NCT04341207

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 10, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

April 8, 2020

Last Update Submit

April 9, 2020

Conditions

Cancer & COVID 19

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

Cohort 1

EXPERIMENTAL

Advanced Cancer Patients with SARS-CoV-2 positive test \& Covid19 symptoms

Drug: HydroxychloroquineDrug: Azithromycin

Cohort 2

NO INTERVENTION

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.

Cohort 3

NO INTERVENTION

Advanced Cancer Patients with SARS-CoV-2 positive or negative test \& no Covid19 symptoms

Cohort 4

EXPERIMENTAL

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

Interventions

HydroxychloroquineDRUG

Hydroxychloroquine 200 mg 3 times a day for 10 days

Cohort 1Cohort 4
AzithromycinDRUG

Azithromycin 500 mg on day 1 followed by 250 mg/day for 4 days

Cohort 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy

Villejuif, Val De Marne, 94800, France

RECRUITING

MeSH Terms

Conditions

NeoplasmsCOVID-19

Interventions

HydroxychloroquineAzithromycin

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Central Study Contacts

Lisa DEROSA, MD

CONTACT

0142114211lisa.derosa@gustaveroussy.fr

Stefan MICHIELS, MD

CONTACT

0142114211Stefan.michiels@gustaveroussy.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2020

First Posted

April 10, 2020

Study Start

April 3, 2020

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

April 10, 2020

Record last verified: 2020-04

Locations

FR(1)