<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/NCT04453748</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-19 Complications Study</org_study_id>
    <nct_id>NCT04453748</nct_id>
  </id_info>
  <brief_title>The Assessment of the Prevalence, Clinical Course and Treatment of COVID-19 Complications</brief_title>
  <official_title>The Assessment of the Prevalence, Clinical Course and Treatment of COVID-19 Complications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Silesian Centre for Heart Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Research Agency, Poland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of Silesia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Silesian Centre for Heart Diseases</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>
      SAR-Cov-2 infection and its clinical manifestation known as COVID-19 beside the respiratory&#xD;
      and lung involvement may include the cardiovascular system, the nervous system and the liver.&#xD;
      In the acute phase of the disease, all of these conditions may be life-threatened. As a&#xD;
      result, after the acute phase of COVID-19, early complications may be observed, including&#xD;
      heart, lungs, brain, muscles and liver. A few papers to date have been reported of&#xD;
      myocarditis, ventricular arrhythmias, post-inflammatory changes in the lung and liver, as&#xD;
      well as ischemic changes in the brain, diseases of skeletal muscle, which may have adverse&#xD;
      prognostic effects. Due to the extent of the pandemic, the severity of the complications and&#xD;
      the expected high complications' prevalence in the early post-recovery period, a study was&#xD;
      designed to determine the extent of the problem of early complications after COVID-19.&#xD;
      Complex cardiological, pulmonary, neurological and hepatological diagnostics are planned,&#xD;
      including laboratory, imaging and functional tests. The results obtained, in addition to&#xD;
      determining the scale of the problem, will allow the selection of studies that optimally&#xD;
      identify patients with early complications. The purpose of this procedure is to enable rapid&#xD;
      treatment of diseases that are complications of SARS-COV-2 infection. An additional aspect&#xD;
      raised in the project will be the issue of psychiatric disorders (anxiety, depression, post&#xD;
      traumatic disorders).&#xD;
&#xD;
      The main three purposes of the study include:&#xD;
&#xD;
        1. the assessment of prevalence of particular complications after COVID-19.&#xD;
&#xD;
        2. identification of the demographic and clinical risk factors of COVID-19 complications&#xD;
&#xD;
        3. determining the diagnostic tests which are sufficient to detect early complications of&#xD;
           COVID-19&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 31, 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>2 Months</target_duration>
  <primary_outcome>
    <measure>Prevalence of COVID-19 complications</measure>
    <time_frame>2 months</time_frame>
    <description>Complications include pulmonary, cardio-vascular, neurological, hepatologic and psychiatric disordes that might be linked to the COVID-19.&#xD;
The diagnostic tests: blood tests, transthoracic echocardiography, spirometry, high-resolution computed tomography, neurological examination, liver ultrasonography and elastography, vasular ultrasonography (veins and arteries), psychiatric questionnairies</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of risk factors of COVID-19 complications</measure>
    <time_frame>2 months</time_frame>
    <description>Analysis which demographic and clinical parametrs were associated with particular COVID-19 complication.&#xD;
Statistical analysis of relation between clinical parameters before and during COVID19 and the occurence of COVID19 complications</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>COVID-19</condition>
  <condition>Coronavirus Infection</condition>
  <condition>Sars-CoV2</condition>
  <condition>Complications</condition>
  <arm_group>
    <arm_group_label>COVID-19 convalescents</arm_group_label>
    <description>People who recovered from COVID-19: have no symptoms and no SARS-Cov2 RNA in PCR</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Complex diagnostic panel</intervention_name>
    <description>Complex, multidisciplinary diagnostic panel, including blood, imaging and functional tests.</description>
    <arm_group_label>COVID-19 convalescents</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who recovered from COVID-19 in Silesia, Poland.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. SARS-Cov-2 RNA confirmed by the PCR method in the acute phase of disease.&#xD;
&#xD;
          2. Presence of the clinical symptoms associated with COVID-19 in the acute phase of&#xD;
             disease&#xD;
&#xD;
          3. Two negative results of SARS-COV-2 PCR test following the 7-day period of quarantine&#xD;
&#xD;
          4. Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any symptoms of infection during the quarantine&#xD;
&#xD;
          2. Lack of patient's consent&#xD;
&#xD;
          3. Lack of possibility of travelling to the hospital for tests&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Silesian Centre for Heart Disease</name>
      <address>
        <city>Zabrze</city>
        <state>Silesia</state>
        <zip>41-800</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>September 28, 2020</last_update_submitted>
  <last_update_submitted_qc>September 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Silesian Centre for Heart Diseases</investigator_affiliation>
    <investigator_full_name>Mariusz Gasior</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Sars-CoV2</keyword>
  <keyword>Complications</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>Disease Progression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04453748
org study id: COVID-19 Complications Study
nct id: NCT04453748
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
SAR-Cov-2 infection and its clinical manifestation known as COVID-19 beside the respiratory
      and lung involvement may include the cardiovascular system, the nervous system and the liver.
      In the acute phase of the disease, all of these conditions may be life-threatened. As a
      result, after the acute phase of COVID-19, early complications may be observed, including
      heart, lungs, brain, muscles and liver. A few papers to date have been reported of
      myocarditis, ventricular arrhythmias, post-inflammatory changes in the lung and liver, as
      well as ischemic changes in the brain, diseases of skeletal muscle, which may have adverse
      prognostic effects. Due to the extent of the pandemic, the severity of the complications and
      the expected high complications' prevalence in the early post-recovery period, a study was
      designed to determine the extent of the problem of early complications after COVID-19.
      Complex cardiological, pulmonary, neurological and hepatological diagnostics are planned,
      including laboratory, imaging and functional tests. The results obtained, in addition to
      determining the scale of the problem, will allow the selection of studies that optimally
      identify patients with early complications. The purpose of this procedure is to enable rapid
      treatment of diseases that are complications of SARS-COV-2 infection. An additional aspect
      raised in the project will be the issue of psychiatric disorders (anxiety, depression, post
      traumatic disorders).

      The main three purposes of the study include:

        1. the assessment of prevalence of particular complications after COVID-19.

        2. identification of the demographic and clinical risk factors of COVID-19 complications

        3. determining the diagnostic tests which are sufficient to detect early complications of
           COVID-19
observational model: Cohort
time perspective: Prospective
measure: Prevalence of COVID-19 complications
time frame: 2 months
description: Complications include pulmonary, cardio-vascular, neurological, hepatologic and psychiatric disordes that might be linked to the COVID-19.
The diagnostic tests: blood tests, transthoracic echocardiography, spirometry, high-resolution computed tomography, neurological examination, liver ultrasonography and elastography, vasular ultrasonography (veins and arteries), psychiatric questionnairies
measure: Assessment of risk factors of COVID-19 complications
time frame: 2 months
description: Analysis which demographic and clinical parametrs were associated with particular COVID-19 complication.
Statistical analysis of relation between clinical parameters before and during COVID19 and the occurence of COVID19 complications
arm group label: COVID-19 convalescents
description: People who recovered from COVID-19: have no symptoms and no SARS-Cov2 RNA in PCR
intervention type: Other
intervention name: Complex diagnostic panel
description: Complex, multidisciplinary diagnostic panel, including blood, imaging and functional tests.
arm group label: COVID-19 convalescents
Blood, urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Silesian Centre for Heart Diseases
investigator full name: Mariusz Gasior
investigator title: Prof.
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Disease Progression
sharing ipd: Undecided