<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/NCT04488588</url>
  </required_header>
  <id_info>
    <org_study_id>AssiutU17</org_study_id>
    <nct_id>NCT04488588</nct_id>
  </id_info>
  <brief_title>Survival and 30-days Hospital Outcome in COVID-19 Patients in Upper Egypt</brief_title>
  <official_title>Survival and 30-days Hospital Outcome in Hospitalized COVID-19 Patients in Upper Egypt: Multi-center Study</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>
      Through history, there have been plenty of pandemics however; the social response to corona&#xD;
      virus disease (COVID-19) is unparalleled. It is assessed that almost four billion individuals&#xD;
      are living in social segregation during this mother of all pandemics.&#xD;
&#xD;
      Initially described in China in December 2019, severe acute respiratory syndrome caused by&#xD;
      corona virus 2 (SARS-CoV-2) has spread all over the world and by 18th July 2020- there was an&#xD;
      emergent figure of 13,824,739 confirmed cases and 591.666 losses reported to the WHO. To&#xD;
      date, Egypt reported slightly over 82,000 confirmed COVID-19 cases with 3858 deaths. The new&#xD;
      pandemic is injuring not only health organizations of several countries but also the&#xD;
      financial prudence universal.&#xD;
&#xD;
      Defining the clinical features and associated outcomes of patients diagnosed with coronavirus&#xD;
      disease (COVID-19) is fundamental to improving our understanding and adequate management of&#xD;
      this illness. Several articles have recently been published, describing the clinical features&#xD;
      and outcomes of retrospective individuals with COVID-19&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2020</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>number of co-morbidities in hospitalized patients with COVID-19</measure>
    <time_frame>one month</time_frame>
    <description>Determinants of survival in studied covid-19 patients admitted to hospitals</description>
  </primary_outcome>
  <primary_outcome>
    <measure>causes of ICU admission</measure>
    <time_frame>one month</time_frame>
    <description>Determinants of ICU admission in hospitalized patients with COVID-19</description>
  </primary_outcome>
  <enrollment type="Actual">1064</enrollment>
  <condition>Covid19</condition>
  <condition>Coronavirus Disease</condition>
  <condition>SARS-CoV-2</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kaplan Meier analysis</intervention_name>
    <description>Kaplan Meier survival analysis was conducted to calculate the cumulative overall survival rates using Log Rank test for comparison between age groups</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All cases had confirmed COVID-19 infection (based on PCR, chest HRCT, CBC, CRP, Ferritin&#xD;
        levels) and received standardized treatment protocols of Ministry of Health and Population&#xD;
        based on disease severity.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  This study included 1064 patients consecutively admitted to isolation hospitals in&#xD;
             Upper Egypt during the period from 22 March to 23 June 2020&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  only hospitalized confirmed cases of COVID-19 were included.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>36 Years</minimum_age>
    <maximum_age>63 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Aliae Mohamed-Hussein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AssiutU</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aliae Mohamed-Hussein</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 25, 2020</last_update_submitted>
  <last_update_submitted_qc>July 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 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>COVID-19</keyword>
  <keyword>Survival</keyword>
  <keyword>30- Days Hospital outcome</keyword>
  <keyword>outcome</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/NCT04488588
org study id: AssiutU17
nct id: NCT04488588
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Through history, there have been plenty of pandemics however; the social response to corona
      virus disease (COVID-19) is unparalleled. It is assessed that almost four billion individuals
      are living in social segregation during this mother of all pandemics.

      Initially described in China in December 2019, severe acute respiratory syndrome caused by
      corona virus 2 (SARS-CoV-2) has spread all over the world and by 18th July 2020- there was an
      emergent figure of 13,824,739 confirmed cases and 591.666 losses reported to the WHO. To
      date, Egypt reported slightly over 82,000 confirmed COVID-19 cases with 3858 deaths. The new
      pandemic is injuring not only health organizations of several countries but also the
      financial prudence universal.

      Defining the clinical features and associated outcomes of patients diagnosed with coronavirus
      disease (COVID-19) is fundamental to improving our understanding and adequate management of
      this illness. Several articles have recently been published, describing the clinical features
      and outcomes of retrospective individuals with COVID-19
observational model: Cohort
time perspective: Retrospective
measure: number of co-morbidities in hospitalized patients with COVID-19
time frame: one month
description: Determinants of survival in studied covid-19 patients admitted to hospitals
measure: causes of ICU admission
time frame: one month
description: Determinants of ICU admission in hospitalized patients with COVID-19
intervention type: Other
intervention name: Kaplan Meier analysis
description: Kaplan Meier survival analysis was conducted to calculate the cumulative overall survival rates using Log Rank test for comparison between age groups
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 36 Years
maximum age: 63 Years
last name: Aliae Mohamed-Hussein, MD
role: Principal Investigator
affiliation: Assiut University
facility: 
facility: 
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