilation or needs supplemental oxygen.
- •6. Must agree not to join any other clinical trial for COVID-19 throughout this study period [day 1 to day 28]
排除标准
- •1. Patients with severely deranged liver function (the hepatic transaminases more than 5x the upper limit of normal).
- •2. Severely deranged kidney function (with estimated glomerular filtration rate, eGFR less than or equal to 30ml/min/1.73m2 or patients on kidney replacement support).
- •3. Any plan of discharge in the next 72hours to a hospital that is not one of our study sites. 4. Breast-feeding or pregnant adult female.
- •5. History of allergy to the study drug. Good to note that women of child-bearing age will be advised and encouraged to adhere to safe and effective contraceptive measures.
研究者
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