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

Gustave Roussy

Status and phase: Unknown; Phase 2

Conditions: Cancer & COVID 19

Treatments: Drug: Azithromycin; Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04341207

2020/3078 (Other Identifier)

2020-001250-21

Details and patient eligibility

About

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).

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 4 patient groups

Cohort 1

Experimental group

Description:

Advanced Cancer Patients with SARS-CoV-2 positive test \& Covid19 symptoms

Treatment:

Drug: Azithromycin

Drug: Hydroxychloroquine

Cohort 2

No Intervention group

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.

Cohort 3

No Intervention group

Description:

Advanced Cancer Patients with SARS-CoV-2 positive or negative test \& no Covid19 symptoms

Cohort 4

Experimental group

Description:

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

Treatment:

Drug: Hydroxychloroquine