Role of Corticosteroid Nasal Spray in Recovery of Smell Sensation in COVID-19 Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- improvement of olfaction
研究概览
简要总结
The aim of this study is to evaluate the role of the topical corticosteroids nasal spray (mometasone furoate nasal spray) in improving anosmia in patients recovered from COVID-19 infection.
详细描述
This study willbe submitted on patients who recently recovered from proven COVID-19 infection and complaining of anosmia or hyposmia.The proven COVID-19 infection will be relied on a positive real-time reverse transcription polymerase chain reaction (rRT-PCR) with samples obtained by a nasopharyngeal swab. The recovery is defined as 2 consecutives negative (rRT-PCR) samples.
Complete medical history will be taken, and essential clinical assessment with appropriate protective measures will be performed in all patients.The patients in the study will be randomly divided into two groups: - Group I: -who will receive topical corticosteroid nasal spray (mometasone furoate nasal spray) beside olfactory training Group II: -who will not receive topical corticosteroid nasal spray but only olfactory training.
As regards the assessment of smell,the patient will assess his smell sensation using familiar substances with distinctive odor. A jar of coffee, a branch of mint and garlic are some used substances. The patient will report the degree of anosmia subjectively with score on a scale from 0 to 10.The assessment of smell will be done initially after recovery/discharge, after 1 week, 2 weeks and after 3 weeks for all patients. The duration of smell loss will be recorded from the onset of anosmia till full recovery of the sensation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults 18 yrs or older patients
- •confirmed case (+ve PCR),
- •recovered/discharged (2 -ve PCR),
- •suffered from sudden recent anosmia or hyposmia
排除标准
- •patients already on nasal steroid
- •with previous chronic rhinological pathologies,
- •patients on systemic steroid for previous systemic disease,
- •anosmia improved before COVID19 recovery,
- •pregnancy
- •patients who will not complete the follow up period.
研究组 & 干预措施
mometasone nasal spray
Patients will receive topical corticosteroid nasal spray (mometasone furoate nasal spray) in appropriate dose of 2 puff in each nostril (100 µg once daily) beside olfactory training.
干预措施: mometasone furoate nasal spray (Drug)
结局指标
主要结局
improvement of olfaction
时间窗: 3 weeks
The patient will report the degree of anosmia subjectively with score on a scale from 0 to 10 (0 means total loss of smell and 10 refers to completely normal smell sensation).
次要结局
未报告次要终点
研究者
Abdelrahman Ahmed Abdelalim
MD lecturer
Benha University
