A Pilot, Randomized, Open-label Trial to Determine the Feasibility, Safety, Efficacy, and Pharmacokinetics of Nebulized HCQ01 for the Treatment of Patients With COVID-19 and Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Proportion of participants who improve by at least one level lower on the 11-point World Health Organization Ordinal Scale for Clinical Improvement (WHO-OSCI), where patients are scored on a scale of 0-10 with 0 being uninfected and 10 being dead .
研究概览
简要总结
This is a pilot, randomized, single-center, parallel group, open-label controlled study to evaluate the feasibility, safety, efficacy, and pharmacokinetics of nebulized HCQ01 plus Standard of Care (SOC) versus SOC alone in hospitalized cancer patients with COVID-19. King Hussein Cancer Center (KHCC) is the study sponsor, and the study will be conducted at KHCC COVID-19 wards.
Approximately 28 cancer patients, ≥18 years of age with a confirmed SARS-CoV-2 infection, will be enrolled and randomized 1:1 to the treatment and control arms where they will receive ten doses of Hydroxychloroquine solution via nebulizer in addition to SOC or the control arm where treatment will follow KHCC SOC.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
First Arm (Hydroxychloroquine sulfate, 5 days)
Participants will receive continued standard of care therapy (SOC) for COVID-19 together with 2 ml HCQ01 (12.5 mg/ml) twice a day for 5 consecutive days.
干预措施: HCQ01 (Drug)
First Arm (Hydroxychloroquine sulfate, 5 days)
Participants will receive continued standard of care therapy (SOC) for COVID-19 together with 2 ml HCQ01 (12.5 mg/ml) twice a day for 5 consecutive days.
干预措施: standard of care (SOC) for COVID-19 (Drug)
Second Arm (Continued Standard of Care (SOC) Therapy)
Participants will receive continued standard of care therapy for COVID-19
干预措施: standard of care (SOC) for COVID-19 (Drug)
结局指标
主要结局
Proportion of participants who improve by at least one level lower on the 11-point World Health Organization Ordinal Scale for Clinical Improvement (WHO-OSCI), where patients are scored on a scale of 0-10 with 0 being uninfected and 10 being dead .
时间窗: Time Frame: Day 14
次要结局
- Oxygenation free days(Day 14, 28)
- Ventilator free days(Day 14, 28)
- Incidence & duration of new oxygen use(Day 14, 28)
- Cardiac Arrhythmia - Polymorphic Ventricular Tachycardia(Up to day 28)
- Cardiac Arrhythmia - Ventricular Tachycardia(Up to day 28)
- Cardiac Arrhythmia - Lengthening QTc(Up to day 28)
- Proportion of participants who improve by at least one level lower on the 11-point WHO-OSCI(Days 5, 28)
- All-cause mortality(Day 28)
- Rate of Transfer to the Intensive Care Unit(Up to day 28)
- Time to Clinical Improvement(Up to day 28)
- Duration of hospitalization(Up to 28 days)
- Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hrs(Up to 28 days)
- Status of discharged or not requiring supplemental oxygen(Day 14, 28)
- Rates of Intensive Care Unit mortality(Day 14, 28)
- Intensive Care length of stay(Up to day 28)
- Change in condition measured using the 11-point WHO-OSCI(Days 5, 14, 28)
- Hydroxychloroquine (HCQ) concentration in plasma versus time profiles(Day 1 pre-dose (time 0) and +2, +5, +10, +15, +20, +25, and +30 minutes after dose, and also +1, +2, +3, +4 and +6 hours post-dose completion)
- Change from Baseline Oxygenation as determined by the SpO2 / FiO2 ratio(Day 5 of treatment)
- Treatment-related adverse events of HCQ(Up to day 28)
- Incidence and duration of new mechanical ventilation use(Day 14, 28)
研究者
Feras Hawari
Consultant in Pulmonary and Critical Care
King Hussein Cancer Center