<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04452604</url>
  </required_header>
  <id_info>
    <org_study_id>COVLA</org_study_id>
    <nct_id>NCT04452604</nct_id>
  </id_info>
  <brief_title>Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19</brief_title>
  <acronym>COVLA</acronym>
  <official_title>National Retrospective Monitoring of Patients With Acute Leukemia Infected by COronaVirus Disease 2019 (COVID-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>French Innovative Leukemia Organisation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Acute Leukemia French Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Group for Research in Adult Acute Lymphoblastic Leukemia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>French Innovative Leukemia Organisation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The COVID-19 epidemic (Coronavirus Disease 2019) currently raging in France is an emerging&#xD;
      infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2).&#xD;
      Epidemiologically, acute myeloblastic leukemias (AML) are the most common of acute leukemias.&#xD;
      The incidence of acute lymphoblastic leukemia (ALL) is 900 new cases in France in 2018, of&#xD;
      which 57% in humans. The treatments administered to AML and ALL patients induce variable&#xD;
      immunosuppression: neutropenia, neuropathy, deficits in humoral or cellular immunity or&#xD;
      combinations of these deficits. Patients with AML or ALL therefore represent a population at&#xD;
      high risk of developing a serious form in the event of infection with SARS-CoV-2. To date, no&#xD;
      data is available in the literature to assess the impact of the COVID-19 epidemic in the&#xD;
      population of patients with acute leukemia.&#xD;
&#xD;
      The main objective of the study is to determine the clinical and biological prognostic&#xD;
      factors during SARS-CoV-2 infection in patients with acute leukemia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2020</start_date>
  <completion_date type="Actual">July 7, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical prognostic factors for infection with COVID-19</measure>
    <time_frame>Day 0</time_frame>
    <description>Factors associated with overall survival will be analyzed : center, sex, leukemia subtype, previous treatment by corticosteroids, and comorbidities (respiratory, renal, cardiac, weight, diabetes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biological prognostic factors for infection with COVID-19</measure>
    <time_frame>Day 0</time_frame>
    <description>neutrophils and lymphocytes count at the time of SARS-COV2 infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical care of Coronavirus infection</measure>
    <time_frame>within 12 months after diagnosis</time_frame>
    <description>Describe the management carried out concerning coronavirus infection and its impact of the treatment of acute leukemia (non-invasive ventilation, orotracheal intubation, vasopressor requiring, treatments used, cause of death</description>
  </primary_outcome>
  <enrollment type="Actual">79</enrollment>
  <condition>Acute Myeloblastic Leukemia</condition>
  <condition>Acute Lymphoblastic Leukemia</condition>
  <condition>SARS-CoV-2</condition>
  <eligibility>
    <study_pop>
      <textblock>
        COVID-19 infected patients with AML or ALL&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of acute leukemia according to WHO criteria 2016 ≤ 5 years&#xD;
&#xD;
          -  Diagnosis of a proven or probable SARS-CoV-2 infection according to the following&#xD;
             criteria:&#xD;
&#xD;
               1. Proven infection: positive Polymerase Chain Reaction (PCR) regardless of the&#xD;
                  radio-clinical picture (other tests made available later and having good&#xD;
                  diagnostic performance will be accepted)&#xD;
&#xD;
               2. Probable infection: negative PCR but association of&#xD;
&#xD;
                    1. Evocative clinical signs, of recent installation: fever, respiratory signs&#xD;
                       (cough, dyspnea, chest pain), body aches, sore throat, rhinorrhea, headache,&#xD;
                       diarrhea / abdominal pain, frank asthenia, loss of taste / smell,&#xD;
                       conjunctivitis, type of frostbite AND&#xD;
&#xD;
                    2. evocative radiological signs, on CT: diffuse or diffuse aspect of frosted&#xD;
                       glass, condensations including pseudo-nodular condensations, association of&#xD;
                       frosted glass and condensation within the same lesion, nodules and&#xD;
                       micronodules, thickening of the interlobular septa) or on chest radiography:&#xD;
                       interstitial, alveolo-interstitial or alveolar syndrome, single or bilateral&#xD;
                       AND&#xD;
&#xD;
                    3. absence of differential diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre-Yves DUMAS, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>French Innovative Leukemia Organisation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU ANGERS - Maladies du sang</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Avignon</name>
      <address>
        <city>Avignon</city>
        <zip>84000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de la Côte Basque - Hématologie</name>
      <address>
        <city>Bayonne</city>
        <zip>64109</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Caen - IHBN - Hématologie Clinique</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Sud Francilien</name>
      <address>
        <city>Corbeil-essonnes</city>
        <zip>91100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Dunkerque</name>
      <address>
        <city>Dunkerque</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble - Hopital Michallon</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier du Mans</name>
      <address>
        <city>Le Mans</city>
        <zip>72000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Vicent de Paul</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Limoges</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli-Calmettes - Hématologie 2</name>
      <address>
        <city>Marseille</city>
        <zip>13000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOPITAL SAINT ELOI - Hematologie</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOPITAL E. MULLER - Hématologie</name>
      <address>
        <city>Mulhouse</city>
        <zip>68070</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU HOTEL DIEU - Hématologie Clinique</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Caremeau</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique</name>
      <address>
        <city>Perpignan</city>
        <zip>66000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bordeaux Pessac</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Reims - Hôpital Robert Debré - Hématologie Clinique</name>
      <address>
        <city>Reims</city>
        <zip>51100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Pontchaillou - Hématologie</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu de La Reunion - Site Sud</name>
      <address>
        <city>Saint-pierre</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie Lucien Neuwirth</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <zip>42271</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Brabois</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Versailles</name>
      <address>
        <city>Versailles</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>July 26, 2022</last_update_submitted>
  <last_update_submitted_qc>July 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04452604
org study id: COVLA
nct id: NCT04452604
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The COVID-19 epidemic (Coronavirus Disease 2019) currently raging in France is an emerging
      infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2).
      Epidemiologically, acute myeloblastic leukemias (AML) are the most common of acute leukemias.
      The incidence of acute lymphoblastic leukemia (ALL) is 900 new cases in France in 2018, of
      which 57% in humans. The treatments administered to AML and ALL patients induce variable
      immunosuppression: neutropenia, neuropathy, deficits in humoral or cellular immunity or
      combinations of these deficits. Patients with AML or ALL therefore represent a population at
      high risk of developing a serious form in the event of infection with SARS-CoV-2. To date, no
      data is available in the literature to assess the impact of the COVID-19 epidemic in the
      population of patients with acute leukemia.

      The main objective of the study is to determine the clinical and biological prognostic
      factors during SARS-CoV-2 infection in patients with acute leukemia.
observational model: Cohort
time perspective: Retrospective
measure: Clinical prognostic factors for infection with COVID-19
time frame: Day 0
description: Factors associated with overall survival will be analyzed : center, sex, leukemia subtype, previous treatment by corticosteroids, and comorbidities (respiratory, renal, cardiac, weight, diabetes)
measure: Biological prognostic factors for infection with COVID-19
time frame: Day 0
description: neutrophils and lymphocytes count at the time of SARS-COV2 infection
measure: Medical care of Coronavirus infection
time frame: within 12 months after diagnosis
description: Describe the management carried out concerning coronavirus infection and its impact of the treatment of acute leukemia (non-invasive ventilation, orotracheal intubation, vasopressor requiring, treatments used, cause of death
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre-Yves DUMAS, Dr
role: Principal Investigator
affiliation: French Innovative Leukemia Organisation
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country: France
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Myeloid, Acute
sharing ipd: No