<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/NCT04487119</url>
  </required_header>
  <id_info>
    <org_study_id>RC 6-7-2020</org_study_id>
    <nct_id>NCT04487119</nct_id>
  </id_info>
  <brief_title>Hematology and Clinical Picture in Pediatric COVID-19 Infection</brief_title>
  <official_title>Pediatric COVID-19 Infection; Do Clinical Features and Hematological Parameters Predict the Need for ICU Admission?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benha University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Benha 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>
      This study is to discuss the different clinical presentations, hematological and laboratory&#xD;
      abnormalities in pediatric COVID-19 infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This retrospective observational study will be conducted at Benha University Hospital, Benha,&#xD;
      Egypt; after approval by the local ethical committee of Faculty of Medicine, Benha&#xD;
      University, Egypt.&#xD;
&#xD;
      We will include in this retrospective study all pediatric patients who were admitted with&#xD;
      confirmed COVID-19 infection with age range from birth to 18 years during the period from&#xD;
      April 2020 till July 2020. The diagnosis of COVID-19 infection is based on positive&#xD;
      SARS-CoV-2 RNA detection in throat swab specimens by PCR.&#xD;
&#xD;
      All data including demography information, contact history, previous history, clinical&#xD;
      symptoms, clinical examination on admission, and hematology and laboratory information will&#xD;
      be obtained from inpatient medical records.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 12, 2020</start_date>
  <completion_date type="Actual">August 23, 2020</completion_date>
  <primary_completion_date type="Actual">August 20, 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>hematological findings</measure>
    <time_frame>at time of admission</time_frame>
    <description>hematological indices; TLC, absolute lymphocytic count, absolute neutrophil count platelet count, N/L ratio and CRP in pediatric COVID-19 infection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical presentations</measure>
    <time_frame>at time of admission</time_frame>
    <description>proportion of patients with respiratory and GIT symptoms, proportion of patients needs ICU admission relation between severity and hematologic indices</description>
  </secondary_outcome>
  <enrollment type="Actual">29</enrollment>
  <condition>Covid19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        all pediatric patients who were admitted with confirmed COVID-19 infection with age range&#xD;
        from birth to 18 years during the period from April 2020 till July 2020. The diagnosis of&#xD;
        COVID-19 infection is based on positive SARS-CoV-2 RNA detection in throat swab specimens&#xD;
        by PCR.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -inpatient confirmed COVID-19 infection by PCR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with records missing hematology and/or laboratory data,&#xD;
&#xD;
          -  patients transfered to other medical facilities with unknown outcomes,&#xD;
&#xD;
          -  patients with age older than 18 years from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shaimaa R Abdelmaksoud, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Benha Faculty of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rana A Khashaba, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Benha Faculty of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Effat H Assar, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Benha Faculty of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rasha S Eldesouky, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Benha Faculty of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Benha Faculty of Medicine</name>
      <address>
        <city>Banhā</city>
        <state>Qalubia</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.</citation>
    <PMID>32031570</PMID>
  </reference>
  <reference>
    <citation>Fan BE, Chong VCL, Chan SSW, Lim GH, Lim KGE, Tan GB, Mucheli SS, Kuperan P, Ong KH. Hematologic parameters in patients with COVID-19 infection. Am J Hematol. 2020 Jun;95(6):E131-E134. doi: 10.1002/ajh.25774. Epub 2020 Mar 19. No abstract available. Erratum In: Am J Hematol. 2020 Nov;95(11):1442.</citation>
    <PMID>32129508</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>September 6, 2020</last_update_submitted>
  <last_update_submitted_qc>September 6, 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>Benha University</investigator_affiliation>
    <investigator_full_name>Shaimaa Reda Abdelmaksoud</investigator_full_name>
    <investigator_title>MD Lecturer pediatrics</investigator_title>
  </responsible_party>
  <keyword>COVID19</keyword>
  <keyword>hematology</keyword>
  <keyword>pediatric</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/NCT04487119
org study id: RC 6-7-2020
nct id: NCT04487119
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is to discuss the different clinical presentations, hematological and laboratory
      abnormalities in pediatric COVID-19 infection.
This retrospective observational study will be conducted at Benha University Hospital, Benha,
      Egypt; after approval by the local ethical committee of Faculty of Medicine, Benha
      University, Egypt.

      We will include in this retrospective study all pediatric patients who were admitted with
      confirmed COVID-19 infection with age range from birth to 18 years during the period from
      April 2020 till July 2020. The diagnosis of COVID-19 infection is based on positive
      SARS-CoV-2 RNA detection in throat swab specimens by PCR.

      All data including demography information, contact history, previous history, clinical
      symptoms, clinical examination on admission, and hematology and laboratory information will
      be obtained from inpatient medical records.
observational model: Cohort
time perspective: Retrospective
measure: hematological findings
time frame: at time of admission
description: hematological indices; TLC, absolute lymphocytic count, absolute neutrophil count platelet count, N/L ratio and CRP in pediatric COVID-19 infection
measure: clinical presentations
time frame: at time of admission
description: proportion of patients with respiratory and GIT symptoms, proportion of patients needs ICU admission relation between severity and hematologic indices
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Shaimaa R Abdelmaksoud, MD
role: Principal Investigator
affiliation: Benha Faculty of Medicine
last name: Rana A Khashaba, MD
role: Study Chair
affiliation: Benha Faculty of Medicine
last name: Effat H Assar, MD
role: Study Chair
affiliation: Benha Faculty of Medicine
last name: Rasha S Eldesouky, MD
role: Study Chair
affiliation: Benha Faculty of Medicine
facility: 
country: Egypt
citation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
PMID: 32031570
citation: Fan BE, Chong VCL, Chan SSW, Lim GH, Lim KGE, Tan GB, Mucheli SS, Kuperan P, Ong KH. Hematologic parameters in patients with COVID-19 infection. Am J Hematol. 2020 Jun;95(6):E131-E134. doi: 10.1002/ajh.25774. Epub 2020 Mar 19. No abstract available. Erratum In: Am J Hematol. 2020 Nov;95(11):1442.
PMID: 32129508
responsible party type: Principal Investigator
investigator affiliation: Benha University
investigator full name: Shaimaa Reda Abdelmaksoud
investigator title: MD Lecturer pediatrics
mesh term: COVID-19
sharing ipd: No