<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/NCT04422470</url>
  </required_header>
  <id_info>
    <org_study_id>CHRONOS19</org_study_id>
    <nct_id>NCT04422470</nct_id>
  </id_info>
  <brief_title>Registry of Patients With Hematologic Disease and COVID-19 in Russia</brief_title>
  <acronym>CHRONOS19</acronym>
  <official_title>Observational Prospective Cohort Study - Registry of Patients With Hematologic Disease and COVID-19 in Russia (CHRONOS19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Research Center for Hematology, Russia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Foundation for Cancer Research Support (RakFond)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Enrollme.ru, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Research Center for Hematology, Russia</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>
      This is an observational prospective cohort study to evaluate the clinical course and&#xD;
      outcomes of COVID-19 and the underlying disease in patients with hematologic disease&#xD;
      (malignant or non-malignant).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a web-based registry. After registration, physicians from hematology clinical centers&#xD;
      and hospitals in Russia will receive access to the web platform for clinical trial management&#xD;
      to fill in the online data collection form in a de-identified manner. This form includes&#xD;
      questions about general clinical history of hematologic disease, manifestation, treatment,&#xD;
      and the course of COVID-19, concomitant conditions, consequences on the hematologic disease,&#xD;
      short-term and long-term outcomes. It will take approximately 10 min to answer the questions.&#xD;
      Patients will be followed for 30 days after COVID-19 diagnosis and up to 6 months for&#xD;
      hematologic disease outcomes and overall survival assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Actual">January 18, 2022</completion_date>
  <primary_completion_date type="Actual">August 22, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>30-day all-cause mortality</measure>
    <time_frame>30 day</time_frame>
    <description>Rate of death from any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>COVID-19 complications</measure>
    <time_frame>30 day</time_frame>
    <description>Rate of COVID-19 complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU admission</measure>
    <time_frame>30 day</time_frame>
    <description>Rate of ICU admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilation / O2 requirement</measure>
    <time_frame>30 day</time_frame>
    <description>Rate of mechanical ventilation / O2 requirement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse or progression of hematologic disease</measure>
    <time_frame>30 day, 90 day and 180 day</time_frame>
    <description>Rate of relapse or progression of hematologic disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>30 day, 90 day and 180 day</time_frame>
    <description>Number of patients alive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk factors</measure>
    <time_frame>30 day, 90 day and 180 day</time_frame>
    <description>Putative risk factors for the severity and lethality of COVID-19</description>
  </secondary_outcome>
  <enrollment type="Actual">666</enrollment>
  <condition>Coronavirus Infection and Hematologic Diseases</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-interventional study</intervention_name>
    <description>Non-interventional study</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with hematologic disease (both malignant and non-malignant) infected with&#xD;
        SARS-CoV-2&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Any previously or currently diagnosed hematologic disease&#xD;
&#xD;
          -  Laboratory confirmed or suspected (based on clinical symptoms and/or CT) COVID-19&#xD;
&#xD;
          -  Known outcome of COVID-19 in case of retrospective data input (protocol allows&#xD;
             retrospective data input for patients who were prospectively followed in local&#xD;
             centers)&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        • Loss of follow-up within 30 days after COVID-19 diagnosis&#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>Elena Parovichnikova</last_name>
    <role>Study Chair</role>
    <affiliation>National Research Center for Hematology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regional Clinical Hospital No1</name>
      <address>
        <city>Ekaterinburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican Clinical Hospital of Tatarstan</name>
      <address>
        <city>Kazan</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Hospital n.a. V.V. Veresaev</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital n.a. S.P. Botkin</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>N.V. Sklifosovsky Emergency Institute</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Research Center for Hematology</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Hospital N.A. Semashko</name>
      <address>
        <city>Nizhny Novgorod</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Hospital</name>
      <address>
        <city>Novosibirsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Hospital</name>
      <address>
        <city>Omsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican Clinical Hospital No4</name>
      <address>
        <city>Saransk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republic Clinical Hospital n.a. N.A. Semashko</name>
      <address>
        <city>Ulan-Ude</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Hospital</name>
      <address>
        <city>Vladimir</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Hospital No2</name>
      <address>
        <city>Vladivostok</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Hospital</name>
      <address>
        <city>Yaroslavl</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Blood diseases</keyword>
  <keyword>Leukemia</keyword>
  <keyword>Lymphoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Hematologic Diseases</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/NCT04422470
org study id: CHRONOS19
nct id: NCT04422470
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an observational prospective cohort study to evaluate the clinical course and
      outcomes of COVID-19 and the underlying disease in patients with hematologic disease
      (malignant or non-malignant).
This is a web-based registry. After registration, physicians from hematology clinical centers
      and hospitals in Russia will receive access to the web platform for clinical trial management
      to fill in the online data collection form in a de-identified manner. This form includes
      questions about general clinical history of hematologic disease, manifestation, treatment,
      and the course of COVID-19, concomitant conditions, consequences on the hematologic disease,
      short-term and long-term outcomes. It will take approximately 10 min to answer the questions.
      Patients will be followed for 30 days after COVID-19 diagnosis and up to 6 months for
      hematologic disease outcomes and overall survival assessment.
observational model: Cohort
time perspective: Prospective
measure: 30-day all-cause mortality
time frame: 30 day
description: Rate of death from any cause
measure: COVID-19 complications
time frame: 30 day
description: Rate of COVID-19 complications
measure: ICU admission
time frame: 30 day
description: Rate of ICU admission
measure: Mechanical ventilation / O2 requirement
time frame: 30 day
description: Rate of mechanical ventilation / O2 requirement
measure: Relapse or progression of hematologic disease
time frame: 30 day, 90 day and 180 day
description: Rate of relapse or progression of hematologic disease
measure: Overall survival
time frame: 30 day, 90 day and 180 day
description: Number of patients alive
measure: Risk factors
time frame: 30 day, 90 day and 180 day
description: Putative risk factors for the severity and lethality of COVID-19
intervention type: Other
intervention name: Non-interventional study
description: Non-interventional study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elena Parovichnikova
role: Study Chair
affiliation: National Research Center for Hematology
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Hematologic Diseases
sharing ipd: No