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

Phase 2

• Conditions: Cancer & COVID 19
• Interventions: Drug: Hydroxychloroquine; Drug: Azithromycin

• Registration Number: NCT04341207
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-03
• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-09
• Last Update Submitted: 2020-04-09
• Study First Posted: 2020-04-10
• Last Update Posted: 2020-04-10
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Hydroxychloroquine	Advanced Cancer Patients with SARS-CoV-2 positive test \& Covid19 symptoms
Cohort 1	Azithromycin	Advanced Cancer Patients with SARS-CoV-2 positive test \& Covid19 symptoms
Cohort 4	Hydroxychloroquine	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

Primary Outcome Measures

Name	Time	Method
Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin	Up to 12 months
Prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients	Up to 3 months

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France