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

Early Phase 1
Conditions
Clinical Trial
Interventions
Drug: Ophtamesone
Registration Number
NCT04569825
Lead Sponsor
University Of Anbar
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
250
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.

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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.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Local Nasal SteroidOphtamesoneApplication of Local Nasal Steroid for the COVID-19 patients with anosmia
Normal SalineOphtamesoneApplication of Normal Saline for the COVID-19 patients with anosmia
Primary Outcome Measures
NameTimeMethod
Recovery rate of anosmia and shorten recovery time30 days

To estimate the recovery rate for both groups and whether nasal steroid enhance the recovery time

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Raid Muhmid Al-Ani

🇮🇶

Ramadi, Anbar, Iraq

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