Corticosteroid Nasal Spray in COVID-19 Anosmia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19, Anosmia

Intervention / Treatment
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* Drug: mometasone furoate nasal spray


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mometasone nasal spray<br>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<br>* dose of 2 puff in each nostril (100 µg once daily each nostril).<br>* Other names: steroid nasal spray;|
| No Intervention: control<br>Patients will not receive topical corticosteroid nasal spray but only olfactory training. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid19, anosmia, mometasone nasal spray