<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/NCT04450017</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-ICU</org_study_id>
    <nct_id>NCT04450017</nct_id>
  </id_info>
  <brief_title>Clinical Features of Severe Patients With COVID-19</brief_title>
  <official_title>Clinical Features of Severe Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal Research Clinical Center of Federal Medical &amp; Biological Agency, Russia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal Research Clinical Center of Federal Medical &amp; Biological Agency, Russia</source>
  <oversight_info>
    <has_dmc>Yes</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>
      As coronavirus disease 2019 (COVID-19) spreads across the world, the intensive care unit&#xD;
      (ICU) community must prepare for the challenges associated with this pandemic. Providing an&#xD;
      efficient care to the patients of the most severely affected category - intensive care unit&#xD;
      (ICU) patients - has become one of the serious problems appearing in the COVID-19 pandemics.&#xD;
      A typical patient's clinical portrait in ICU of COVID centers is very similar in different&#xD;
      countries, however, the key to improve the treatment results for critically ill patients has&#xD;
      not yet been found. Data on predictors of severe course in COVID-19 is limited. Knowledge of&#xD;
      predictors of severe course of disease can lead to different selection of therapeutic&#xD;
      strategy, determine the group of risk of patients for severe course of disease, and improve&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical disease (COVID-19) results in critical illness in about 5% of patients. The aim&#xD;
      of the study is to identify predictors of the severe pneumonia caused by the SARS-CoV-2&#xD;
      virus, and to describe the clinical features of patients admitted to an ICU of the&#xD;
      COVID-center of the Federal Research Clinical Center of Federal Medical &amp; Biological Agency&#xD;
      on the first day and in dynamics till discharge from the ICU or death.&#xD;
&#xD;
      The demographic and clinical data will be collected. Laboratory data (hemoglobin,&#xD;
      lymphocytes, neutrophil to lymphocyte ratio, D-dimer level, IL-6, procalcitonin, glucose&#xD;
      level, high-sensitive troponin Т, vitamin D level, signs of the presence of a secondary&#xD;
      bacterial infection, immunogram and Instrumental data (CT-scan, Electrocardiography,&#xD;
      echocardiography, arterial and venous ultrasound investigation) will be analysed.&#xD;
&#xD;
      This study is singlecentral observational trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 6, 2020</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mechanical ventilation duration</measure>
    <time_frame>30 days</time_frame>
    <description>The amount of mechanical ventilation days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-invasive Mechanical ventilation duration</measure>
    <time_frame>30 days</time_frame>
    <description>The amount of Non-invasive mechanical ventilation days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>60 days</time_frame>
    <description>The dead and survived patients ratio</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Сomplete blood count</measure>
    <time_frame>Change from baseline on day 5 during ICU treatment</time_frame>
    <description>Сomplete blood count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry analysis</measure>
    <time_frame>Change from baseline on day 5 during ICU treatment</time_frame>
    <description>Biochemistry analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Сomplete blood count dynamics</measure>
    <time_frame>Change from baseline on day 15 during ICU treatment</time_frame>
    <description>Сomplete blood count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry analysis dynamics</measure>
    <time_frame>Change from baseline on day 15 during ICU treatment</time_frame>
    <description>Biochemistry analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Computer tomography</measure>
    <time_frame>Change from baseline on day 5 during ICU treatment</time_frame>
    <description>Computer tomography of lungs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High-sensitive troponin Т</measure>
    <time_frame>Change from baseline on day 5 during ICU treatment</time_frame>
    <description>High-sensitive troponin Т</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High-sensitive troponin Т dynamics</measure>
    <time_frame>Change from baseline on day 15 during ICU treatment</time_frame>
    <description>High-sensitive troponin Т</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin D level</measure>
    <time_frame>Change from baseline on day 5 during ICU treatment</time_frame>
    <description>Vitamin D level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin D level dynamics</measure>
    <time_frame>Change from baseline on day 15 during ICU treatment</time_frame>
    <description>Vitamin D level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogram</measure>
    <time_frame>Change from baseline on day 5 during ICU treatment</time_frame>
    <description>Immunogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogram dynamics</measure>
    <time_frame>Change from baseline on day 15 during ICU treatment</time_frame>
    <description>Immunogram</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>SARS-CoV2</condition>
  <arm_group>
    <arm_group_label>Clinical Features of Severe Patients With COVID-19</arm_group_label>
    <description>Critical ill patients with COVID-19 admitted to the ICU. The demographic, clinical data, laboratory data, and Instrumental data will be analysed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>The demographic, clinical, laboratory, and instrumental data</intervention_name>
    <description>Measurement of the demographic, clinical data, laboratory data, and instrumental data</description>
    <arm_group_label>Clinical Features of Severe Patients With COVID-19</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with COVID-19 requiring respiratory support&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients with COVID-19 admitted to the ICU with invasive and noninvasive&#xD;
             ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 24 hours in ICU by any reason,&#xD;
&#xD;
          -  chronic decompensated diseases with extrapulmonary organ dysfunction (tumour&#xD;
             progression, liver cirrhosis, congestive heart failure),&#xD;
&#xD;
          -  atonic coma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tatiana V Klypa, Dr.Med.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal Research Clinical Center of Federal Medical &amp; Biological Agency</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal Research Clinical Center of Federal Medical &amp; Biological Agency</name>
      <address>
        <city>Moscow</city>
        <zip>115682</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <reference>
    <citation>Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.</citation>
    <PMID>32007143</PMID>
  </reference>
  <reference>
    <citation>Tian W, Jiang W, Yao J, Nicholson CJ, Li RH, Sigurslid HH, Wooster L, Rotter JI, Guo X, Malhotra R. Predictors of mortality in hospitalized COVID-19 patients: A systematic review and meta-analysis. J Med Virol. 2020 Oct;92(10):1875-1883. doi: 10.1002/jmv.26050. Epub 2020 Jul 11.</citation>
    <PMID>32441789</PMID>
  </reference>
  <reference>
    <citation>Paranjpe I, Russak AJ, De Freitas JK, Lala A, Miotto R, Vaid A, Johnson KW, Danieletto M, Golden E, Meyer D, Singh M, Somani S, Manna S, Nangia U, Kapoor A, O'Hagan R, O'Reilly PF, Huckins LM, Glowe P, Kia A, Timsina P, Freeman RM, Levin MA, Jhang J, Firpo A, Kovatch P, Finkelstein J, Aberg JA, Bagiella E, Horowitz CR, Murphy B, Fayad ZA, Narula J, Nestler EJ, Fuster V, Cordon-Cardo C, Charney DS, Reich DL, Just AC, Bottinger EP, Charney AW, Glicksberg BS, Nadkarni GN. Clinical Characteristics of Hospitalized Covid-19 Patients in New York City. medRxiv. 2020 Apr 26:2020.04.19.20062117. doi: 10.1101/2020.04.19.20062117. Preprint.</citation>
    <PMID>32511655</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>May 19, 2021</last_update_submitted>
  <last_update_submitted_qc>May 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS pneumonia</keyword>
  <keyword>COVID-19</keyword>
  <keyword>severe disease</keyword>
  <keyword>risk factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04450017
org study id: COVID-ICU
nct id: NCT04450017
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
As coronavirus disease 2019 (COVID-19) spreads across the world, the intensive care unit
      (ICU) community must prepare for the challenges associated with this pandemic. Providing an
      efficient care to the patients of the most severely affected category - intensive care unit
      (ICU) patients - has become one of the serious problems appearing in the COVID-19 pandemics.
      A typical patient's clinical portrait in ICU of COVID centers is very similar in different
      countries, however, the key to improve the treatment results for critically ill patients has
      not yet been found. Data on predictors of severe course in COVID-19 is limited. Knowledge of
      predictors of severe course of disease can lead to different selection of therapeutic
      strategy, determine the group of risk of patients for severe course of disease, and improve
      outcomes.
The clinical disease (COVID-19) results in critical illness in about 5% of patients. The aim
      of the study is to identify predictors of the severe pneumonia caused by the SARS-CoV-2
      virus, and to describe the clinical features of patients admitted to an ICU of the
      COVID-center of the Federal Research Clinical Center of Federal Medical & Biological Agency
      on the first day and in dynamics till discharge from the ICU or death.

      The demographic and clinical data will be collected. Laboratory data (hemoglobin,
      lymphocytes, neutrophil to lymphocyte ratio, D-dimer level, IL-6, procalcitonin, glucose
      level, high-sensitive troponin Т, vitamin D level, signs of the presence of a secondary
      bacterial infection, immunogram and Instrumental data (CT-scan, Electrocardiography,
      echocardiography, arterial and venous ultrasound investigation) will be analysed.

      This study is singlecentral observational trial.
observational model: Case-Only
time perspective: Retrospective
measure: Mechanical ventilation duration
time frame: 30 days
description: The amount of mechanical ventilation days
measure: Non-invasive Mechanical ventilation duration
time frame: 30 days
description: The amount of Non-invasive mechanical ventilation days
measure: Mortality
time frame: 60 days
description: The dead and survived patients ratio
measure: Сomplete blood count
time frame: Change from baseline on day 5 during ICU treatment
description: Сomplete blood count
measure: Biochemistry analysis
time frame: Change from baseline on day 5 during ICU treatment
description: Biochemistry analysis
measure: Сomplete blood count dynamics
time frame: Change from baseline on day 15 during ICU treatment
description: Сomplete blood count
measure: Biochemistry analysis dynamics
time frame: Change from baseline on day 15 during ICU treatment
description: Biochemistry analysis
measure: Computer tomography
time frame: Change from baseline on day 5 during ICU treatment
description: Computer tomography of lungs
measure: High-sensitive troponin Т
time frame: Change from baseline on day 5 during ICU treatment
description: High-sensitive troponin Т
measure: High-sensitive troponin Т dynamics
time frame: Change from baseline on day 15 during ICU treatment
description: High-sensitive troponin Т
measure: Vitamin D level
time frame: Change from baseline on day 5 during ICU treatment
description: Vitamin D level
measure: Vitamin D level dynamics
time frame: Change from baseline on day 15 during ICU treatment
description: Vitamin D level
measure: Immunogram
time frame: Change from baseline on day 5 during ICU treatment
description: Immunogram
measure: Immunogram dynamics
time frame: Change from baseline on day 15 during ICU treatment
description: Immunogram
arm group label: Clinical Features of Severe Patients With COVID-19
description: Critical ill patients with COVID-19 admitted to the ICU. The demographic, clinical data, laboratory data, and Instrumental data will be analysed.
intervention type: Diagnostic Test
intervention name: The demographic, clinical, laboratory, and instrumental data
description: Measurement of the demographic, clinical data, laboratory data, and instrumental data
arm group label: Clinical Features of Severe Patients With COVID-19
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Tatiana V Klypa, Dr.Med.Sc.
role: Principal Investigator
affiliation: Federal Research Clinical Center of Federal Medical & Biological Agency
facility: 
country: Russian Federation
citation: Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PMID: 32007143
citation: Tian W, Jiang W, Yao J, Nicholson CJ, Li RH, Sigurslid HH, Wooster L, Rotter JI, Guo X, Malhotra R. Predictors of mortality in hospitalized COVID-19 patients: A systematic review and meta-analysis. J Med Virol. 2020 Oct;92(10):1875-1883. doi: 10.1002/jmv.26050. Epub 2020 Jul 11.
PMID: 32441789
citation: Paranjpe I, Russak AJ, De Freitas JK, Lala A, Miotto R, Vaid A, Johnson KW, Danieletto M, Golden E, Meyer D, Singh M, Somani S, Manna S, Nangia U, Kapoor A, O'Hagan R, O'Reilly PF, Huckins LM, Glowe P, Kia A, Timsina P, Freeman RM, Levin MA, Jhang J, Firpo A, Kovatch P, Finkelstein J, Aberg JA, Bagiella E, Horowitz CR, Murphy B, Fayad ZA, Narula J, Nestler EJ, Fuster V, Cordon-Cardo C, Charney DS, Reich DL, Just AC, Bottinger EP, Charney AW, Glicksberg BS, Nadkarni GN. Clinical Characteristics of Hospitalized Covid-19 Patients in New York City. medRxiv. 2020 Apr 26:2020.04.19.20062117. doi: 10.1101/2020.04.19.20062117. Preprint.
PMID: 32511655
responsible party type: Sponsor
mesh term: COVID-19