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

Sponsor
University Of Anbar (Other)
Overall Status
Unknown status
CT.gov ID
NCT04569825
Collaborator
(none)
250
Enrollment
1
Location
2
Arms
2.5
Anticipated Duration (Months)
101.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Nasal Steroid in the Treatment of Anosmia Due to COVID-19 Disease
Actual Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Sep 30, 2020
Anticipated Study Completion Date :
Oct 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Local Nasal Steroid

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

Drug: Ophtamesone
local application intranasally as drops
Other Names:
  • Normal Saline

    		•
    Placebo Comparator: Normal Saline

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

    Drug: Ophtamesone
    local application intranasally as drops
    Other Names:
  • Normal Saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Recovery rate of anosmia and shorten recovery time [30 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Raid Muhmid Al-Ani Ramadi Anbar Iraq 31001

    Sponsors and Collaborators

    • University Of Anbar

    Investigators

    • Principal Investigator: Raid M Al-Ani, FIBMS (ENT), University Of Anbar

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Raid M. Al-Ani, Proffesor, University Of Anbar
    ClinicalTrials.gov Identifier:
    NCT04569825
    Other Study ID Numbers:
    • 1148
    First Posted:
    Sep 30, 2020
    Last Update Posted:
    Sep 30, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Raid M. Al-Ani, Proffesor, University Of Anbar
    Anosmia
    COVID-19
    Nasal steroid
    Additional relevant MeSH terms:
    COVID-19
    Anosmia

    Study Results

    No Results Posted as of Sep 30, 2020