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临床试验/NCT05269030
NCT05269030Unknown2 期

The Potential Therapeutic Effect of Ivermectin Nasal Drops in the Treatment of Post COVID-19 Parosmia

Menoufia University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
60
试验地点
1
主要终点
Comparison between the pre and post treatment values

研究概览

简要总结

The current study will be a pilot study for a randomized controlled trial conducted on patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine To evaluate the effect of ivermectin nasal drops in the treatment of post COVID 19 parosmia

详细描述

The current study will be a pilot study for a randomized controlled trial conducted on 60 patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine after approval of the institutional review board and taking informed written consent from every patient before participation in the study.

To be included in the study, patients should be more than 18 years old, have a history of COVID 19 infection more than three months ago as confirmed by PCR test, have a post COpost-COVIDVID parosmia, and have no history of systemic steroid administration over the last one month. History of previous nasal surgery, underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases), and hypersensitivity to Ivermectin were the exclusion criteria for this study.

Patients of the study will be randomly and equally distributed between case and control groups using block randomization methods using 4 blocks each comprising 4 patients with 6 patterns for every block one of which was selected randomly using random numbers generated by Excel program. Case group will receive a 4 weeks course of Ivermectin 1% in a dose of two drops per each nostril twice daily. Control group will receive a 4 weeks course of local steroids in the form of budesonide (64 µg per puff in a dose of 1 puff for each nostril twice daily.

Assessment protocol:

Patients of the study will be assessed before and at the end of the treatment protocol with history taking to define the inclusion and exclusion criteria. Endoscopic examination of the nasal cavity will be performed to exclude any other intranasal pathology. The degree of parosmia will be assessed using a visual analog scale before and four weeks after treatment.

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
Single (Outcomes Assessor)

盲法说明

The statistician will be blinded to the patient's group

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

  • Patients should be more than 18 years old,
  • Patients having a history of COVID 19 infection more than three months ago as confirmed by PCR test,
  • Patients having a post COVID parosmia,
  • Patients having no history of systemic steroid administration over the last one month.

排除标准

  • History of previous nasal surgery,
  • Underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases),
  • Hypersensitivity to Ivermectin.

研究组 & 干预措施

Control group

Active Comparator

The patients will receive local steroid spray

干预措施: Budesonide Nasal (Drug)

Case group

Experimental

The patients will receive ivermectin nasal drops

干预措施: Ivermectin Topical (Drug)

结局指标

主要结局

Comparison between the pre and post treatment values

时间窗: After one month of treatment

Comparison between the pre and post-treatment values of visual analog scale values for post-COVD-19 parosmia. The values range from 0 to 10 with 10 indicating severe parosmia

Comparison between case and control groups regarding the post treatment results

时间窗: After one month of treatment

Comparison between case and control groups regarding the post treatment results whether no improvement, partial improvement, or complete improvement

次要结局

  • Assessment of the side effects of Ivermectin nasal drops(After one month of treatment)

研究者

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

Ahmad Mahmoud Hamdan

Principal Investigator

Menoufia University

研究点 (1)

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