Cancer & COVID 19 Clinical Trial
— ONCOVIDOfficial title:
COVID 19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease Upon Hydroxychloroquine and Azithromycin Therapy in French Cancer Patients
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).
| Status | Recruiting |
| Enrollment | 1000 |
| Est. completion date | April 2022 |
| Est. primary completion date | April 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Gustave Roussy | Villejuif | Val De Marne |
| Lead Sponsor | Collaborator |
|---|---|
| Gustave Roussy, Cancer Campus, Grand Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients | Up to 3 months | ||
| Primary | Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin | Up to 12 months |