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

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ClinicalTrials.gov Identifier: NCT04341207
Recruitment Status : Unknown
Verified April 2020 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
First Posted : April 10, 2020
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Tracking Information
First Submitted Date  ICMJE April 8, 2020
First Posted Date  ICMJE April 10, 2020
Last Update Posted Date April 10, 2020
Actual Study Start Date  ICMJE April 3, 2020
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • Prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients [ Time Frame: Up to 3 months ]
  • Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin [ Time Frame: Up to 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease in French Cancer Patients
Official Title  ICMJE COVID 19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease Upon Hydroxychloroquine and Azithromycin Therapy in French Cancer Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer & COVID 19
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cohort 1
    Advanced Cancer Patients with SARS-CoV-2 positive test & Covid19 symptoms
    Interventions:
    • Drug: Hydroxychloroquine
    • Drug: Azithromycin
  • 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
    Intervention: Drug: Hydroxychloroquine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 9, 2020)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04341207
Other Study ID Numbers  ICMJE 2020-001250-21
2020/3078 ( Other Identifier: CSET number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Gustave Roussy, Cancer Campus, Grand Paris
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Gustave Roussy, Cancer Campus, Grand Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gustave Roussy, Cancer Campus, Grand Paris
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP