Patients eligible for, or under, or recently treated by chemotherapy (CT) and/or immune-checkpoint blockade (ICB) for the treatment of solid tumors or hematological malignancies.
Conditions
Interventions
Trade Name: Plaquenil 200mg
Product Name: hydroxychloroquine
Pharmaceutical Form: Coated tablet
Trade Name: Azithromycine
Pharmaceutical Form: Coated tablet
Sponsors
GUSTAVE ROUSSY
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: • Patients with known allergy to hydroxychloroquine or chloroquine, • Patients with known allergy to azithromycine, erythromycine, or all antibiotics belonging to the macrolide family. • Patients currently treated with Tamoxifen • Patients with known contra-indication to treatment with the study drug, including retinopathy, G6PD deficiency, QT prolongation and severe hepato-cellular insufficiency. • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients (Part A). To evaluate the Covid-19 disease mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (Part B). ;Secondary Objective: To evaluate the safety, Covid-19 disease severity, response to cancer treatment, Progression-free survival (PFS), cancer mortality, and Overall Survival (OS) of cancer patients infected by SARS-Cov2. To follow the evolution of SARS-CoV-2 infection and viral load in different compartments (nasal epithelia, blood and urine) during the course of therapy. To evaluate the impact of mutation shifts in SARS-CoV-2 genotype (in sever cases only). To follow the humoral and cellular immune responses to the virus, to cancer and control antigens during infection with SARS-CoV-2. To deconvolute SARS-CoV-2-specific MHC class I and II binding epitopes to follow T cell responses with tetramers and Elispot assays, as well as cancer antigens (NY-ESO-1, MAGEn, preprocalcitonin, actinin...)-specific responses. ;Primary end point(s): The primary endpoints of the study are for the: o Part A: prevalence at first visit and 12 weeks cumulative incidence (in a competing risk model with mortality) of SARS-CoV-2 positive subjects (RT-PCR) o Part B: Covid-19 disease specific mortality;Timepoint(s) of evaluation of this end point: 12 weeks and 12 month (mortality) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety will be measured by the incidence of all treatment-related adverse events (CTCAE v.5 of any grade), serious adverse events (any cause), deaths (any cause). Covid-19 disease severity (ordinal score). Objective response to Cancer Treatment (as per routine procedure). Progression-free survival (PFS). Short term cancer specific mortality. Overall Survival (OS). ;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
France
Outcome results
None listed