Effect of Nasal Steroid in the Treatment of Anosmia Due to COVID-19 Disease
1 other identifier
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2020
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 29, 2020
CompletedFirst Posted
Study publicly available on registry
September 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2020
CompletedSeptember 30, 2020
August 1, 2020
2 months
September 29, 2020
September 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Local Nasal Steroid
ACTIVE COMPARATORApplication of Local Nasal Steroid for the COVID-19 patients with anosmia
Normal Saline
PLACEBO COMPARATORApplication of Normal Saline for the COVID-19 patients with anosmia
Interventions
local application intranasally as drops
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Raid Muhmid Al-Ani
Ramadi, Al-Anbar Governorate, 31001, Iraq
Related Publications (3)
Webster KE, O'Byrne L, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the prevention of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD013877. doi: 10.1002/14651858.CD013877.pub3.
PMID: 36063364DERIVEDO'Byrne L, Webster KE, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the treatment of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD013876. doi: 10.1002/14651858.CD013876.pub3.
PMID: 36062970DERIVEDRashid RA, Zgair A, Al-Ani RM. Effect of nasal corticosteroid in the treatment of anosmia due to COVID-19: A randomised double-blind placebo-controlled study. Am J Otolaryngol. 2021 Sep-Oct;42(5):103033. doi: 10.1016/j.amjoto.2021.103033. Epub 2021 Apr 7.
PMID: 33839489DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raid M Al-Ani, FIBMS (ENT)
University Of Anbar
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Proffesor
Study Record Dates
First Submitted
September 29, 2020
First Posted
September 30, 2020
Study Start
August 1, 2020
Primary Completion
September 30, 2020
Study Completion
October 15, 2020
Last Updated
September 30, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share