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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341207
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Cancer & COVID 19 Drug: Hydroxychloroquine Drug: Azithromycin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COVID 19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease Upon Hydroxychloroquine and Azithromycin Therapy in French Cancer Patients
Actual Study Start Date : April 3, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022


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




Primary Outcome Measures :
  1. Prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients [ Time Frame: Up to 3 months ]
  2. Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin [ Time Frame: Up to 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341207


Contacts
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Contact: Lisa DEROSA, MD 0142114211 ext +33 lisa.derosa@gustaveroussy.fr
Contact: Stefan MICHIELS, MD 0142114211 ext +33 Stefan.michiels@gustaveroussy.fr

Locations
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France
Gustave Roussy Recruiting
Villejuif, Val De Marne, France, 94800
Contact: Lisa DEROSA, MD    0142114211 ext +33    lisa.derosa@gustaveroussy.fr   
Contact: Stefan MICHIELS, MD    0142114211 ext +33    stefan.michiels@gustaveroussy.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT04341207    
Other Study ID Numbers: 2020-001250-21
2020/3078 ( Other Identifier: CSET number )
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents