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

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ClinicalTrials.gov Identifier: NCT04569825
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Raid M. Al-Ani, University Of Anbar

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
Clinical Trial Drug: Ophtamesone 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 1, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 15, 2020

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 Name: 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 Name: Normal Saline




Primary Outcome Measures :
  1. Recovery rate of anosmia and shorten recovery time [ Time Frame: 30 days ]
    To estimate the recovery rate for both groups and whether nasal steroid enhance the recovery time



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04569825


Contacts
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Contact: Raid M Al-Ani, FIBMS (ENT) 07906145364 med.raed.alani2003@uoanbar.edu.iq

Locations
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Iraq
Raid Muhmid Al-Ani Recruiting
Ramadi, Anbar, Iraq, 31001
Contact: Raid M Al-Ani, FIBMS (ENT)    07906145364    med.raed.alani2003@uoanbar.edu.iq   
Sponsors and Collaborators
University Of Anbar
Investigators
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Principal Investigator: Raid M Al-Ani, FIBMS (ENT) University Of Anbar
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Raid M. Al-Ani, Proffesor, University Of Anbar
ClinicalTrials.gov Identifier: NCT04569825    
Other Study ID Numbers: 1148
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University Of Anbar:
Anosmia
COVID-19
Nasal steroid
Additional relevant MeSH terms:
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COVID-19
Anosmia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Olfaction Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases