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

Primary Purpose

Clinical Trial

Status
Unknown status
Phase
Early Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
Ophtamesone
Sponsored by
University Of Anbar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical Trial focused on measuring Anosmia, COVID-19, Nasal steroid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

-

Sites / Locations

  • Raid Muhmid Al-AniRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Local Nasal Steroid

Normal Saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recovery rate of anosmia and shorten recovery time
To estimate the recovery rate for both groups and whether nasal steroid enhance the recovery time

Secondary Outcome Measures

Full Information

First Posted
September 29, 2020
Last Updated
September 29, 2020
Sponsor
University Of Anbar
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1. Study Identification

Unique Protocol Identification Number
NCT04569825
Brief Title
Effect of Nasal Steroid in the Treatment of Anosmia Due to COVID-19 Disease
Official Title
Effect of Nasal Steroid in the Treatment of Anosmia Due to COVID-19 Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
October 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Of Anbar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Trial
Keywords
Anosmia, COVID-19, Nasal steroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Local Nasal Steroid
Arm Type
Active Comparator
Arm Description
Application of Local Nasal Steroid for the COVID-19 patients with anosmia
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Application of Normal Saline for the COVID-19 patients with anosmia
Intervention Type
Drug
Intervention Name(s)
Ophtamesone
Other Intervention Name(s)
Normal Saline
Intervention Description
local application intranasally as drops
Primary Outcome Measure Information:
Title
Recovery rate of anosmia and shorten recovery time
Description
To estimate the recovery rate for both groups and whether nasal steroid enhance the recovery time
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raid M Al-Ani, FIBMS (ENT)
Phone
07906145364
Email
med.raed.alani2003@uoanbar.edu.iq
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raid M Al-Ani, FIBMS (ENT)
Organizational Affiliation
University Of Anbar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raid Muhmid Al-Ani
City
Ramadi
State/Province
Anbar
ZIP/Postal Code
31001
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raid M Al-Ani, FIBMS (ENT)
Phone
07906145364
Email
med.raed.alani2003@uoanbar.edu.iq

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36063364
Citation
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.
Results Reference
derived
PubMed Identifier
36062970
Citation
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.
Results Reference
derived
PubMed Identifier
33839489
Citation
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.
Results Reference
derived

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

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