<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/NCT04473157</url>
  </required_header>
  <id_info>
    <org_study_id>FMASU P45a/2020</org_study_id>
    <nct_id>NCT04473157</nct_id>
  </id_info>
  <brief_title>COVID-19 in Patients With Anosmia in Egypt</brief_title>
  <official_title>Detection of SARS-CoV-2 in Patients Presenting With Anosmia During COVID-19 Pandemic Era in Egypt</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>
    <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>
      The study aims to test the frequency of severe acute respiratory syndrome new corona virus&#xD;
      SARS-CoV-2 or other respiratory viruses in patients presenting with anosmia or dysgeusia to&#xD;
      Ain Shams University Hospitals, Cairo, Egypt.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fifty Patients presenting to Triage and/or Ear, Nose and Throat (ENT) clinics in Ain Shams&#xD;
      University Hospitals with the chief complaint of Anosmia/ dysgeusia in the period July-&#xD;
      September 2020; will undergo thorough history taking, clinical assessment and polymers chain&#xD;
      reaction rt-PCR to SARS-COV2; and if proven negative to COVID 19, PCR to other respiratory&#xD;
      pathogens will be tested. COVID-19 patients will be managed according to the standard&#xD;
      protocol of Ain Shams University Hospitals. Follow up after 3 weeks for the outcome of&#xD;
      recovery of the smell sense and seroconversion by rapid test for immunoglobulins IgM/ IgG of&#xD;
      COVID 19, for the probability of a false negative PCR at initial visit.&#xD;
&#xD;
      Ethical committee approval for the current study protocol was obtained. Patients will be&#xD;
      invited to participate and the informed consent will be signed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 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>Recovery from Anosmia</measure>
    <time_frame>3 weeks</time_frame>
    <description>subjective questionnaire about smell and taste</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroconversion</measure>
    <time_frame>3 weeks</time_frame>
    <description>developing IgM/ IgG antibodies by rapid test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>COVID 19</measure>
    <time_frame>3 weeks</time_frame>
    <description>developing other symptoms of COVID 19</description>
  </secondary_outcome>
  <enrollment type="Actual">58</enrollment>
  <condition>Anosmia</condition>
  <condition>Covid19</condition>
  <condition>Dysgeusia</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Nasopharyngeal and oropharyngeal Swabs&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Fifty Patients presenting to Triage and/or ENT clinics in Ain Shams University Hospitals&#xD;
        with the chief complaint of Anosmia/ dysgeusia in the period July- August 2020&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult (&gt;18 years) patients presented with acute-onset anosmia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with anosmia or gustatory dysfunctions before the epidemic; patients with&#xD;
             previous history of chronic sinusitis or previous sinus surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ossama I Mansour, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ain Shams University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html</url>
    <description>Symptoms of coronavirus. US Centers for Disease Control and Prevention website.</description>
  </link>
  <reference>
    <citation>Moein ST, Hashemian SM, Mansourafshar B, Khorram-Tousi A, Tabarsi P, Doty RL. Smell dysfunction: a biomarker for COVID-19. Int Forum Allergy Rhinol. 2020 Aug;10(8):944-950. doi: 10.1002/alr.22587. Epub 2020 Jun 18.</citation>
    <PMID>32301284</PMID>
  </reference>
  <reference>
    <citation>Spinato G, Fabbris C, Polesel J, Cazzador D, Borsetto D, Hopkins C, Boscolo-Rizzo P. Alterations in Smell or Taste in Mildly Symptomatic Outpatients With SARS-CoV-2 Infection. JAMA. 2020 May 26;323(20):2089-2090. doi: 10.1001/jama.2020.6771.</citation>
    <PMID>32320008</PMID>
  </reference>
  <reference>
    <citation>Menni C, Valdes AM, Freidin MB, Sudre CH, Nguyen LH, Drew DA, Ganesh S, Varsavsky T, Cardoso MJ, El-Sayed Moustafa JS, Visconti A, Hysi P, Bowyer RCE, Mangino M, Falchi M, Wolf J, Ourselin S, Chan AT, Steves CJ, Spector TD. Real-time tracking of self-reported symptoms to predict potential COVID-19. Nat Med. 2020 Jul;26(7):1037-1040. doi: 10.1038/s41591-020-0916-2. Epub 2020 May 11.</citation>
    <PMID>32393804</PMID>
  </reference>
  <reference>
    <citation>Desforges M, Le Coupanec A, Brison E, Meessen-Pinard M, Talbot PJ. Neuroinvasive and neurotropic human respiratory coronaviruses: potential neurovirulent agents in humans. Adv Exp Med Biol. 2014;807:75-96. doi: 10.1007/978-81-322-1777-0_6.</citation>
    <PMID>24619619</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>January 14, 2021</last_update_submitted>
  <last_update_submitted_qc>January 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ossama Mansour, MD, FACS</investigator_full_name>
    <investigator_title>Professor of Otolaryngology</investigator_title>
  </responsible_party>
  <keyword>Corona virus</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Olfactory Disturbance</keyword>
  <keyword>Taste Disturbance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Anosmia</mesh_term>
    <mesh_term>Dysgeusia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04473157
org study id: FMASU P45a/2020
nct id: NCT04473157
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to test the frequency of severe acute respiratory syndrome new corona virus
      SARS-CoV-2 or other respiratory viruses in patients presenting with anosmia or dysgeusia to
      Ain Shams University Hospitals, Cairo, Egypt.
Fifty Patients presenting to Triage and/or Ear, Nose and Throat (ENT) clinics in Ain Shams
      University Hospitals with the chief complaint of Anosmia/ dysgeusia in the period July-
      September 2020; will undergo thorough history taking, clinical assessment and polymers chain
      reaction rt-PCR to SARS-COV2; and if proven negative to COVID 19, PCR to other respiratory
      pathogens will be tested. COVID-19 patients will be managed according to the standard
      protocol of Ain Shams University Hospitals. Follow up after 3 weeks for the outcome of
      recovery of the smell sense and seroconversion by rapid test for immunoglobulins IgM/ IgG of
      COVID 19, for the probability of a false negative PCR at initial visit.

      Ethical committee approval for the current study protocol was obtained. Patients will be
      invited to participate and the informed consent will be signed.
observational model: Case-Only
time perspective: Prospective
measure: Recovery from Anosmia
time frame: 3 weeks
description: subjective questionnaire about smell and taste
measure: Seroconversion
time frame: 3 weeks
description: developing IgM/ IgG antibodies by rapid test
measure: COVID 19
time frame: 3 weeks
description: developing other symptoms of COVID 19
Nasopharyngeal and oropharyngeal Swabs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ossama I Mansour, MD
role: Principal Investigator
affiliation: Ain Shams University
facility: 
country: Egypt
url: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
description: Symptoms of coronavirus. US Centers for Disease Control and Prevention website.
citation: Moein ST, Hashemian SM, Mansourafshar B, Khorram-Tousi A, Tabarsi P, Doty RL. Smell dysfunction: a biomarker for COVID-19. Int Forum Allergy Rhinol. 2020 Aug;10(8):944-950. doi: 10.1002/alr.22587. Epub 2020 Jun 18.
PMID: 32301284
citation: Spinato G, Fabbris C, Polesel J, Cazzador D, Borsetto D, Hopkins C, Boscolo-Rizzo P. Alterations in Smell or Taste in Mildly Symptomatic Outpatients With SARS-CoV-2 Infection. JAMA. 2020 May 26;323(20):2089-2090. doi: 10.1001/jama.2020.6771.
PMID: 32320008
citation: Menni C, Valdes AM, Freidin MB, Sudre CH, Nguyen LH, Drew DA, Ganesh S, Varsavsky T, Cardoso MJ, El-Sayed Moustafa JS, Visconti A, Hysi P, Bowyer RCE, Mangino M, Falchi M, Wolf J, Ourselin S, Chan AT, Steves CJ, Spector TD. Real-time tracking of self-reported symptoms to predict potential COVID-19. Nat Med. 2020 Jul;26(7):1037-1040. doi: 10.1038/s41591-020-0916-2. Epub 2020 May 11.
PMID: 32393804
citation: Desforges M, Le Coupanec A, Brison E, Meessen-Pinard M, Talbot PJ. Neuroinvasive and neurotropic human respiratory coronaviruses: potential neurovirulent agents in humans. Adv Exp Med Biol. 2014;807:75-96. doi: 10.1007/978-81-322-1777-0_6.
PMID: 24619619
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ossama Mansour, MD, FACS
investigator title: Professor of Otolaryngology
mesh term: COVID-19
mesh term: Anosmia
mesh term: Dysgeusia