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

University Of Anbar

Status and phase: Unknown; Early Phase 1

Conditions: Clinical Trial

Treatments: Drug: Ophtamesone

Study type: Interventional

Funder types: Other

Identifiers

NCT04569825

1148

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups, including a placebo group

Local Nasal Steroid

Active Comparator group

Description:

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

Treatment:

Drug: Ophtamesone

Normal Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Ophtamesone