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Corticosteroid Nasal Spray in COVID-19 Anosmia

Sponsor
Benha University (Other)
Overall Status
Completed
CT.gov ID
NCT04484493
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
2.9
Actual Duration (Months)
35
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: mometasone furoate nasal spray
 Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Role of Corticosteroid Nasal Spray in Recovery of Smell Sensation in COVID-19 Patients
Actual Study Start Date :
Aug 8, 2020
Actual Primary Completion Date :
Oct 25, 2020
Actual Study Completion Date :
Nov 3, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: mometasone nasal spray

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.

Drug: mometasone furoate nasal spray
dose of 2 puff in each nostril (100 µg once daily each nostril).
Other Names:
  • steroid nasal spray

    		•
    No Intervention: control

    Patients will not receive topical corticosteroid nasal spray but only olfactory training.

    Outcome Measures

    Primary Outcome Measures

    1. improvement of olfaction [3 weeks]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • adults 18 yrs or older patients

    • confirmed case (+ve PCR),

    • recovered/discharged (2 -ve PCR),

    • suffered from sudden recent anosmia or hyposmia

    Exclusion Criteria:

    • patients already on nasal steroid

    • with previous chronic rhinological pathologies,

    • patients on systemic steroid for previous systemic disease,

    • anosmia improved before COVID19 recovery,

    • pregnancy

    • patients who will not complete the follow up period.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Benha University Hospital, Faculty of Medicine Banhā Qalubia Egypt 13512

    Sponsors and Collaborators

    • Benha University

    Investigators

    • Principal Investigator: Abdelrahman A Abdelalim, MD, Benha Faculty of Medicine
    • Study Chair: Rasha A Elsayed, MD, Benha Faculty of Medicine
    • Study Chair: Mona A Elawady, MD, Benha Faculty of Medicine
    • Study Chair: Abdelhakim F Ghallab, MD, Benha Faculty of Medicine
    • Study Chair: Ayman A Mohamady, MD, Benha Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Abdelrahman Ahmed Abdelalim, MD lecturer, Benha University
    ClinicalTrials.gov Identifier:
    NCT04484493
    Other Study ID Numbers:
    • RC 4-7-2020
    First Posted:
    Jul 23, 2020
    Last Update Posted:
    Nov 13, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Abdelrahman Ahmed Abdelalim, MD lecturer, Benha University
    covid19
    anosmia
    mometasone nasal spray
    Additional relevant MeSH terms:
    COVID-19
    Anosmia
    Mometasone Furoate

    Study Results

    No Results Posted as of Nov 13, 2020