Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease in French Cancer Patients (ONCOVID)
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|ClinicalTrials.gov Identifier: NCT04341207|
Recruitment Status : Unknown
Verified April 2020 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was: Recruiting
First Posted : April 10, 2020
Last Update Posted : April 10, 2020
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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).
|Condition or disease||Intervention/treatment||Phase|
|Cancer & COVID 19||Drug: Hydroxychloroquine Drug: Azithromycin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||COVID 19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease Upon Hydroxychloroquine and Azithromycin Therapy in French Cancer Patients|
|Actual Study Start Date :||April 3, 2020|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2022|
Experimental: Cohort 1
Advanced Cancer Patients with SARS-CoV-2 positive test & Covid19 symptoms
Hydroxychloroquine 200 mg 3 times a day for 10 days
Azithromycin 500 mg on day 1 followed by 250 mg/day for 4 days
No Intervention: 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 Intervention: Cohort 3
Advanced Cancer Patients with SARS-CoV-2 positive or negative test & no Covid19 symptoms
Experimental: 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 200 mg 3 times a day for 10 days
- Prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients [ Time Frame: Up to 3 months ]
- Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin [ Time Frame: Up to 12 months ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341207
|Contact: Lisa DEROSA, MD||0142114211 ext +firstname.lastname@example.org|
|Contact: Stefan MICHIELS, MD||0142114211 ext +33||Stefan.email@example.com|
|Villejuif, Val De Marne, France, 94800|
|Contact: Lisa DEROSA, MD 0142114211 ext +33 firstname.lastname@example.org|
|Contact: Stefan MICHIELS, MD 0142114211 ext +33 email@example.com|
|Responsible Party:||Gustave Roussy, Cancer Campus, Grand Paris|
|Other Study ID Numbers:||
2020/3078 ( Other Identifier: CSET number )
|First Posted:||April 10, 2020 Key Record Dates|
|Last Update Posted:||April 10, 2020|
|Last Verified:||April 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action