<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/NCT04484493</url>
  </required_header>
  <id_info>
    <org_study_id>RC 4-7-2020</org_study_id>
    <nct_id>NCT04484493</nct_id>
  </id_info>
  <brief_title>Corticosteroid Nasal Spray in COVID-19 Anosmia</brief_title>
  <official_title>Role of Corticosteroid Nasal Spray in Recovery of Smell Sensation in COVID-19 Patients</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>
      The aim of this study is to evaluate the role of the topical corticosteroids nasal spray&#xD;
      (mometasone furoate nasal spray) in improving anosmia in patients recovered from COVID-19&#xD;
      infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study willbe submitted on patients who recently recovered from proven COVID-19 infection&#xD;
      and complaining of anosmia or hyposmia.The proven COVID-19 infection will be relied on a&#xD;
      positive real-time reverse transcription polymerase chain reaction (rRT-PCR) with samples&#xD;
      obtained by a nasopharyngeal swab. The recovery is defined as 2 consecutives negative&#xD;
      (rRT-PCR) samples.&#xD;
&#xD;
      Complete medical history will be taken, and essential clinical assessment with appropriate&#xD;
      protective measures will be performed in all patients.The patients in the study will be&#xD;
      randomly divided into two groups: - Group I: -who will receive topical corticosteroid nasal&#xD;
      spray (mometasone furoate nasal spray) beside olfactory training Group II: -who will not&#xD;
      receive topical corticosteroid nasal spray but only olfactory training.&#xD;
&#xD;
      As regards the assessment of smell,the patient will assess his smell sensation using familiar&#xD;
      substances with distinctive odor. A jar of coffee, a branch of mint and garlic are some used&#xD;
      substances. The patient will report the degree of anosmia subjectively with score on a scale&#xD;
      from 0 to 10.The assessment of smell will be done initially after recovery/discharge, after 1&#xD;
      week, 2 weeks and after 3 weeks for all patients. The duration of smell loss will be recorded&#xD;
      from the onset of anosmia till full recovery of the sensation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2020</start_date>
  <completion_date type="Actual">November 3, 2020</completion_date>
  <primary_completion_date type="Actual">October 25, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>improvement of olfaction</measure>
    <time_frame>3 weeks</time_frame>
    <description>The patient will report the degree of anosmia subjectively with score on a scale from 0 to 10 (0 means total loss of smell and 10 refers to completely normal smell sensation).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Covid19</condition>
  <condition>Anosmia</condition>
  <arm_group>
    <arm_group_label>mometasone nasal spray</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive topical corticosteroid nasal spray (mometasone furoate nasal spray) in appropriate dose of 2 puff in each nostril (100 µg once daily) beside olfactory training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will not receive topical corticosteroid nasal spray but only olfactory training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mometasone furoate nasal spray</intervention_name>
    <description>dose of 2 puff in each nostril (100 µg once daily each nostril).</description>
    <arm_group_label>mometasone nasal spray</arm_group_label>
    <other_name>steroid nasal spray</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults 18 yrs or older patients&#xD;
&#xD;
          -  confirmed case (+ve PCR),&#xD;
&#xD;
          -  recovered/discharged (2 -ve PCR),&#xD;
&#xD;
          -  suffered from sudden recent anosmia or hyposmia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients already on nasal steroid&#xD;
&#xD;
          -  with previous chronic rhinological pathologies,&#xD;
&#xD;
          -  patients on systemic steroid for previous systemic disease,&#xD;
&#xD;
          -  anosmia improved before COVID19 recovery,&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  patients who will not complete the follow up period.&#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>Abdelrahman A Abdelalim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Benha Faculty of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rasha A Elsayed, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Benha Faculty of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mona A Elawady, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Benha Faculty of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Abdelhakim F Ghallab, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Benha Faculty of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ayman A Mohamady, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Benha Faculty of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Benha University Hospital, Faculty of Medicine</name>
      <address>
        <city>Banhā</city>
        <state>Qalubia</state>
        <zip>13512</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Heilmann S, Just T, Goktas O, Hauswald B, Huttenbrink KB, Hummel T. [Effects of systemic or topical administration of corticosteroids and vitamin B in patients with olfactory loss]. Laryngorhinootologie. 2004 Nov;83(11):729-34. doi: 10.1055/s-2004-825676. German.</citation>
    <PMID>15538662</PMID>
  </reference>
  <reference>
    <citation>Hura N, Xie DX, Choby GW, Schlosser RJ, Orlov CP, Seal SM, Rowan NR. Treatment of post-viral olfactory dysfunction: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2020 Sep;10(9):1065-1086. doi: 10.1002/alr.22624. Epub 2020 Jun 25.</citation>
    <PMID>32567798</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>November 11, 2020</last_update_submitted>
  <last_update_submitted_qc>November 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Benha University</investigator_affiliation>
    <investigator_full_name>Abdelrahman Ahmed Abdelalim</investigator_full_name>
    <investigator_title>MD lecturer</investigator_title>
  </responsible_party>
  <keyword>covid19</keyword>
  <keyword>anosmia</keyword>
  <keyword>mometasone nasal spray</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mometasone Furoate</mesh_term>
  </intervention_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/NCT04484493
org study id: RC 4-7-2020
nct id: NCT04484493
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the role of the topical corticosteroids nasal spray
      (mometasone furoate nasal spray) in improving anosmia in patients recovered from COVID-19
      infection.
This study willbe submitted on patients who recently recovered from proven COVID-19 infection
      and complaining of anosmia or hyposmia.The proven COVID-19 infection will be relied on a
      positive real-time reverse transcription polymerase chain reaction (rRT-PCR) with samples
      obtained by a nasopharyngeal swab. The recovery is defined as 2 consecutives negative
      (rRT-PCR) samples.

      Complete medical history will be taken, and essential clinical assessment with appropriate
      protective measures will be performed in all patients.The patients in the study will be
      randomly divided into two groups: - Group I: -who will receive topical corticosteroid nasal
      spray (mometasone furoate nasal spray) beside olfactory training Group II: -who will not
      receive topical corticosteroid nasal spray but only olfactory training.

      As regards the assessment of smell,the patient will assess his smell sensation using familiar
      substances with distinctive odor. A jar of coffee, a branch of mint and garlic are some used
      substances. The patient will report the degree of anosmia subjectively with score on a scale
      from 0 to 10.The assessment of smell will be done initially after recovery/discharge, after 1
      week, 2 weeks and after 3 weeks for all patients. The duration of smell loss will be recorded
      from the onset of anosmia till full recovery of the sensation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: improvement of olfaction
time frame: 3 weeks
description: The patient will report the degree of anosmia subjectively with score on a scale from 0 to 10 (0 means total loss of smell and 10 refers to completely normal smell sensation).
arm group label: mometasone nasal spray
arm group type: Experimental
description: Patients will receive topical corticosteroid nasal spray (mometasone furoate nasal spray) in appropriate dose of 2 puff in each nostril (100 µg once daily) beside olfactory training.
arm group label: control
arm group type: No Intervention
description: Patients will not receive topical corticosteroid nasal spray but only olfactory training.
intervention type: Drug
intervention name: mometasone furoate nasal spray
description: dose of 2 puff in each nostril (100 µg once daily each nostril).
arm group label: mometasone nasal spray
other name: steroid nasal spray
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Abdelrahman A Abdelalim, MD
role: Principal Investigator
affiliation: Benha Faculty of Medicine
last name: Rasha A Elsayed, MD
role: Study Chair
affiliation: Benha Faculty of Medicine
last name: Mona A Elawady, MD
role: Study Chair
affiliation: Benha Faculty of Medicine
last name: Abdelhakim F Ghallab, MD
role: Study Chair
affiliation: Benha Faculty of Medicine
last name: Ayman A Mohamady, MD
role: Study Chair
affiliation: Benha Faculty of Medicine
facility: 
country: Egypt
citation: Heilmann S, Just T, Goktas O, Hauswald B, Huttenbrink KB, Hummel T. [Effects of systemic or topical administration of corticosteroids and vitamin B in patients with olfactory loss]. Laryngorhinootologie. 2004 Nov;83(11):729-34. doi: 10.1055/s-2004-825676. German.
PMID: 15538662
citation: Hura N, Xie DX, Choby GW, Schlosser RJ, Orlov CP, Seal SM, Rowan NR. Treatment of post-viral olfactory dysfunction: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2020 Sep;10(9):1065-1086. doi: 10.1002/alr.22624. Epub 2020 Jun 25.
PMID: 32567798
responsible party type: Principal Investigator
investigator affiliation: Benha University
investigator full name: Abdelrahman Ahmed Abdelalim
investigator title: MD lecturer
mesh term: COVID-19
mesh term: Anosmia
mesh term: Mometasone Furoate
sharing ipd: No