xml: <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/NCT06022211</url>
    </required_header>
    <id_info>
      <org_study_id>ANRS 0268s POSTCOVIET</org_study_id>
      <nct_id>NCT06022211</nct_id>
    </id_info>
    <brief_title>Post-COVID-19 Condition: Observational Study in Vietnam</brief_title>
    <official_title>Post-COVID-19 Condition: Observational Study in Vietnam</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ANRS, Emerging Infectious Diseases</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ANRS, Emerging Infectious 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>
        The primary objective of this study is to estimate the prevalence of the post-COVID-19&#xD;
        condition in confirmed mild, moderate, and severe COVID-19 adult patients in Hai Phong,&#xD;
        Vietnam.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It is a cross-sectional study implemented in Hai Phong (Vietnam) by the Infectious and&#xD;
        Tropical Diseases Department of Viet Tiep 2 hospital and the Department of Public Health of&#xD;
        the Hai Phong University of Medicine and Pharmacy (HPMU).&#xD;
  &#xD;
        The aim is to enroll moderate and severe COVID-19 patients from the 2 following provincial&#xD;
        hospitals, Viet Tiep hospital and Kien An hospital, and mild COVID-19 patients from the&#xD;
        community level in Hai Phong to assess the burden of post-COVID-19 condition in each patient&#xD;
        group (mild, moderate or severe acute COVID-19).&#xD;
  &#xD;
        835 participants are aimed to be interviewed through phone calls: 196 participants with mild&#xD;
        disease, 289 participants with moderate disease, and 350 participants with severe disease. In&#xD;
        case of suspected post-COVID-19 condition, the participant will be proposed to come to Viet&#xD;
        Tiep 2 hospital for a study visit i) to confirm the post-COVID-19 condition, ii) to describe&#xD;
        symptoms, iii) to evaluate the functional limitations related to the post-COVID-19 condition,&#xD;
        and iv) to assess the determinants of the post-COVID-19 condition in patients with mild,&#xD;
        moderate, and severe acute COVID-19.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The primary endpoint is the proportion of participants who present a post-COVID-19 condition in adult patients with confirmed mild, moderate, and severe COVID-19 in Hai Phong, Vietnam.</measure>
      <time_frame>Day 0</time_frame>
      <description>According to the WHO definition</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Type and frequency of symptoms of the post-COVID-19 condition.</measure>
      <time_frame>Day 0</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional limitations among participants with the post-COVID-19 condition.</measure>
      <time_frame>Day 0</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Factors related to occurrence of post-COVID-19 condition in adults after mild, moderate, and severe acute COVID-19.</measure>
      <time_frame>Day 0</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">835</enrollment>
    <condition>Post COVID-19 Condition</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        -  1 EDTA tube of 2 mL for complete blood count;&#xD;
  &#xD;
          -  1 heparinate tube of 2 mL for the biochemistry tests including glycaemia, transaminases,&#xD;
             serum creatinine, CRP, ionogram (Na, K);&#xD;
  &#xD;
          -  1 EDTA tube of 2 mL for biobank (DBS and plasma).&#xD;
  &#xD;
          -  1 dry tube of 2 mL for HIV serology, HCV Ab, HBs Ag;&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          The patients hospitalised in Viet Tiep 2 hospital or Kien An hospital for moderate or&#xD;
          severe acute COVID-19 3 to 12 months before inclusion, or registered in the provincial CDC&#xD;
          database for mild COVID-19 that occurred 3-12 months before inclusion.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults aged 18 years or more;&#xD;
  &#xD;
            -  With a history of documented COVID-19 as confirmed by either a positive SARS-CoV-2&#xD;
               RT-PCR or antigenic test, 3-12 months before inclusion;&#xD;
  &#xD;
            -  Hospitalised in Viet Tiep 2 hospital or Kien An hospital (tertiary care hospitals)&#xD;
               with moderate or severe COVID-19 or registered in provincial CDC health system for&#xD;
               mild COVID-19;&#xD;
  &#xD;
            -  Accepting to participate in the study;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not able to understand or answer a quick phone questionnaire;&#xD;
  &#xD;
            -  Individuals who refuse or cannot come to Viet Tiep 2 hospital in case of the suspected&#xD;
               post-COVID-19 condition.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</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>Disease</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06022211
  org study id: ANRS 0268s POSTCOVIET
  nct id: NCT06022211
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The primary objective of this study is to estimate the prevalence of the post-COVID-19
        condition in confirmed mild, moderate, and severe COVID-19 adult patients in Hai Phong,
        Vietnam.
  It is a cross-sectional study implemented in Hai Phong (Vietnam) by the Infectious and
        Tropical Diseases Department of Viet Tiep 2 hospital and the Department of Public Health of
        the Hai Phong University of Medicine and Pharmacy (HPMU).
  
        The aim is to enroll moderate and severe COVID-19 patients from the 2 following provincial
        hospitals, Viet Tiep hospital and Kien An hospital, and mild COVID-19 patients from the
        community level in Hai Phong to assess the burden of post-COVID-19 condition in each patient
        group (mild, moderate or severe acute COVID-19).
  
        835 participants are aimed to be interviewed through phone calls: 196 participants with mild
        disease, 289 participants with moderate disease, and 350 participants with severe disease. In
        case of suspected post-COVID-19 condition, the participant will be proposed to come to Viet
        Tiep 2 hospital for a study visit i) to confirm the post-COVID-19 condition, ii) to describe
        symptoms, iii) to evaluate the functional limitations related to the post-COVID-19 condition,
        and iv) to assess the determinants of the post-COVID-19 condition in patients with mild,
        moderate, and severe acute COVID-19.
  observational model: Other
  time perspective: Cross-Sectional
  measure: The primary endpoint is the proportion of participants who present a post-COVID-19 condition in adult patients with confirmed mild, moderate, and severe COVID-19 in Hai Phong, Vietnam.
  time frame: Day 0
  description: According to the WHO definition
  measure: Type and frequency of symptoms of the post-COVID-19 condition.
  time frame: Day 0
  measure: Functional limitations among participants with the post-COVID-19 condition.
  time frame: Day 0
  measure: Factors related to occurrence of post-COVID-19 condition in adults after mild, moderate, and severe acute COVID-19.
  time frame: Day 0
  -  1 EDTA tube of 2 mL for complete blood count;
  
          -  1 heparinate tube of 2 mL for the biochemistry tests including glycaemia, transaminases,
             serum creatinine, CRP, ionogram (Na, K);
  
          -  1 EDTA tube of 2 mL for biobank (DBS and plasma).
  
          -  1 dry tube of 2 mL for HIV serology, HCV Ab, HBs Ag;
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: COVID-19
  mesh term: Disease