Effect of Nasal Steroid in the Treatment of Anosmia Due to COVID-19 Disease

Study Overview
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Brief Summary
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Background: Anosmia is a debilitating common symptom of COVID-19. The therapeutic effect of systemic steroid for the treatment of anosmia has been studied with various findings of its efficacy. However, the effect of local steroid was not assessed before. Objective: To estimate the efficacy of local steroid in the treatment of anosmia in COVID-19 patients.

Detailed Description
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Background: Anosmia is a debilitating common symptom of COVID-19. The therapeutic effect of systemic steroid for the treatment of anosmia has been studied with various findings of its efficacy. However, the effect of local steroid was not assessed before. Objective: To estimate the efficacy of local steroid in the treatment of anosmia in COVID-19 patients. Materials and Methods: A double-blinded randomized controlled trial was conducted at Al-Ramadi Teaching Hospital and Tikrit Teaching Hospital during the period from 23th August to 30th September. Proven cases by real-time polymerase chain reaction and presented with anosmia alone or with ageusia were enrolled in the study. The patients divided into 4 groups according to the treatment modalities. Group A (local steroid nasal drops), group B (local normal saline nasal drops), group C (systemic and local steroid), and group D (systemic steroid and local normal saline). Comparison between the groups concerning the fate and the recovery time of the anosmia was analyzed. Results and Conclusion: Depends on the finding of the studied patients.

Official Title
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Effect of Nasal Steroid in the Treatment of Anosmia Due to COVID-19 Disease

Conditions
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Clinical Trial

Intervention / Treatment
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* Drug: Ophtamesone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Proven cases of COVID-19 infection by real-time polymerase chain reaction (PCR) of the nasopharyngeal and oropharyngeal swabs and presented with recent onset of anosmia alone or with ageusia or other symptoms of the disease were enrolled in the current study. - Exclusion Criteria: Patients with pregnancy, children <18 year, psychological disturbances, previous anosmia, severe sinonasal diseases, previous sinonasal surgery, refuse to participate in the study, and those who lost to follow-up were excluded from the study. -

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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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Local Nasal Steroid<br>Application of Local Nasal Steroid for the COVID-19 patients with anosmia | Drug: Ophtamesone<br>* local application intranasally as drops<br>* Other names: Normal Saline;|
| Placebo Comparator: Normal Saline<br>Application of Normal Saline for the COVID-19 patients with anosmia | Drug: Ophtamesone<br>* local application intranasally as drops<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery rate of anosmia and shorten recovery time | To estimate the recovery rate for both groups and whether nasal steroid enhance the recovery time | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anosmia, COVID-19, Nasal steroid