<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/NCT04490772</url>
  </required_header>
  <id_info>
    <org_study_id>COVID gastro intestinal</org_study_id>
    <nct_id>NCT04490772</nct_id>
  </id_info>
  <brief_title>Characteristics and Outcomes of Gastrointestinal Manifestations of COVID-19</brief_title>
  <official_title>Characteristics and Outcomes of Gastrointestinal Manifestations of COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients confirmed COVID-19 with gastrointestinal manifestations will be included.&#xD;
      Characteristics and outcomes will be described for them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients diagnosed as confirmed Covid-19 according to WHO and Egyptian Ministry of Health and&#xD;
      Population (MOH) definitions will be included.The following will be done for all patients:&#xD;
&#xD;
      Demographic characters; age, sex, presence of co-morbidities such as hypretension, diabetes&#xD;
      mellitus, obstructive lung diseases, ischemic heart diseases...etc, history of contact to&#xD;
      covid-19 patients or recent travelling abroad.Clinical Characteristics: By recording of&#xD;
      clinical manifestation such as fever, cough, shortness of breath, sore throat, change in&#xD;
      taste or smell, nausea,vomiting and diarrhea will be done. Complications and the type of&#xD;
      treatment received by the patients will also be described including mechanical ventilation.&#xD;
&#xD;
      Laboratory data will also be included : blood picture, liver enzymes, ESR,CRP, serum&#xD;
      ferritin, D-dimer and troponin.&#xD;
&#xD;
      Follow up of the patients will be done until improvement, deaths or complications to&#xD;
      determine disease outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 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>Clinical data questionnaire</measure>
    <time_frame>2 months</time_frame>
    <description>Clinical characteristics of age, sex, comorbidities and symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tests such as CBC</measure>
    <time_frame>2 months</time_frame>
    <description>Laboratory characters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>liver function test</measure>
    <time_frame>2 months</time_frame>
    <description>Laboratory characters</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Infectious</condition>
  <arm_group>
    <arm_group_label>Patients with Covid-19</arm_group_label>
    <description>COVID-19 patients presented with gastrointestinal manifestations</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Laboratory tests</intervention_name>
    <description>Laboratory tests such as CBC, Liver function and CRP</description>
    <arm_group_label>Patients with Covid-19</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Confirmed Covid-19 with GIT manifestations&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed Covid-19 with GIT manifestations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients refuse to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Haidi Karam</investigator_full_name>
    <investigator_title>Lecturer of Tropical Medicine and Gastroenterology</investigator_title>
  </responsible_party>
  <keyword>Covid-19</keyword>
  <keyword>characteristics</keyword>
  <keyword>Outcome</keyword>
  <keyword>Egypt</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>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/NCT04490772
org study id: COVID gastro intestinal
nct id: NCT04490772
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Patients confirmed COVID-19 with gastrointestinal manifestations will be included.
      Characteristics and outcomes will be described for them.
Patients diagnosed as confirmed Covid-19 according to WHO and Egyptian Ministry of Health and
      Population (MOH) definitions will be included.The following will be done for all patients:

      Demographic characters; age, sex, presence of co-morbidities such as hypretension, diabetes
      mellitus, obstructive lung diseases, ischemic heart diseases...etc, history of contact to
      covid-19 patients or recent travelling abroad.Clinical Characteristics: By recording of
      clinical manifestation such as fever, cough, shortness of breath, sore throat, change in
      taste or smell, nausea,vomiting and diarrhea will be done. Complications and the type of
      treatment received by the patients will also be described including mechanical ventilation.

      Laboratory data will also be included : blood picture, liver enzymes, ESR,CRP, serum
      ferritin, D-dimer and troponin.

      Follow up of the patients will be done until improvement, deaths or complications to
      determine disease outcomes.
observational model: Cohort
time perspective: Prospective
measure: Clinical data questionnaire
time frame: 2 months
description: Clinical characteristics of age, sex, comorbidities and symptoms.
measure: Tests such as CBC
time frame: 2 months
description: Laboratory characters
measure: liver function test
time frame: 2 months
description: Laboratory characters
arm group label: Patients with Covid-19
description: COVID-19 patients presented with gastrointestinal manifestations
intervention type: Diagnostic Test
intervention name: Laboratory tests
description: Laboratory tests such as CBC, Liver function and CRP
arm group label: Patients with Covid-19
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Haidi Karam
investigator title: Lecturer of Tropical Medicine and Gastroenterology
mesh term: COVID-19
sharing ipd: No