<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/NCT04416438</url>
  </required_header>
  <id_info>
    <org_study_id>COVIM</org_study_id>
    <nct_id>NCT04416438</nct_id>
  </id_info>
  <brief_title>COVID-19 Epidemic and Patients With Myeloproliferative Neoplasias</brief_title>
  <acronym>COVIM</acronym>
  <official_title>Observational Study of the Impact of the COronaVirus Disease 2019 (COVID-19) Epidemic on Patients With Myeloproliferative Neoplasias</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>French Innovative Leukemia Organisation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>French Intergroup of Myeloproliferative syndromes</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 classic myeloproliferative neoplasias (MNP), including polycythemia vera (PV), essential&#xD;
      thrombocythemia (ET), primary myelofibrosis (PMF) or secondary to PV or ET, are among the&#xD;
      most frequent of malignant hemopathies, with overall prevalence estimated at around 10,000&#xD;
      patients followed in France. Due to the median age of patients around 65, the frequency of&#xD;
      cardiovascular complications of these thrombogenic diseases and the impact of cytoreductive&#xD;
      treatments on immune cells, these patients are considered to be at risk of developing forms&#xD;
      severe of COVID-19. This study will assess the impact of MNPs on the risk of developing a&#xD;
      severe form of COVID-19, identify new risk factors linked to the disease as well as the&#xD;
      impact of treatments for MNPs according to their pharmacological class.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is a descriptive, prospective epidemiological study using retrospective patient data,&#xD;
      multicenter, non-interventional, carried out in FIM (French Intergroup of Myeloproliferative&#xD;
      syndromes) / FILO (French Innovative Leukemia Organization) centers.&#xD;
&#xD;
      This is an exploratory descriptive study in order to put in place as soon as possible a&#xD;
      possible strategy for the protection of patients most at risk.&#xD;
&#xD;
      The study will include all consecutive patients with MNP according to the WHO (World Health&#xD;
      Organization) classification seen in consultation or teleconsultation over the duration of&#xD;
      the study, whether or not they have had a COVID-19 infection.&#xD;
&#xD;
      The collection of clinical data, treatment regimens and survival and death data will be&#xD;
      carried out by the investigator or a member of his medical team, after delivering an&#xD;
      information note to the patient informing him of the computerized processing of his data,&#xD;
      subject to the patient's non-objection.&#xD;
&#xD;
      The diagnosis of asymptomatic COVID 19 will be made on the presence of a positive serology&#xD;
      and on the absence of clinical signs on questioning.&#xD;
&#xD;
      The presence of a symptomatic COVID 19 infection will be posed on the presence of clinical&#xD;
      signs +/- CT as identified by the practitioner who treated the patient and confirmed or not&#xD;
      by a positive PCR and / or a positive serology.&#xD;
&#xD;
      Data collected:&#xD;
&#xD;
        -  Socio-demographic data (gender, date of birth)&#xD;
&#xD;
        -  Description of hemopathy and its treatment&#xD;
&#xD;
        -  Description of COVID-19 infection and its management&#xD;
&#xD;
        -  Biological data: blood count, specific COVID-19 test results if available (PCR,&#xD;
           serology).&#xD;
&#xD;
        -  History, comorbidities&#xD;
&#xD;
        -  Evolution of COVID-19 infection and possible specific treatment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 18, 2020</start_date>
  <completion_date type="Actual">September 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Rate of serious coronavirus infection in different MNP patient subgroups</measure>
    <time_frame>Through inclusion period, an average of 6 months</time_frame>
    <description>The crude rate of cumulative incidence of serious infection proven to COVID-19, compared to the population of the same age, same sex, same region of residence during the epidemic period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of MNP patients who had COVID-19 infection during the 2020 epidemic.</measure>
    <time_frame>Through inclusion period, an average of 6 months</time_frame>
    <description>Number of MNP patients who had COVID-19 compared to general population in France</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of death of MNP patients who had COVID-19</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Number of MNP patients who died from COVID-19</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of passages in intensive care with need for mechanical ventilation</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Number of MNP patients hospitalized in intensive care with need for mechanical ventilation</description>
  </primary_outcome>
  <enrollment type="Actual">1793</enrollment>
  <condition>Myeloproliferative Neoplasm</condition>
  <condition>COVID-19 Infection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Classic myeloproliferative neoplasias (MPN), including polycythemia vera&#xD;
        (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF) or secondary to PV or ET,&#xD;
        and infected by COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with PV, ET, PMF or MF secondary to PV or ET diagnosed before the COVID-19&#xD;
             pandemic&#xD;
&#xD;
          -  Seen in consultation or teleconsultation from May 2020 or deceased if the investigator&#xD;
             became aware of this death during the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate in the study&#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>Jean-Jacques KILADJIAN, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>FIM</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laurence LEGROS, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>FIM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Paris Saint Louis</name>
      <address>
        <city>Paris</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>October 17, 2022</last_update_submitted>
  <last_update_submitted_qc>October 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 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>COVID-19</mesh_term>
    <mesh_term>Myeloproliferative Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT04416438
org study id: COVIM
nct id: NCT04416438
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The classic myeloproliferative neoplasias (MNP), including polycythemia vera (PV), essential
      thrombocythemia (ET), primary myelofibrosis (PMF) or secondary to PV or ET, are among the
      most frequent of malignant hemopathies, with overall prevalence estimated at around 10,000
      patients followed in France. Due to the median age of patients around 65, the frequency of
      cardiovascular complications of these thrombogenic diseases and the impact of cytoreductive
      treatments on immune cells, these patients are considered to be at risk of developing forms
      severe of COVID-19. This study will assess the impact of MNPs on the risk of developing a
      severe form of COVID-19, identify new risk factors linked to the disease as well as the
      impact of treatments for MNPs according to their pharmacological class.
It is a descriptive, prospective epidemiological study using retrospective patient data,
      multicenter, non-interventional, carried out in FIM (French Intergroup of Myeloproliferative
      syndromes) / FILO (French Innovative Leukemia Organization) centers.

      This is an exploratory descriptive study in order to put in place as soon as possible a
      possible strategy for the protection of patients most at risk.

      The study will include all consecutive patients with MNP according to the WHO (World Health
      Organization) classification seen in consultation or teleconsultation over the duration of
      the study, whether or not they have had a COVID-19 infection.

      The collection of clinical data, treatment regimens and survival and death data will be
      carried out by the investigator or a member of his medical team, after delivering an
      information note to the patient informing him of the computerized processing of his data,
      subject to the patient's non-objection.

      The diagnosis of asymptomatic COVID 19 will be made on the presence of a positive serology
      and on the absence of clinical signs on questioning.

      The presence of a symptomatic COVID 19 infection will be posed on the presence of clinical
      signs +/- CT as identified by the practitioner who treated the patient and confirmed or not
      by a positive PCR and / or a positive serology.

      Data collected:

        -  Socio-demographic data (gender, date of birth)

        -  Description of hemopathy and its treatment

        -  Description of COVID-19 infection and its management

        -  Biological data: blood count, specific COVID-19 test results if available (PCR,
           serology).

        -  History, comorbidities

        -  Evolution of COVID-19 infection and possible specific treatment
observational model: Cohort
time perspective: Retrospective
measure: Rate of serious coronavirus infection in different MNP patient subgroups
time frame: Through inclusion period, an average of 6 months
description: The crude rate of cumulative incidence of serious infection proven to COVID-19, compared to the population of the same age, same sex, same region of residence during the epidemic period.
measure: Proportion of MNP patients who had COVID-19 infection during the 2020 epidemic.
time frame: Through inclusion period, an average of 6 months
description: Number of MNP patients who had COVID-19 compared to general population in France
measure: Rate of death of MNP patients who had COVID-19
time frame: Through study completion, an average of 1 year
description: Number of MNP patients who died from COVID-19
measure: Rate of passages in intensive care with need for mechanical ventilation
time frame: Through study completion, an average of 1 year
description: Number of MNP patients hospitalized in intensive care with need for mechanical ventilation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Jacques KILADJIAN, Pr
role: Principal Investigator
affiliation: FIM
last name: Laurence LEGROS, Dr
role: Principal Investigator
affiliation: FIM
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Myeloproliferative Disorders