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

NCT ID: NCT04569825

Last Updated: 2020-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2020-10-15

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.

Conditions

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Clinical Trial

Keywords

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Anosmia COVID-19 Nasal steroid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Local Nasal Steroid

Application of Local Nasal Steroid for the COVID-19 patients with anosmia

Group Type ACTIVE_COMPARATOR

Ophtamesone

Intervention Type DRUG

local application intranasally as drops

Normal Saline

Application of Normal Saline for the COVID-19 patients with anosmia

Group Type PLACEBO_COMPARATOR

Ophtamesone

Intervention Type DRUG

local application intranasally as drops

Interventions

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Ophtamesone

local application intranasally as drops

Intervention Type DRUG

Other Intervention Names

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Normal Saline

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Of Anbar

OTHER

Sponsor Role lead

Responsible Party

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Raid M. Al-Ani

Proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raid M Al-Ani, FIBMS (ENT)

Role: PRINCIPAL_INVESTIGATOR

University Of Anbar

Locations

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Raid Muhmid Al-Ani

Ramadi, Al Anbar, Iraq

Site Status RECRUITING

Countries

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Iraq

Central Contacts

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Raid M Al-Ani, FIBMS (ENT)

Role: CONTACT

Phone: 07906145364

Email: [email protected]

Facility Contacts

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Raid M Al-Ani, FIBMS (ENT)

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36063364 (View on PubMed)

O'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.

Reference Type DERIVED
PMID: 36062970 (View on PubMed)

Rashid 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.

Reference Type DERIVED
PMID: 33839489 (View on PubMed)

Other Identifiers

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1148

Identifier Type: -

Identifier Source: org_study_id