Trial | NCT04569825  Report issue

Official Title

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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    250
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.
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 Started
Aug 01
2020
Primary Completion
Sep 30
2020
Anticipated
Study Completion
Oct 15
2020
Anticipated
Last Update
Sep 30
2020

Drug Ophtamesone

local application intranasally as drops

  • Other names: Normal Saline

Local Nasal Steroid Active Comparator

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

Normal Saline Placebo Comparator

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

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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No Results Posted