Does Oral Isotretinoin Increase the Risk of Developing Infection With and Complications From Covid-19, Compared to an Age-matched Background Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
There is a theoretical risk that the nasal mucosal dryness caused by oral retinoid medications may increase risk of infection with Covid-19. Isotretinoin arrests the cell cycle of mucus secreting cells in the nasal cavity, and cilia and mucus are both believed to have roles in defence against infection and immunity. Hence it was postulated at the start of the pandemic that isotretinoin may increase the likelihood of contracting a disease spread by droplet or aerosol particles.
The investigators planned to compare rates of infection and deterioration between our group of patients taking isotretinoin, aged 16-40years, and the local (NHS Grampian / Moray) age-matched population.
详细描述
Isotretinoin is a drug used commonly in dermatology, usually for management of acne and occasionally for management of other dermatological diseases. The most common side effect of oral isotretinoin is mucocutaneous dryness, which can lead to nasal dryness and crusting. Isotretinoin is derived from vitamin A and produces this side effect by arresting the cell cycle of mucus secreting cells in the nasal cavity. The mucus usually secreted moisturises the nasal cavity and provides a protective, lubricating layer overlying the cilia.
Cilia and nasal mucous are both believed to have roles in defence against infection and immunity. Hence it was postulated at the start of the pandemic that the effect this medication has on the nasal environment may increase the likelihood of contracting a disease spread by droplet or aerosol particles, such as Covid-19.
In March 2020 the investigators established a departmental database of our patients on oral retinoid medications in order to track those currently receiving treatment. The database includes people taking isotretinoin, alitretinoin and acitretin. The greatest number of patients in this database are in the isotretinoin group and patients taking isotretinoin tend to be a relatively young and fit population. Acitretin on the other hand is often used in an older population who may have other underlying disease comorbidities. There were only a very small number of patients taking alitretinoin in the database.
In order to limit confounding variables and provide as clear a result as possible, it was decided to limit this study to comparing the group of patients taking isotretinoin, aged 16-40years, and compare their rates per 100000 of infection and deterioration with the age-matched local population from NHS Grampian & Moray catchment.
This study would examine the electronic patient record of patients aged 16-40years, taking isotretinoin between March and October 2020 and compare their rates of Covid-19 infection, hospitalisation and complications with the rates of the local age-matched background population. In initial protocols, prior to data being obtained, persons taking isotretinoin in the time period were to be excluded from the background population - unfortunately on obtaining the data, which could only be achieved after this protocol was originally written, it was not possible to exclude those taking isotretinoin, therefore the isotretinoin population's rates were to be compared against the age-matched local population as a whole.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 40 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Test: prescribed oral isotretinoin in NHS Grampian age 16-40years inclusive, between March-Oct 2020
- •Background control population: residing in NHS Grampian including Moray catchment, age 16-40years, (this was found to be n=189633 people).
排除标准
- •Test population: not prescribed oral isotretinoin in NHS grampian, outwith age range 16-40years or treatment range March-October
- •Background control population: age outwith 16-40years, not resident in NHS Grampian / Moray catchment.
研究组 & 干预措施
Isotretinoin
Test population, prescribed oral isotretinoin between March and October 2020.
Control
Background age-matched local population (NHS Grampian including Moray) during March to October 2020
结局指标
主要结局
Primary Outcome
时间窗: March - October 2020
Did patients taking isotretinoin have a greater risk of infection with Covid-19 compared to the age-matched local population. Rates per 100000 of covid testing and positive results indicating covid infection were compared between a cohort taking isotretinoin, and the age matched local (NHS Grampian \&Moray) population.
次要结局
- Secondary Outcome(March - October 2020)
