<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/NCT04479293</url>
  </required_header>
  <id_info>
    <org_study_id>AssiutU16</org_study_id>
    <nct_id>NCT04479293</nct_id>
  </id_info>
  <brief_title>Post COVID-19 Functional Status in Egypt</brief_title>
  <official_title>Assessment of Functional Recovery From COVID-19 Using the Proposed Post- COVID-19 Functional Status Score</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Since the outbreak of coronavirus disease - COVID-19 pandemic, most attention has focused on&#xD;
      mode of transmission, clinical picture of the disease, treatment and prevention. In the&#xD;
      coming weeks and months emphasis will gradually involve the post- acute care of COVID-19&#xD;
      survivors. It is anticipated that COVID-19 may have major impact on physical, cognitive,&#xD;
      mental, social health status even in patients with mild disease. Moreover, pulmonary,&#xD;
      radiologic, laboratory, sleep issues remain to be addressed&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 30, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>number of functional limitations post COVID-19</measure>
    <time_frame>3-6 month</time_frame>
    <description>scale 0-64 points</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of psychologic changes</measure>
    <time_frame>3-6 months</time_frame>
    <description>Hamilton scale, points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Disturbance and quality</measure>
    <time_frame>3-6 months</time_frame>
    <description>ESS scale 0-20, points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiologic changes</measure>
    <time_frame>3-6 months</time_frame>
    <description>Chest HRCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory changes</measure>
    <time_frame>3-6 moths</time_frame>
    <description>Complete blood count, C - reactive protein, serum ferritin</description>
  </secondary_outcome>
  <enrollment type="Anticipated">400</enrollment>
  <condition>COVID-19</condition>
  <condition>Coronavirus Disease</condition>
  <condition>SARS-CoV-2</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Post COVID-19 Functional Satus Scale</intervention_name>
    <description>scale from 0-64 assessing functional limitation</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients diagnosed as COVID-19 on clinical, laboratory, radiologic or PCR based are&#xD;
        included.&#xD;
&#xD;
        Patients with different severity mild, moderate, severe , managed at home or in hospitals&#xD;
        are included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All confirmed cases with COVID-19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non COVID-19 cases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aliae Mohamed-Hussein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aliae Mohamed-Hussein</last_name>
    <phone>01222302352</phone>
    <email>aliaehussein@aun.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Aliaa Hussein</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aliaa AR Hussein</last_name>
      <phone>+201222302352</phone>
      <email>aliaehussein@aun.edu.eg</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>September 7, 2020</last_update_submitted>
  <last_update_submitted_qc>September 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Aliae AR Mohamed Hussein</investigator_full_name>
    <investigator_title>Professor of Pulmonology</investigator_title>
  </responsible_party>
  <keyword>Functional score</keyword>
  <keyword>Radiologic changes</keyword>
  <keyword>Psychologic changes</keyword>
  <keyword>Laboratory</keyword>
  <keyword>Sleep disturbance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04479293
org study id: AssiutU16
nct id: NCT04479293
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Since the outbreak of coronavirus disease - COVID-19 pandemic, most attention has focused on
      mode of transmission, clinical picture of the disease, treatment and prevention. In the
      coming weeks and months emphasis will gradually involve the post- acute care of COVID-19
      survivors. It is anticipated that COVID-19 may have major impact on physical, cognitive,
      mental, social health status even in patients with mild disease. Moreover, pulmonary,
      radiologic, laboratory, sleep issues remain to be addressed
observational model: Cohort
time perspective: Prospective
measure: number of functional limitations post COVID-19
time frame: 3-6 month
description: scale 0-64 points
measure: number of psychologic changes
time frame: 3-6 months
description: Hamilton scale, points
measure: Sleep Disturbance and quality
time frame: 3-6 months
description: ESS scale 0-20, points
measure: Radiologic changes
time frame: 3-6 months
description: Chest HRCT
measure: Laboratory changes
time frame: 3-6 moths
description: Complete blood count, C - reactive protein, serum ferritin
intervention type: Other
intervention name: Post COVID-19 Functional Satus Scale
description: scale from 0-64 assessing functional limitation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Aliae Mohamed-Hussein, MD
role: Principal Investigator
affiliation: Assiut University
last name: Aliae Mohamed-Hussein
phone: 01222302352
email: aliaehussein@aun.edu.eg
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Aliae AR Mohamed Hussein
investigator title: Professor of Pulmonology
mesh term: COVID-19
sharing ipd: Undecided