COVID 19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease Upon Hydroxychloroquine and Azithromycin Therapy in French Cancer Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin
研究概览
简要总结
To determine the prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients (Part A).
To evaluate the Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (Part B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •All types of locally advanced and metastatic malignancy
- •Male/female participants
- •Age>18 y.o.
- •Signed informed consent for participation in the study
- •No restriction on Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) Performance Status
- •Subject should not have received a prior systemic anti-viral treatment for Covid19 disease.
排除标准
- •Patients with known hypersensitivity to hydroxychloroquine or chloroquine, azithromycin, erythromycin, or any other macrolide, ketolide or any of the excipients of the hydroxychloroquine and/or azithromycin-based specialty used.
- •Severe hepatic impairment and patients with severe cholestasis.
- •Patients with renal insufficiency with creatinine clearance < 40 mL/min.
- •Combinations of drugs contraindicated in accordance with the approvals of the specialties used.
- •Patients currently treated with Tamoxifen
- •Patients already treated by hydroxychloroquine or azithromycin for Covid19 disease or currently treated with other antiviral drugs against coronavirus.
- •Patients with known contra-indication to treatment with the study drug, including retinopathy, G6PD deficiency, QT prolongation and severe hepato-cellular insufficiency.
- •Patients post allogeneic hematopoietic stem cell transplantation are eligible to the Part B treatments but the potential toxic effects of hydroxychloroquin and azithromycin on hematopoietic stem cells should be taken into consideration by prescribers.
- •Pregnant or breastfeeding women. Women of childbearing potential (WOCBP, as defined in appendix 2) should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
研究组 & 干预措施
Cohort 1
Advanced Cancer Patients with SARS-CoV-2 positive test & Covid19 symptoms
干预措施: Hydroxychloroquine (Drug)
Cohort 1
Advanced Cancer Patients with SARS-CoV-2 positive test & Covid19 symptoms
干预措施: Azithromycin (Drug)
Cohort 4
Advanced Cancer Patients with SARS-CoV-2 positive test AND chest CT-scan compatible with Covid19 disease & no Covid19 symptoms & Pretreated or with frail conditions following the HCSP definition
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin
时间窗: Up to 12 months
Prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients
时间窗: Up to 3 months
次要结局
未报告次要终点