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

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).

Study Overview

• Status: Unknown
• Conditions: Cancer & COVID 19
• Intervention / Treatment: Drug: Hydroxychloroquine; Drug: Azithromycin

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lisa DEROSA, MD; Phone Number: +33 0142114211; Email: lisa.derosa@gustaveroussy.fr
• Study Contact Backup: Name: Stefan MICHIELS, MD; Phone Number: +33 0142114211; Email: Stefan.michiels@gustaveroussy.fr

Study Locations

• France
  • Val De Marne
    • Villejuif, Val De Marne, France, 94800
      • Recruiting
      • Gustave Roussy
      • Contact: Lisa DEROSA, MD; Phone Number: +33 0142114211; Email: lisa.derosa@gustaveroussy.fr
      • Contact: Stefan MICHIELS, MD; Phone Number: +33 0142114211; Email: Stefan.michiels@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Advanced Cancer Patients with SARS-CoV-2 positive test & Covid19 symptoms	Drug: Hydroxychloroquine; Hydroxychloroquine 200 mg 3 times a day for 10 days; Drug: Azithromycin; 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	Drug: Hydroxychloroquine; Hydroxychloroquine 200 mg 3 times a day for 10 days

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2020
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Azithromycin; Hydroxychloroquine
• Other Study ID Numbers: 2020-001250-21; 2020/3078 (Other Identifier: CSET number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No