Clinical trial NCT04569825: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Clinical Trial
Keywords: Anosmia
COVID-19
Nasal steroid
Lead sponsor: University Of Anbar
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

-

Primary outcomes:
measure: Recovery rate of anosmia and shorten recovery time
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ramadi
country: Iraq
facility: Raid Muhmid Al-Ani
state: Anbar
Study officials:
affiliation: University Of Anbar
name: Raid M Al-Ani, FIBMS (ENT)
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.