Corticosteroid Nasal Spray in COVID-19 Anosmia

Covid19 Clinical Trial

Official title:

Role of Corticosteroid Nasal Spray in Recovery of Smell Sensation in COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04484493
• Other study ID #: RC 4-7-2020
• Status: Completed
• Phase: Phase 3
• Start date: August 8, 2020
• Est. completion date: November 3, 2020

Study information

• Verified date: November 2020
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 3, 2020
• Est. primary completion date: October 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anosmia
• Covid19
• Olfaction Disorders

Intervention

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

Locations

Country	Name	City	State
Egypt	Benha University Hospital, Faculty of Medicine	Banha	Qalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Heilmann S, Just T, Göktas O, Hauswald B, Hüttenbrink 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. German. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   european rhinologic society