Clinical trial · Interventional
Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease in French Cancer Patients
COVID 19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease Upon Hydroxychloroquine and Azithromycin Therapy in French Cancer Patients
NCT04341207CI-TRIAL-00044594ONCOVIDunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer & COVID 19 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azithromycin | Drug | — | UNRESOLVED |
| Hydroxychloroquine | Drug | Hydroxychloroquine | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Advanced Cancer Patients with SARS-CoV-2 positive test \& Covid19 symptoms
- interventionNames
- Drug: Hydroxychloroquine
- Drug: Azithromycin
- type
- NO_INTERVENTION
- label
- Cohort 2
- description
- 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.
- type
- NO_INTERVENTION
- label
- Cohort 3
- description
- Advanced Cancer Patients with SARS-CoV-2 positive or negative test \& no Covid19 symptoms
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.