Informations générales (source: ClinicalTrials.gov)
COVID 19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease Upon Hydroxychloroquine and Azithromycin Therapy in French Cancer Patients
Interventional
Phase 2
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
avril 2020
avril 2022
13 septembre 2025
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).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Lisa DEROSA, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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.
- 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.
- 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.