Randomised, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Evaluation of the efficacy of hydroxychloroquine and azithromyncine on the viral load drop at day 5.
研究概览
简要总结
The primary objective of this phase 2, multicentric, placebo-controlled double-blind, randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and azithromycine on the viral load drop at day 5 among patients with COVID-19 and hematological malignancies.
详细描述
The study will evaluate the effect of the combination of hydroxychloroquine and azithromycine versus placebo among 114 patients with COVID-19 and hematologic malignancy.
After randomization in 1:1 ratio, patients will receive either the study treatment or placebo :
- Patients enrolled in the experimental arm will receive hydroxychloroquine (200mgx3 tablets per day during 10 days) and azithromycine (500 mg at day 1 then 250mg per day during 4 days)
- Patients enrolled in the control arm will receive a placebo of hydroxychloroquine (3 tablets per day during 10 days) and a placebo of azithromycine (2 capsules at day 1, then 1 capsule per day during 4 days)
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
- •18 years or older patients
- •Patient with hematologic malignancy who received or not hematopoietic stem cell transplantation
- •Non severe Covid-19 disease
- •PCR-confirmed COVID-19 disease by a nasopharyngeal swab
- •Life-expectancy related to the hematologic malignancy of at least 1 month
- •Men or women of child-bearing potential accepting to use effective contraception during and until 8 months after the end of the study treatment
排除标准
- •Patients with severe form of COVID-19 infection defined as the presence of crackles observed during clinical exam, associated with less than 94% oxygen saturation or patients with respiratory insufficiency on oxygen therapy or mechanical ventilation
- •Previous treatment with hydroxychloroquine or azithromycine for Covid-19 infection
- •QTc interval greater than 480 ms
- •Hypersensibility to hydroxychloroquine or azithromycine
- •Retinopathy
- •TGO or TGP geater than 5 x the normal upper limit
- •Creatinine clearance lower than 30 ml/min
- •Concomitant treatment that may lead to prolongation of the QT space
- •Concomitant treatment with dihydroergotamine, ergotamine, cisapride or colchicine
- •Known G6PD deficiency
研究组 & 干预措施
Treatment arm
Patients enrolled in the experimental arm will receive hydroxychloroquine (200mgx3 tablets per day during 10 days) and azithromycine (500 mg at day 1 (2 capsules taken at the same time) then 250mg per day (1 capsule per day) during 4 days).
干预措施: Hydroxychloroquine Sulfate 200 MG [Plaquenil] (Drug)
Treatment arm
Patients enrolled in the experimental arm will receive hydroxychloroquine (200mgx3 tablets per day during 10 days) and azithromycine (500 mg at day 1 (2 capsules taken at the same time) then 250mg per day (1 capsule per day) during 4 days).
干预措施: Azithromycin 250 MG Oral Capsule (Drug)
Control arm
Patients enrolled in the control arm will receive a placebo of hydroxychloroquine (3 tablets per day during 10 days) and a placebo of azithromycine (2 capsules taken at the same time at day 1, then 1 capsule per day during 4 days)
干预措施: Placebo oral tablet (Drug)
Control arm
Patients enrolled in the control arm will receive a placebo of hydroxychloroquine (3 tablets per day during 10 days) and a placebo of azithromycine (2 capsules taken at the same time at day 1, then 1 capsule per day during 4 days)
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Evaluation of the efficacy of hydroxychloroquine and azithromyncine on the viral load drop at day 5.
时间窗: 5 days of treatment
Locally evaluated rate of viral response. Favorable response is defined as (1) complete response : negative PCR (absence of detectable signal with a minimum of 40 cycles) or (2) major response : detectable signal but with an increased number of cycles \> or egal to 10 compared to initial PCR. Response failure is defined as (1) minor response : detectable signal but with an increased number of cycles \< 10 compared to initial PCR or (2) stabilisation or worsening of the viral load.
次要结局
- Dosage of residual concentration of azithromycine and hydroxychloroquine.(at day 5 and day 10)
- Mortality(up to 1 and 3 months)
- Evaluation of the seroconversion(at inclusion, day 10, day 30 and day 90 after treatment)
- Impact of the study treatment on the treatment of the hematological disease(up to 3 months)
- Clinical evolution(up to 3 months)
- Proportion of patients progressing to a severe form(up to 3 months)
- Evaluation of viral load drop(at day 10)
- Tolerance of study treatment(up to 3 months)
- NK immunological study(at day 10 and day 30 after treatment)
- Hospitalisation duration(up to 3 months)
- Monitoring of the QT space(at inclusion, day 2, day 5, day 10)
- T immunological study(at day 10 and day 30 after treatment)