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).

Unknown status
Cancer & COVID 19

Drug: Hydroxychloroquine

Hydroxychloroquine 200 mg 3 times a day for 10 days

Drug: Azithromycin

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

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 ~ Maximum: N/A
Countries
France
Locations

Gustave Roussy
Villejuif, Val De Marne, France

Investigator: Lisa DEROSA, MD
Contact: 0142114211
lisa.derosa@gustaveroussy.fr

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
COVID-19
Azithromycin
Hydroxychloroquine