Piclidenoson for Treatment of COVID-19 - A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 6
- 主要终点
- Proportion of subjects alive and free of respiratory failure
研究概览
简要总结
Patients with documented moderate COVID-19 infection will be randomized 1:1 to receive piclidenoson 2 mg Q12H orally with standard supportive care (SSC - intervention arm) or placebo orally with SSC (control arm) for up to 28 days.
详细描述
This is a randomized, double-blind, placebo-controlled, pilot trial of piclidenoson 2 mg Q12H added to SSC, compared to placebo plus SSC, in a population of hospitalized subjects with "Moderate" or "Severe" COVID-19 per U.S. National Institutes of Health (NIH) Coronavirus Disease 2019 (COVID-19) Treatment Guidelines (2020). Subjects will be randomized according to a 1:1 ratio to one of the trial arms, and treated for up to 28 days, at the discretion of the Investigator. Piclidenoson 2 mg and placebo are supplied as matching tablets for oral administration.
Following initial diagnosis of COVID-19, and after having provided informed consent, subjects will be randomized according to 1:1 ratio to one of the trial arms on Day 0. SSC will be implemented and documented for all subjects, and maintained throughout the treatment period.
Vital signs (temperature, blood pressure, pulse rate per minute, respiratory rate per minute, oxygen saturation (SpO2), and PaO2/FiO2) of subjects will be monitored twice daily according to SSC. Parameters of clinical, respiratory, and vital status will be collected daily. Viral shedding will be assessed on a regular basis. Samples for pharmacokinetic (PK) analysis will be collected on Day 4.
Efficacy of piclidenoson will be assessed by clinical, respiratory, and virologic parameters. Safety and tolerability of piclidenoson will be assessed by adverse event (AE) monitoring, vital signs assessment, electrocardiograms (ECGs), and clinical laboratory tests (complete blood count (CBC) and extended chemistry panel). Adverse events will be graded by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Piclidenoson
Piclidenoson 2 mg every 12 hours orally added to standard of care
干预措施: Piclidenoson (Drug)
Placebo
Placebo every 12 hours orally added to standard of care
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects alive and free of respiratory failure
时间窗: 29 days
Proportion of subjects alive and free of respiratory failure (defined as need for non-invasive or invasive mechanical ventilation, high-flow oxygen, or extracorporeal membrane oxygenation) at Day 29
Treatment-emergent adverse events (AEs)
时间窗: 29 days
Proportion of patients experiencing AEs
Proportion of subjects discharged home alive
时间窗: 29 days
Proportion of subjects alive and discharged to home without need for supplemental oxygen at Day 29
次要结局
- Ventilator-free days(29 days)
- Treatment-emergent serious AEs (SAEs)(29 days)
- Duration of ICU stay(29 days)
- Duration of need for supplemental oxygen(29 days)
- Incidence of meeting safety-related stopping rules(29 days)
- Clinical status(29 days)
- Time to improvement(29 days)
- Incidence of mechanical ventilation(29 days)
- Time to virus negativity(29 days)
- SARS-CoV-2 viral load(29 days)
- Serum cytokine levels(29 days)
- Incidence of Intensive Care Unit (ICU) admission(29 days)
- Time to hospital discharge(29 days)
- AEs leading to withdrawal(29 days)
- Pharmacokinetics of piclidenoson in this patient population(5 days)
- Treatment-emergent abnormalities in clinical laboratory parameters or electrocardiograms (ECGs)(29 days)