COVID-19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease upon Hydroxychloroquine and Azithromycin Therapy in French Cancer patients
- Conditions
- Patients eligible for, or under, or recently treated by chemotherapy (CT) and/or immune-checkpoint blockade (ICB) for the treatment of solid tumors or hematological malignancies.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-001250-21-FR
- Lead Sponsor
- GUSTAVE ROUSSY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
•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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
•Patients with known allergy to hydroxychloroquine or chloroquine,
•Patients with known allergy to azithromycine, erythromycine, or all antibiotics belonging to the macrolide family.
•Patients currently treated with Tamoxifen
•Patients with known contra-indication to treatment with the study drug, including retinopathy, G6PD deficiency, QT prolongation and severe hepato-cellular insufficiency.
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method