Patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit
Conditions
Interventions
Product Name: GNS561
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not available
CAS Number: 1914148-72-3
Current Sponsor code: GNS561
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Centre Léon Bérard
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I1. Age 18 or older at the time of enrolment. I2. Histologically or cytologically confirmed diagnosis of advanced or metastatic hematological or solid tumor (hematological or solid tumor, any type and any localization). I3. Documented diagnosis of COVID-19 (diagnostic test performed in a certified laboratory) or symptoms of COVID-19 associated with radiological signs of pneumonia as described by Shi et al.; I4. Cohort 2: patients with pneumonia confirmed by chest imaging, and an oxygen saturation (Sao2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) (Pao2:Fio2) at or below 300 mg Hg. ...See the protocol 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 147 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 126
Exclusion criteria
Exclusion criteria: E1. For cohort 1 only : Patient currently receiving therapy with an anti- PD-1, anti- PD-L1, or anti-CTLA4. E2. For cohort 2 only: Patient currently receiving therapy with an anti- IL-6 or anti-IL-6R. E3. Contraindication to treatment with nivolumab (cohort 1 only) or to tocilizumab (cohort 2 only) as per respective SPC, including known hypersensitivity to one of these study drugs or severe hypersensitivity reaction to any monoclonal antibody. E4. Patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (e.g., quinine, chloroquine, mefloquine). ...See the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to compare versus standard of care short-term mortality rates in advanced or metastatic cancer patients who are positive for COVID-19 treated with a chloroquine analog (GNS561), an anti-PD1 (nivolumab) or an anti-IL-6R antibody (tocilizumab).;Secondary Objective: The secondary objectives will be to describe in each arm of the study: • Time to clinical improvement • Clinical status at days 7, 14 and 28 • Mean change in clinical status from baseline to days 7, 14 and 28 • Overall survival • Length of stay in Intensive Care Unit and in Resuscitation Unit • Duration of mechanical ventilation or high flow oxygen devices • Duration of hospitalization • Rate of throat swab negativation at days 7, 14 and 28 • Quantitative SARS-CoV-2 virus in throat swab at days 7, 14 and 28 • Quantitative SARS-CoV-2 virus in blood at days 7, 14 and 28 • Rate of secondary infection by other documented pathogens (bacteria, fungi) • Biological parameters (hematological parameters and markers of inflammation) • Safety of experimental treatments. And to perform Cost-Effectiveness Analyses (CEA) with Incremental Cost-Effectiveness Ratios (ICERs) expressed in cost per Life Year Gained. ;Primary end point(s): The primary endpoint will be the 28-day survival rate, defined by the proportion of patients still alive 28 days after randomization. ;Timepoint(s) of evaluation of this end point: 28-day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to clinical improvement • Clinical status at D7, D14 and D28 • Mean change in clinical status from baseline to days 7, 14 and 28 • Overall survival ...See the protocol;Timepoint(s) of evaluation of this end point: Assessment at a beginning and throughout the study | — |
Countries
France
Contacts
Public ContactJulien GAUTIER
Centre Léon Bérard
Outcome results
None listed