Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease in French Cancer Patients

Study Overview
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Brief Summary
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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).

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

Conditions
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Cancer & COVID 19

Intervention / Treatment
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* Drug: Hydroxychloroquine
* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Advanced Cancer Patients with SARS-CoV-2 positive test & Covid19 symptoms | Drug: Hydroxychloroquine<br>* Hydroxychloroquine 200 mg 3 times a day for 10 days<br>Drug: Azithromycin<br>* Azithromycin 500 mg on day 1 followed by 250 mg/day for 4 days<br>|
| No Intervention: Cohort 2<br>Advanced Cancer Patients with SARS-CoV-2 negative test & Covid19 symptoms. Patients with a chest CT-scan compatible with Covid19 disease shall be treated in part B. | |
| No Intervention: Cohort 3<br>Advanced Cancer Patients with SARS-CoV-2 positive or negative test & no Covid19 symptoms | |
| Experimental: Cohort 4<br>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 | Drug: Hydroxychloroquine<br>* Hydroxychloroquine 200 mg 3 times a day for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients |  | Up to 3 months | 
| Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin |  | Up to 12 months |