<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/NCT04492384</url>
  </required_header>
  <id_info>
    <org_study_id>ACTIV11062020</org_study_id>
    <nct_id>NCT04492384</nct_id>
  </id_info>
  <brief_title>Analysis of Chronic Non-infectious Diseases Dynamics After COVID-19 Infection in Adult Patients</brief_title>
  <acronym>ACTIV</acronym>
  <official_title>Analysis of Chronic Non-infectious Diseases Dynamics After COVID-19 Infection in Adult Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eurasian Association of Therapists</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eurasian Association of Therapists</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>
      Non-commercial depersonalized multi-centered registry study on analysis of chronic&#xD;
      non-infectious diseases dynamics after SARS-CoV-2 infection in adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-commercial depersonalized multi-centered registry study on analysis of chronic&#xD;
      non-infectious diseases dynamics after SARS-CoV-2 infection in cohort of Russian adult&#xD;
      patients.&#xD;
&#xD;
      Retrospective analysis of medical histories and outcomes in adults with pre-existing&#xD;
      conditions after SARS-CoV-2 infection and prospective monitoring of health status during 3, 6&#xD;
      and 12 months after discharge. Comorbidities worsening risk factors measuring through&#xD;
      evaluation of range of indicators such as dynamics of diabetes, CKD, COPD, bronchial astma,&#xD;
      incidence of hypertonic crises, vascular events and others.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Actual">November 29, 2021</completion_date>
  <primary_completion_date type="Actual">November 29, 2020</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>rate of non-infectious diseases</measure>
    <time_frame>12 month since a moment of request of medical help</time_frame>
    <description>percentage of patients with non-infectious diseases relating to overall number of patients registered in study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>severity of COVID-19 depending on pre-existing diseases</measure>
    <time_frame>12 month since a moment of request of medical help</time_frame>
    <description>correlation between number of patients with COVID-19 of various severity and number of pre-existing conditions and their severity among these groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>disability registration / change of disability status</measure>
    <time_frame>12 month since a moment of request of medical help</time_frame>
    <description>Registration of disability or change of disability status</description>
  </primary_outcome>
  <primary_outcome>
    <measure>rate of letal outcomes</measure>
    <time_frame>12 month since a moment of request of medical help</time_frame>
    <description>rate of deaths among registered participants</description>
  </primary_outcome>
  <primary_outcome>
    <measure>rate of letal outcomes depending on pre-existing disease</measure>
    <time_frame>12 month since a moment of request of medical help</time_frame>
    <description>correlation between number of deaths and pre-existing diseases</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">6396</enrollment>
  <condition>Covid19</condition>
  <condition>SARS-CoV-2 Infection</condition>
  <condition>Pneumonia</condition>
  <condition>Copd</condition>
  <condition>CKD</condition>
  <condition>Cardiac Event</condition>
  <condition>Overweight and Obesity</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Diabetes</condition>
  <condition>Hypertension</condition>
  <condition>Coronary Heart Disease</condition>
  <arm_group>
    <arm_group_label>inpatients</arm_group_label>
    <description>Patients treated from COVID-19 in hospital</description>
  </arm_group>
  <arm_group>
    <arm_group_label>outpatients</arm_group_label>
    <description>Patients treated from COVID-19 at home</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non-interventional</intervention_name>
    <description>Interview on health conditions</description>
    <arm_group_label>inpatients</arm_group_label>
    <arm_group_label>outpatients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Anonymized male and female patients over 18 years infected COVID-19 recieved inpatient or&#xD;
        outpatient care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspected or confirmed COVID-19.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refuse to be involved in study;&#xD;
&#xD;
          -  Age under 18 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Alexander Arutyunov, professor</last_name>
    <role>Study Chair</role>
    <affiliation>Eurasian Association of Therapists</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eurasian Association of Therapists</name>
      <address>
        <city>Moscow</city>
        <zip>101000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <link>
    <url>https://russjcardiol.elpub.ru/jour/article/view/4165</url>
    <description>results of the first interim statistical analysis (1000 patients)</description>
  </link>
  <link>
    <url>https://lib.ossn.ru/jour/article/view/1519</url>
    <description>study design</description>
  </link>
  <link>
    <url>http://russjcardiol.elpub.ru/jour/article/view/4358/</url>
    <description>design of observatinal studies &quot;Analysis of Chronic Non-infectious Diseases Dynamics After COVID-19 Infection in Adult Patients&quot; and &quot;Analysis of Health Status of Сomorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection&quot;</description>
  </link>
  <link>
    <url>http://russjcardiol.elpub.ru/jour/article/view/4470?locale=ru_RU</url>
    <description>Analysis of predictors of short-term adverse outcomes in COVID-19. Data from the international ACTIV SARS-CoV-2 registry</description>
  </link>
  <link>
    <url>http://lib.ossn.ru/jour/article/view/1680</url>
    <description>Analysis of influence of background therapy for comorbidities in the period before infection on the risk of the lethal COVID outcome. Data from the international ACTIV SARS-CoV-2 registry</description>
  </link>
  <link>
    <url>http://russjcardiol.elpub.ru/jour/article/view/4708</url>
    <description>Clinical features of post-COVID period. Results of an international registry &quot;ACTIV SARS-CoV-2&quot;. Preliminary data. (6 month follow-up)</description>
  </link>
  <link>
    <url>https://ter-arkhiv.ru/0040-3660/article/view/71639</url>
    <description>Assessment of impact of combined original comorbid diseases in patients with COVID-19 on the prognosis</description>
  </link>
  <link>
    <url>https://russjcardiol.elpub.ru/jour/article/view/4855</url>
    <description>Comparative analysis of echocardiographic and electrocardiographic data of survivors and deceased patients with COVID-19 (sub-analysis of the international register &quot;Dynamics analysis of comorbidities in SARS-CoV-2 survivors&quot;)</description>
  </link>
  <link>
    <url>https://russjcardiol.elpub.ru/jour/article/view/5042</url>
    <description>Lipid profile in hospitalized patients with COVID-19 depending on the outcome of its acute phase: data from the international registry &quot;Dynamics analysis of comorbidities in SARS-CoV-2 infection survivors&quot;</description>
  </link>
  <link>
    <url>https://www.probl-endojournals.ru/jour/article/view/13175</url>
    <description>The impact of carbohydrate metabolism disorders on the early and long-term clinical outcomes of patients with COVID-19 according to the AKTIV and AKTIV 2 registries.</description>
  </link>
  <link>
    <url>https://www.medarhive.ru/jour/issue/view/73/showToc</url>
    <description>Impact of Kidney Damage on the Course and Prognosis of COVID-19 Infection According to the International Registry &quot;Analysis of Chronic Non-Infectious Diseases Dynamics After Covid-19 Infection in Adult Patients&quot;</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/36519220/</url>
    <description>Impact of heart failure on all-cause mortality in COVID-19: findings from the Eurasian International Registry</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eurasian Association of Therapists</investigator_affiliation>
    <investigator_full_name>Tamara Kriukova</investigator_full_name>
    <investigator_title>Head of Organizational Committee</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Noncommunicable 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/NCT04492384
org study id: ACTIV11062020
nct id: NCT04492384
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Non-commercial depersonalized multi-centered registry study on analysis of chronic
      non-infectious diseases dynamics after SARS-CoV-2 infection in adults.
Non-commercial depersonalized multi-centered registry study on analysis of chronic
      non-infectious diseases dynamics after SARS-CoV-2 infection in cohort of Russian adult
      patients.

      Retrospective analysis of medical histories and outcomes in adults with pre-existing
      conditions after SARS-CoV-2 infection and prospective monitoring of health status during 3, 6
      and 12 months after discharge. Comorbidities worsening risk factors measuring through
      evaluation of range of indicators such as dynamics of diabetes, CKD, COPD, bronchial astma,
      incidence of hypertonic crises, vascular events and others.
observational model: Cohort
time perspective: Other
measure: rate of non-infectious diseases
time frame: 12 month since a moment of request of medical help
description: percentage of patients with non-infectious diseases relating to overall number of patients registered in study
measure: severity of COVID-19 depending on pre-existing diseases
time frame: 12 month since a moment of request of medical help
description: correlation between number of patients with COVID-19 of various severity and number of pre-existing conditions and their severity among these groups
measure: disability registration / change of disability status
time frame: 12 month since a moment of request of medical help
description: Registration of disability or change of disability status
measure: rate of letal outcomes
time frame: 12 month since a moment of request of medical help
description: rate of deaths among registered participants
measure: rate of letal outcomes depending on pre-existing disease
time frame: 12 month since a moment of request of medical help
description: correlation between number of deaths and pre-existing diseases
arm group label: inpatients
description: Patients treated from COVID-19 in hospital
arm group label: outpatients
description: Patients treated from COVID-19 at home
intervention type: Other
intervention name: non-interventional
description: Interview on health conditions
arm group label: inpatients
arm group label: outpatients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Alexander Arutyunov, professor
role: Study Chair
affiliation: Eurasian Association of Therapists
facility: 
country: Russian Federation
url: https://russjcardiol.elpub.ru/jour/article/view/4165
description: results of the first interim statistical analysis (1000 patients)
url: https://lib.ossn.ru/jour/article/view/1519
description: study design
url: http://russjcardiol.elpub.ru/jour/article/view/4358/
description: design of observatinal studies "Analysis of Chronic Non-infectious Diseases Dynamics After COVID-19 Infection in Adult Patients" and "Analysis of Health Status of Сomorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection"
url: http://russjcardiol.elpub.ru/jour/article/view/4470?locale=ru_RU
description: Analysis of predictors of short-term adverse outcomes in COVID-19. Data from the international ACTIV SARS-CoV-2 registry
url: http://lib.ossn.ru/jour/article/view/1680
description: Analysis of influence of background therapy for comorbidities in the period before infection on the risk of the lethal COVID outcome. Data from the international ACTIV SARS-CoV-2 registry
url: http://russjcardiol.elpub.ru/jour/article/view/4708
description: Clinical features of post-COVID period. Results of an international registry "ACTIV SARS-CoV-2". Preliminary data. (6 month follow-up)
url: https://ter-arkhiv.ru/0040-3660/article/view/71639
description: Assessment of impact of combined original comorbid diseases in patients with COVID-19 on the prognosis
url: https://russjcardiol.elpub.ru/jour/article/view/4855
description: Comparative analysis of echocardiographic and electrocardiographic data of survivors and deceased patients with COVID-19 (sub-analysis of the international register "Dynamics analysis of comorbidities in SARS-CoV-2 survivors")
url: https://russjcardiol.elpub.ru/jour/article/view/5042
description: Lipid profile in hospitalized patients with COVID-19 depending on the outcome of its acute phase: data from the international registry "Dynamics analysis of comorbidities in SARS-CoV-2 infection survivors"
url: https://www.probl-endojournals.ru/jour/article/view/13175
description: The impact of carbohydrate metabolism disorders on the early and long-term clinical outcomes of patients with COVID-19 according to the AKTIV and AKTIV 2 registries.
url: https://www.medarhive.ru/jour/issue/view/73/showToc
description: Impact of Kidney Damage on the Course and Prognosis of COVID-19 Infection According to the International Registry "Analysis of Chronic Non-Infectious Diseases Dynamics After Covid-19 Infection in Adult Patients"
url: https://pubmed.ncbi.nlm.nih.gov/36519220/
description: Impact of heart failure on all-cause mortality in COVID-19: findings from the Eurasian International Registry
responsible party type: Principal Investigator
investigator affiliation: Eurasian Association of Therapists
investigator full name: Tamara Kriukova
investigator title: Head of Organizational Committee
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19
mesh term: Cardiovascular Diseases
mesh term: Coronary Disease
mesh term: Overweight
mesh term: Noncommunicable Diseases
sharing ipd: No