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

Clinical Trial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04569825
• Other study ID #: 1148
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 1, 2020
• Est. completion date: October 15, 2020

Study information

• Verified date: August 2020
• Source: University Of Anbar
• Contact: Raid M Al-Ani, FIBMS (ENT)
• Phone: 07906145364
• Email: med.raed.alani2003[@]uoanbar.edu.iq
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 15, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Clinical Trial
• Olfaction Disorders

Intervention

Drug:
• Ophtamesone
local application intranasally as drops

Locations

Country	Name	City	State
Iraq	Raid Muhmid Al-Ani	Ramadi	Anbar

Sponsors (1)

Lead Sponsor	Collaborator
University Of Anbar

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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