<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/NCT04404608</url>
  </required_header>
  <id_info>
    <org_study_id>201920008.2</org_study_id>
    <nct_id>NCT04404608</nct_id>
  </id_info>
  <brief_title>Etiology of Lymphopenia in Covid19 Infection</brief_title>
  <official_title>Study of the Etiology of Lymphopenia in Covid19 Viral Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Medhat Khafagy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Study of the cause of lymphopenia in Covid19 viral infection will be done in 3 cohorts. First&#xD;
      cohort will be patients asymptomatic or with mild symptoms. Second cohort will be patients&#xD;
      with severe illness and admitted to ICU. Third cohort will be patients critically ill and on&#xD;
      artificial ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each cohort will include 30 patients. Complete blood count in all patients will be done daily&#xD;
      in all patients. Bone marrow aspiration cytology will be done in some selected patients&#xD;
      especially those with lymphopenia less than 1000 per cubic mm.&#xD;
&#xD;
      Correlation of the degree of lymphopenia with the status of the patients will be done. Also&#xD;
      correlation will be done about the relation of recovery of lymphopenia and status of the&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Death or recovery</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Follow up</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">172</enrollment>
  <condition>Lymphopenia</condition>
  <arm_group>
    <arm_group_label>Asymptomatic or mild symptoms patients patients</arm_group_label>
    <description>Patients with no or mild symptoms and need no respiratory support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe symptoms patients</arm_group_label>
    <description>Patients who need admission to ICU because he needs oxygen by nasal canula and needs drugs whether azthromycin or remdesivir according to treatment protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Critically ill patients</arm_group_label>
    <description>Patients who need artificial ventilation because of many causes and may need plasma from convalescent patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Complete blood picture, bone marrow aspiration cytology</intervention_name>
    <description>none except the regular routine investigations in such cases</description>
    <arm_group_label>Asymptomatic or mild symptoms patients patients</arm_group_label>
    <arm_group_label>Critically ill patients</arm_group_label>
    <arm_group_label>Severe symptoms patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients admitted with the diagnosis off Covid19 viral infection of all ages and all&#xD;
        ethnic backgrounds and agree about the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient admitted with the diagnosis of Covid19 viral infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient who died within one day of admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>National Cancer Institute Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Dr Medhat Khafagy</investigator_full_name>
    <investigator_title>professor of surgical oncology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphopenia</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/NCT04404608
org study id: 201920008.2
nct id: NCT04404608
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study of the cause of lymphopenia in Covid19 viral infection will be done in 3 cohorts. First
      cohort will be patients asymptomatic or with mild symptoms. Second cohort will be patients
      with severe illness and admitted to ICU. Third cohort will be patients critically ill and on
      artificial ventilation.
Each cohort will include 30 patients. Complete blood count in all patients will be done daily
      in all patients. Bone marrow aspiration cytology will be done in some selected patients
      especially those with lymphopenia less than 1000 per cubic mm.

      Correlation of the degree of lymphopenia with the status of the patients will be done. Also
      correlation will be done about the relation of recovery of lymphopenia and status of the
      patients.
observational model: Cohort
time perspective: Prospective
measure: Death or recovery
time frame: Up to 24 weeks
description: Follow up
arm group label: Asymptomatic or mild symptoms patients patients
description: Patients with no or mild symptoms and need no respiratory support.
arm group label: Severe symptoms patients
description: Patients who need admission to ICU because he needs oxygen by nasal canula and needs drugs whether azthromycin or remdesivir according to treatment protocol.
arm group label: Critically ill patients
description: Patients who need artificial ventilation because of many causes and may need plasma from convalescent patients
intervention type: Diagnostic Test
intervention name: Complete blood picture, bone marrow aspiration cytology
description: none except the regular routine investigations in such cases
arm group label: Asymptomatic or mild symptoms patients patients
arm group label: Critically ill patients
arm group label: Severe symptoms patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Dr Medhat Khafagy
investigator title: professor of surgical oncology
mesh term: Lymphopenia
sharing ipd: No