Official Title
COVID 19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease Upon Hydroxychloroquine and Azithromycin Therapy in French Cancer Patients
Brief Summary

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).

Recruiting
Cancer & COVID 19

Drug: Hydroxychloroquine
Hydroxychloroquine 200 mg 3 times a day for 10 days
Cohort 1
Cohort 4

Drug: Azithromycin
Azithromycin 500 mg on day 1 followed by 250 mg/day for 4 days
Cohort 1

Eligibility Criteria

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.

Exclusion Criteria:

- 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
France
Contacts

Lisa DEROSA, MD
0142114211 +33
lisa.derosa@gustaveroussy.fr

Stefan MICHIELS, MD
0142114211 +33
Stefan.michiels@gustaveroussy.fr

Gustave Roussy, Cancer Campus, Grand Paris
NCT Number
MeSH Terms
Azithromycin
Hydroxychloroquine