Corticosteroid Nasal Spray in COVID-19 Anosmia

Phase 3

Completed

• Conditions: Covid19; Anosmia
• Interventions: Drug: mometasone furoate nasal spray

• Registration Number: NCT04484493
• Lead Sponsor: Benha University

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.

Study Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-23
• Study Start: 2020-08-08
• Primary Completion: 2020-10-25
• Status Verified: 2020-11
• Study Completion: 2020-11-03
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mometasone nasal spray	mometasone furoate 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.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Benha University Hospital, Faculty of Medicine; 🇪🇬 Banhā, Qalubia, Egypt