Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease in French Cancer Patients
NCT ID: NCT04341207
Last Updated: 2020-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
1000 participants
INTERVENTIONAL
2020-04-03
2022-04-30
Brief Summary
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To evaluate the Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (Part B).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
Advanced Cancer Patients with SARS-CoV-2 positive test \& Covid19 symptoms
Hydroxychloroquine
Hydroxychloroquine 200 mg 3 times a day for 10 days
Azithromycin
Azithromycin 500 mg on day 1 followed by 250 mg/day for 4 days
Cohort 2
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 interventions assigned to this group
Cohort 3
Advanced Cancer Patients with SARS-CoV-2 positive or negative test \& no Covid19 symptoms
No interventions assigned to this group
Cohort 4
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
Hydroxychloroquine
Hydroxychloroquine 200 mg 3 times a day for 10 days
Interventions
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Hydroxychloroquine
Hydroxychloroquine 200 mg 3 times a day for 10 days
Azithromycin
Azithromycin 500 mg on day 1 followed by 250 mg/day for 4 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Locations
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Gustave Roussy
Villejuif, Val De Marne, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020/3078
Identifier Type: OTHER
Identifier Source: secondary_id
2020-001250-21
Identifier Type: -
Identifier Source: org_study_id
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