<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/NCT04445610</url>
  </required_header>
  <id_info>
    <org_study_id>FMASU P31a/ 2020</org_study_id>
    <nct_id>NCT04445610</nct_id>
  </id_info>
  <brief_title>Measles Vaccine: Is There a Protective Role in COVID 19 Pandemic?</brief_title>
  <official_title>Measles Vaccine: Is There a Protective Role in COVID 19 Pandemic?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      The following two mechanisms that explain the ability of measles vaccine to cause partial&#xD;
      protection against COVID-19. The first is that measles vaccine may increase the ability of&#xD;
      the immune system to fight off pathogens other than measles due to the generated bystander&#xD;
      immunity that would enhance the overall immunity against the new coronavirus. The second is&#xD;
      that SARS-CoV-2 is proven to have structure similarities with measles, which may cause&#xD;
      cross-reactivity and immunity between measles vaccines and COVID-19, leading to partial&#xD;
      protection against COVID-19 in vaccinated subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives:&#xD;
&#xD;
        1. To identify Measles IgG titre in SARS-COV2 infected patients .&#xD;
&#xD;
        2. correlate level of Measles IgG titre with the clinical severity of COVID-19 disease.&#xD;
&#xD;
      Secondary Objective To find an association of the postulated protective role of measles&#xD;
      vaccine and SARS-COV2 infection&#xD;
&#xD;
      Criteria:&#xD;
&#xD;
      Inclusion criteria:included patients would be divided into 3 groups according to clinical&#xD;
      severity of COVID-19 disease (mild ,moderate &amp; severe)&#xD;
&#xD;
        -  All patients with confirmed COVID 19 confirmed by positive PCR . .&#xD;
&#xD;
        -  Any age or gender.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
      - Any patient refusing to be involved in the study.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
        -  Informed consent will be taken from each subject&#xD;
&#xD;
        -  Full clinical examination.&#xD;
&#xD;
        -  Evaluation of Measles Antibody Titer:&#xD;
&#xD;
      The measles virus IgG antibody titer will be determined quantitatively by ELISA for&#xD;
      quantitative determination of IgG class antibodies against Measles virus in human serum or&#xD;
      plasma (citrate, heparin).&#xD;
&#xD;
      - Anonymous data will be retrieved from the admitted patients' files, such as:&#xD;
&#xD;
        -  CBC, CRP, AST, ALT, ESR, Serum ferritin &amp; SARS CoV 2 RNA PCR swab results.&#xD;
&#xD;
        -  Chest X ray and/or CT chest.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">November 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Viral clearance</measure>
    <time_frame>6 months</time_frame>
    <description>Achievement of two consecutive negative PCR results for COVID 19 and discharge from hospital</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Coronavirus (COVID-19)</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <description>mild</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <description>moderate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C</arm_group_label>
    <description>severe</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        all patients with confirmed COVID-19 presented to Ain Shams Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with confirmed COVID 19.&#xD;
&#xD;
          -  Any age or gender&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Any patient refusing to be involved in the study&#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>Amira Al Balakosy, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amira Al Balakosy, MD</last_name>
    <phone>01221977455</phone>
    <email>drbalakosy@gmail.com</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>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Amira Al Balakosy</investigator_full_name>
    <investigator_title>Tropical Medicine Department. Ain Shams University</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/NCT04445610
org study id: FMASU P31a/ 2020
nct id: NCT04445610
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The following two mechanisms that explain the ability of measles vaccine to cause partial
      protection against COVID-19. The first is that measles vaccine may increase the ability of
      the immune system to fight off pathogens other than measles due to the generated bystander
      immunity that would enhance the overall immunity against the new coronavirus. The second is
      that SARS-CoV-2 is proven to have structure similarities with measles, which may cause
      cross-reactivity and immunity between measles vaccines and COVID-19, leading to partial
      protection against COVID-19 in vaccinated subjects
Objectives:

        1. To identify Measles IgG titre in SARS-COV2 infected patients .

        2. correlate level of Measles IgG titre with the clinical severity of COVID-19 disease.

      Secondary Objective To find an association of the postulated protective role of measles
      vaccine and SARS-COV2 infection

      Criteria:

      Inclusion criteria:included patients would be divided into 3 groups according to clinical
      severity of COVID-19 disease (mild ,moderate & severe)

        -  All patients with confirmed COVID 19 confirmed by positive PCR . .

        -  Any age or gender.

      Exclusion criteria:

      - Any patient refusing to be involved in the study.

      Methods:

        -  Informed consent will be taken from each subject

        -  Full clinical examination.

        -  Evaluation of Measles Antibody Titer:

      The measles virus IgG antibody titer will be determined quantitatively by ELISA for
      quantitative determination of IgG class antibodies against Measles virus in human serum or
      plasma (citrate, heparin).

      - Anonymous data will be retrieved from the admitted patients' files, such as:

        -  CBC, CRP, AST, ALT, ESR, Serum ferritin & SARS CoV 2 RNA PCR swab results.

        -  Chest X ray and/or CT chest.
observational model: Case-Only
time perspective: Prospective
measure: Viral clearance
time frame: 6 months
description: Achievement of two consecutive negative PCR results for COVID 19 and discharge from hospital
arm group label: A
description: mild
arm group label: B
description: moderate
arm group label: C
description: severe
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Amira Al Balakosy, M.D
role: Principal Investigator
affiliation: Ain Shams University
last name: Amira Al Balakosy, MD
phone: 01221977455
email: drbalakosy@gmail.com
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Amira Al Balakosy
investigator title: Tropical Medicine Department. Ain Shams University
mesh term: COVID-19
sharing ipd: No