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A prospective, controlled, randomized, multicenter study of the efficacy of an autophagy inhibitor (GNS561), an anti-NKG2A (monalizumab) and an anti-C5aR (avdoralimab) compared to the standard of care in patients with advanced or metastatic cancer and SAR

France, 2020 - 2021
Reference ID
FRESH-PEF73840-en
Producer(s)
Virginie Avrillon
Metadata
DDI/XML JSON
Created on
Nov 15, 2025
Last modified
Nov 15, 2025
Page views
4
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Data Access
  • Metadata production

    • Identification

    Survey ID number

    FRESH-PEF73840-en
    Title

    A prospective, controlled, randomized, multicenter study of the efficacy of an autophagy inhibitor (GNS561), an anti-NKG2A (monalizumab) and an anti-C5aR (avdoralimab) compared to the standard of care in patients with advanced or metastatic cancer and SARS-CoV-2 (COVID-19) infection.
    Abbreviation or Acronym

    ImmunONCOVID-20
    Country
    Name
    France
    Abstract

    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 an autophagy inhibitor (GNS561), an anti-NKG2A (monalizumab) or an anti-C5aR (avdoralimab). The primary endpoint will be the 28-day survival rate, defined by the proportion of patients still alive 28 days after randomization. The 28-day survival rate will be described in each arm of each cohort.
    Kind of Data

    ['Clinical data','Biological data','Economic data']
    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary URI
    Oncology health theme
    cim-11 http://id.who.int/icd/entity/1400642551
    cim-11 http://id.who.int/icd/entity/975345242
    Healthcare system determinants: Use of care health determinant
    Healthcare system determinants health determinant

    Coverage

    Universe

    {
    "level_sex_clusion_I": [
    "Male",
    "Female"
    ],
    "level_age_clusion_I": [
    "Young Adult (19 to 24 years)",
    "Adult (25 to 44 years)",
    "Middle Aged (45 to 64 years)",
    "Aged (65 to 79 years)",
    "Aged, 80 and over (80 years and more)"
    ],
    "level_type_clusion_I": [
    "Patients population"
    ],
    "level_type_clusion_other": "",
    "clusion_I": "",
    "clusion_E": ""
    }

    Producers and sponsors

    Primary investigators
    Name
    Virginie Avrillon
    Funding Agency/Sponsor
    Name
    BPIFRANCE

    Study authorization

    Agency
    Agency name
    Autre

    Sampling

    Sample frame

    Unit Type

    ['Through organizations (health services or institutions, schools, businesses, etc.)']
    Sampling Procedure

    ['Probability: Stratified']

    Survey instrument

    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2020 2021
    Mode of data collection
    • Converting or copying information into a structured record

    Study activities

    Study activities
    Type
    primary evaluation
    Description
    Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception

    Quality standards

    Other quality statement

    Remote and on-site monitoring

    Data Access

    Availability Status

    To be defined

    Metadata production

    DDI Document ID

    FRESH-PEF73840-en
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