NCT04484493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at below P25 for phase_3 covid19

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

August 8, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

July 22, 2020

Last Update Submit

November 11, 2020

Conditions

Covid19Anosmia

Keywords

covid19anosmiamometasone nasal spray

Outcome Measures

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).

    3 weeks

Study Arms (2)

mometasone nasal spray

EXPERIMENTAL

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

control

NO INTERVENTION

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

Interventions

mometasone furoate nasal sprayDRUG

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

Also known as: steroid nasal spray
mometasone nasal spray

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults 18 yrs or older patients
  • confirmed case (+ve PCR),
  • recovered/discharged (2 -ve PCR),
  • suffered from sudden recent anosmia or hyposmia

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University Hospital, Faculty of Medicine

Banhā, Qalyubia Governorate, 13512, Egypt

Location

Related Publications (4)

  • 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: 15538662BACKGROUND

  • 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: 32567798BACKGROUND

  • 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.

    PMID: 36063364DERIVED

  • 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.

    PMID: 33429174DERIVED

MeSH Terms

Conditions

COVID-19Anosmia

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesOlfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Abdelrahman A Abdelalim, MD

    Benha University

    PRINCIPAL INVESTIGATOR

  • Rasha A Elsayed, MD

    Benha University

    STUDY CHAIR

  • Mona A Elawady, MD

    Benha University

    STUDY CHAIR

  • Abdelhakim F Ghallab, MD

    Benha University

    STUDY CHAIR

  • Ayman A Mohamady, MD

    Benha University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD lecturer

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 23, 2020

Study Start

August 8, 2020

Primary Completion

October 25, 2020

Study Completion

November 3, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)