<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/NCT04443712</url>
  </required_header>
  <id_info>
    <org_study_id>FMASU P29 /2020</org_study_id>
    <nct_id>NCT04443712</nct_id>
  </id_info>
  <brief_title>Screening for Patients Admitted to Ain-Shams University Hospitals for SARS-COV-2 (COVID19)</brief_title>
  <official_title>Screening for Patients Admitted to Ain-Shams University Hospitals for SARS-COV-2 (COVID19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samia Girgis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</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>
      The objective of this study is to screen the patients seeking hospitalization in Ain Shams&#xD;
      university hospitals and identify a cost effective tool for continuing screening the patients&#xD;
      all through the epidemic period&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study setting: Ain-Shams University Hospitals. It is a campus including the following main&#xD;
      hospitals: Gynecology and Obstetrics, Oncology, Pediatrics, Psychiatry, Internal Medicine,&#xD;
      surgical, cardiothoracic and Geriatrics.&#xD;
&#xD;
      Study population: All patients needing admission in Ain-Shams University Hospitals are&#xD;
      eligible for the study.&#xD;
&#xD;
      Sample size: There is no incidence data published till now. Only the confirmed detected cases&#xD;
      have been reported. We assumed that the community cases are around 10 times that of detected&#xD;
      cases.&#xD;
&#xD;
      it was estimated to be 1900 patients with 95% confidence level given the frequency of&#xD;
      positive screening 0.05% with precision ± 0.1%. 10&#xD;
&#xD;
      The patients will be enrolled in the study using consecutive sample till the sample size is&#xD;
      achieved.&#xD;
&#xD;
      Study methods:&#xD;
&#xD;
      Every enrolled patient will be subjected to:&#xD;
&#xD;
        1. An interview questionnaire including personal data ( age, gender, residence , contact&#xD;
           details ) , epidemiological data (history of contact to a COVID-19 case, History of&#xD;
           travel), clinical data history ( Fever, Cough, sore throat)&#xD;
&#xD;
        2. Reverse Transcription Polymerase Chain Reaction (RT-PCR)&#xD;
&#xD;
        3. Antibody IgM-IgG test for SARS-CoV-2&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      Data will be validated, cleaned and entered in spreadsheet. SPSS program will be used for&#xD;
      analysis.&#xD;
&#xD;
      Qualitative data will be presented in frequency and related percentage. Quantitative data&#xD;
      with normal distribution will be presented in mean and standard deviation or median and&#xD;
      interquartile for non-normally distributed data.&#xD;
&#xD;
      Incidence of positive screening test among the total will be calculated with 95% confidence&#xD;
      interval.&#xD;
&#xD;
      Comparison between groups will be done using relevant suitable parametric or non-parametric&#xD;
      tests. A &quot;P&quot; value of 0.05 is decided to be the level of significance.&#xD;
&#xD;
      Risk ratios will be calculated for estimation of risk with 95% confidence interval.&#xD;
&#xD;
      Cost per one positive detected screening test will be calculated (Total cost / total positive&#xD;
      cases). The direct and indirect costs will be calculated by the laboratory department.&#xD;
&#xD;
      Ethical considerations:&#xD;
&#xD;
      The protocol will be submitted for approval by the University Ethical Research Committee.&#xD;
&#xD;
      The objectives and methods of the research will be explained to the participants.&#xD;
&#xD;
      An informed consent will be obtained from subjects willing to participate in the research and&#xD;
      the subjects are free to withdraw from research anytime.&#xD;
&#xD;
      Confidentiality of the data will be highly secured. Positive cases will be reported to the&#xD;
      Ministry of Health and Population (MOHP). The guidelines of isolation and treatment protocol&#xD;
      of MOHP will be followed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 29, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of the new COVID19 among hospitalized patients</measure>
    <time_frame>12 months</time_frame>
    <description>To measure the incidence of the new SARS-COV-2 (COVID19) among patients seeking hospitalization to Ain-Shams University Hospitals</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost of screening hospitalized patients</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the cost of screening hospitalized patients</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1900</enrollment>
  <condition>Coronavirus Disease 2019 (COVID19)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients needing admission in Ain-Shams University Hospitals; which is a campus&#xD;
        including the following main hospitals: Gynecology and Obstetrics, Oncology, Pediatrics,&#xD;
        Psychiatry, Internal Medicine, surgical, cardiothoracic and Geriatrics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria - All hospitalized patients in Ain-Shams University Hospitals.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Those who refuse to participate in the trial&#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>Samia Girgis</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vice Director of ASU Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Samia Girgis</last_name>
    <phone>+20 122 336 6500</phone>
    <email>drsamia.girgis@med.asu.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center</name>
      <address>
        <city>Cairo</city>
        <state>Non-US</state>
        <zip>11566</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fatma Soliman E Ebeid</last_name>
      <phone>01095569596</phone>
      <email>dr.fatma_ebeid@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 20, 2020</last_update_submitted>
  <last_update_submitted_qc>June 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Samia Girgis</investigator_full_name>
    <investigator_title>vice director of ASU Hospitals</investigator_title>
  </responsible_party>
  <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>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/NCT04443712
org study id: FMASU P29 /2020
nct id: NCT04443712
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to screen the patients seeking hospitalization in Ain Shams
      university hospitals and identify a cost effective tool for continuing screening the patients
      all through the epidemic period
Study setting: Ain-Shams University Hospitals. It is a campus including the following main
      hospitals: Gynecology and Obstetrics, Oncology, Pediatrics, Psychiatry, Internal Medicine,
      surgical, cardiothoracic and Geriatrics.

      Study population: All patients needing admission in Ain-Shams University Hospitals are
      eligible for the study.

      Sample size: There is no incidence data published till now. Only the confirmed detected cases
      have been reported. We assumed that the community cases are around 10 times that of detected
      cases.

      it was estimated to be 1900 patients with 95% confidence level given the frequency of
      positive screening 0.05% with precision ± 0.1%. 10

      The patients will be enrolled in the study using consecutive sample till the sample size is
      achieved.

      Study methods:

      Every enrolled patient will be subjected to:

        1. An interview questionnaire including personal data ( age, gender, residence , contact
           details ) , epidemiological data (history of contact to a COVID-19 case, History of
           travel), clinical data history ( Fever, Cough, sore throat)

        2. Reverse Transcription Polymerase Chain Reaction (RT-PCR)

        3. Antibody IgM-IgG test for SARS-CoV-2

      Statistical analysis:

      Data will be validated, cleaned and entered in spreadsheet. SPSS program will be used for
      analysis.

      Qualitative data will be presented in frequency and related percentage. Quantitative data
      with normal distribution will be presented in mean and standard deviation or median and
      interquartile for non-normally distributed data.

      Incidence of positive screening test among the total will be calculated with 95% confidence
      interval.

      Comparison between groups will be done using relevant suitable parametric or non-parametric
      tests. A "P" value of 0.05 is decided to be the level of significance.

      Risk ratios will be calculated for estimation of risk with 95% confidence interval.

      Cost per one positive detected screening test will be calculated (Total cost / total positive
      cases). The direct and indirect costs will be calculated by the laboratory department.

      Ethical considerations:

      The protocol will be submitted for approval by the University Ethical Research Committee.

      The objectives and methods of the research will be explained to the participants.

      An informed consent will be obtained from subjects willing to participate in the research and
      the subjects are free to withdraw from research anytime.

      Confidentiality of the data will be highly secured. Positive cases will be reported to the
      Ministry of Health and Population (MOHP). The guidelines of isolation and treatment protocol
      of MOHP will be followed.
observational model: Cohort
time perspective: Cross-Sectional
measure: The incidence of the new COVID19 among hospitalized patients
time frame: 12 months
description: To measure the incidence of the new SARS-COV-2 (COVID19) among patients seeking hospitalization to Ain-Shams University Hospitals
measure: Cost of screening hospitalized patients
time frame: 12 months
description: To determine the cost of screening hospitalized patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Samia Girgis
role: Principal Investigator
affiliation: Vice Director of ASU Hospital
last name: Samia Girgis
phone: +20 122 336 6500
email: drsamia.girgis@med.asu.edu.eg
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Ain Shams University
investigator full name: Samia Girgis
investigator title: vice director of ASU Hospitals
mesh term: COVID-19
sharing ipd: No