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

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

Tracking Information

• First Submitted Date: April 8, 2020
• First Posted Date: April 10, 2020
• Last Update Posted Date: April 10, 2020
• Actual Study Start Date: April 3, 2020
• Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease in French Cancer Patients
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cancer & COVID 19

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 9, 2020): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2022
• Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04341207
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Current Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
• Original Responsible Party: Same as current
• Current Study Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Gustave Roussy, Cancer Campus, Grand Paris
• Verification Date: April 2020