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CompletedNCT04484493Updated Nov 13, 2020

Corticosteroid Nasal Spray in COVID-19 Anosmia

A Phase 3 interventional study of mometasone furoate nasal spray in Covid19 and Anosmia, sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by Benha University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Covid19
  • Anosmia

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Keywords

  • covid19
  • anosmia
  • mometasone nasal spray
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • 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

  • No intervention
    control

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

Interventions

  • Drugmometasone furoate nasal spray

    dose of 2 puff in each nostril (100 µg once daily each nostril).

    Also known as: steroid nasal spray

06

What researchers measure

Primary outcomes

  1. improvement of olfaction

    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).

    Time frame: 3 weeks

07

Study locations

1 site
  • Benha University Hospital, Faculty of Medicine
    Banhā, Qalubia 13512, Egypt
08

References and documents

Publications

  • 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. PubMed 15538662 ↗
  • 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. PubMed 32567798 ↗
  • Webster KE, O'Byrne L, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the prevention of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD013877. doi: 10.1002/14651858.CD013877.pub3. PubMed 36063364 ↗
  • Abdelalim AA, Mohamady AA, Elsayed RA, Elawady MA, Ghallab AF. Corticosteroid nasal spray for recovery of smell sensation in COVID-19 patients: A randomized controlled trial. Am J Otolaryngol. 2021 Mar-Apr;42(2):102884. doi: 10.1016/j.amjoto.2020.102884. Epub 2021 Jan 4. PubMed 33429174 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04484493
Lead sponsor
Benha University
Responsible party
Abdelrahman Ahmed Abdelalim (MD lecturer, Benha University) — Principal investigator
First posted
Jul 23, 2020
Start date
Aug 8, 2020
Primary completion
Oct 25, 2020
Completion
Nov 3, 2020
Last update
Nov 13, 2020

Study contacts

Abdelrahman A Abdelalim, MD
principal investigator · Benha Faculty of Medicine
Rasha A Elsayed, MD
study chair · Benha Faculty of Medicine
Mona A Elawady, MD
study chair · Benha Faculty of Medicine
Abdelhakim F Ghallab, MD
study chair · Benha Faculty of Medicine
Ayman A Mohamady, MD
study chair · Benha Faculty of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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