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临床试验/NCT04569825
NCT04569825Unknown早期 1 期

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

University Of Anbar1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
250
试验地点
1
主要终点
Recovery rate of anosmia and shorten recovery time

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Local Nasal Steroid

Active Comparator

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

干预措施: Ophtamesone (Drug)

Normal Saline

Placebo Comparator

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

干预措施: Ophtamesone (Drug)

结局指标

主要结局

Recovery rate of anosmia and shorten recovery time

时间窗: 30 days

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raid M. Al-Ani

Proffesor

University Of Anbar

研究点 (1)

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