Clinical trial NCT04484493: Corticosteroid Nasal Spray in COVID-19 Anosmia
Official title: Role of Corticosteroid Nasal Spray in Recovery of Smell Sensation in COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Anosmia
Keywords: covid19
anosmia
mometasone nasal spray
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: improvement of olfaction
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University Hospital, Faculty of Medicine
state: Qalubia
Study officials:
affiliation: Benha University
name: Abdelrahman A Abdelalim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Benha University
name: Rasha A Elsayed, MD
role: STUDY_CHAIR
affiliation: Benha University
name: Mona A Elawady, MD
role: STUDY_CHAIR
affiliation: Benha University
name: Abdelhakim F Ghallab, MD
role: STUDY_CHAIR
affiliation: Benha University
name: Ayman A Mohamady, MD
role: STUDY_CHAIR
References:
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: 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: 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.
citation: 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.