Association of Androgenetic Alopecia and Severity of Coronavirus Disease 2019 (COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 300 Participants Mean Age
研究概览
简要总结
Coronavirus disease 2019 (COVID-19) can cause variable symptoms ranging from mild common cold-like symptoms to severe life threatening pneumonia. Recent studies show severe outcomes of COVID-19 patients specially in males who suffer from androgenetic alopecia, would be significant and is of particular interest of this study and could help further support the hypothesis that anti-androgen therapy might represents an additional potential intervention against severe COVID-19.
详细描述
INTRODUCTION
An outbreak of Corona virus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-coV-2) occurred in Wuhan city, Hubei province, China in December 2019. Belonging to the family Beta-coronavirus, this virus can cause variable symptoms ranging from mild common cold-like symptoms to severe life threatening pneumonia. Numerous cases of new onset of skin lesions in COVID-19 patients are spreading across the globe. There are also some reports of aggravation of prior skin disorders. While severe COVID-19 symptoms and high mortality primarily manifested in older adults specially adult males, this sexual dimorphism in the severity of COVID-19 patients predisposed possibly due to increased androgen levels particularly in males suffering from androgenetic alopecia (AGA) would be significant and is of particular interest of this study and could help further support the hypothesis that anti-androgen therapy might represents an additional potential intervention against severe COVID-19.
OBJECTIVE
Association of Androgenetic alopecia and severity of Coronavirus disease 2019 (COVID-19).
PLACE OF STUDY: COVID-19 isolation unit of Jinnah postgraduate medical center (JPMC) Karachi, Sindh province, Pakistan.
RESEARCH METHODOLOGY: This study will be conducted on patients admitted in COVID-19 isolation unit of JPMC Karachi. Permission from the institutional ethical review committee will be taken prior to conduction of study, demographic data and written informed consent will be taken from every patient. Sample size of study would be 300 hospitalized patients of COVID-19. Detailed history and examination of patients including be conducted in COVID-19 patients. Scoring of AGA be evaluated using Hamilton-Norwood scale (HNS) in men and Ludwig scale in female. Severity of the COVID-19 be measured by COVID severity score (A-DROP). Study is aimed to evaluate association of AGA and severity of COVID-19, frequency of AGA in covid 19 and whether the lung involvement correlates with the severity of AGA or whether the proportion of AGA is higher in intensive care/fatal COVID-19.
DATA ANALYSIS: Data will be analysed using SPSS version 23 registered for Microsoft windows. Mean and standard deviation will be calculated for expression of quantitative variables like age, weight, duration of disease symptoms. Frequencies and percentages will be calculated for the qualitative variables like gender, co-morbidities, frequency and severity of AGA, disease outcome and AGA associated with severity of COVID-19. Effect modifiers like age, gender, weight, co-morbidities, duration of symptoms will be controlled through stratification. Post-stratification will be recalculated and chi-square test will be applied. P-value of <0.05% will be considered as significant.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients of diagnosed covid-19 age > 20years
- •with or without androgenetic alopecia
- •with or without comorbidities
- •irrespective of disease duration -
排除标准
- 未提供
结局指标
主要结局
300 Participants Mean Age
时间窗: Day 1 of admission
Age of the patient is very important to co-relate with disease outcome and severity of Androgenetic alopecia
Severity of Androgenetic Alopecia in Patients
时间窗: Day 1 of admission
Severity of androgenetic alopecia be measured using Hamilton and norwood scale (HNS) less than 3 or 3-7. In females using ludwig scale: less than 2 or 2-3. Hamilton norwood score: Minimum value 1, maximum value 7. Ludwig score: minimum 0, maximum 3 Mild to moderate: HNS \<3/ Ludwig \<2 Severe: HNS 3-7/ ludwig 2-3
Covid-19 Disease Outcomes Correlating With Severity of Androgenetic Alopecia and Age in Males
时间窗: From date of randomization until the date of clinical improvement (discharge, from ventilator to mask/nasal cannula) or worsening of condtion(from mask/bag to ventilator) or death from any cause, assessed up to 4 months
It is to find out how severily disease outcomes can be affected due to androgeneic alopecia by age accordingly.
Hospital Disease Outcome in 300 Subjects. Having 220 Males and 80 Females
时间窗: Disease outcome during this 4 month duration of study.
Hospital disease outcome as mask, cannnula, ventilator or death in 300 subjects. Having 220 males and 80 Females
Androgenetic Alopecia Frequency in Participants.
时间窗: Day 1 of admission
Frequency of Androgenetic alopecia in patients be noted.
Disease Outcome as Assessed by Number of Participants Experiencing Better or Worst Outcome With Respect to Age Group.
时间窗: From date of randomization until the date of clinical improvement (discharge, from ventilator to mask/nasal cannula) or worsening of condtion(from mask/bag to ventilator) or death from any cause, assessed up to 4 months
Outcome of participants suffering from covid-19 with respect to age group as better outcomes: oxygen mask/bag or nasal cannula Worst outcomes: ventilator or death
Disease Outcome as Assessed by Severity of Androgeneic Alopecia in Males
时间窗: From date of randomization until the date of clinical improvement (discharge, from ventilator to mask/nasal cannula) or worsening of condtion(from mask/bag to ventilator) or death from any cause, assessed up to 4 months
Covid-19 disease outcome assessed by Severity of androgenetic alopecia to find out their correlation
Disease Outcome be Assessed by Severity of Androgenetic Alopecia in Females
时间窗: From date of randomization until the date of clinical improvement (discharge, from ventilator to mask/nasal cannula) or worsening of condtion(from mask/bag to ventilator) or death from any cause, assessed up to 4 months
Covid-19 disease outcome assessed by Severity of androgenetic alopecia to find out their correlation
Covid-19 Disease Outcomes Correlating With Severity of Androgenetic Alopecia and Age in Females.
时间窗: From date of randomization until the date of clinical improvement (discharge, from ventilator to mask/nasal cannula) or worsening of condtion(from mask/bag to ventilator) or death from any cause, assessed up to 4 months
It is to find out how severily disease outcomes can be affected due to androgeneic alopecia by age accordingly.
次要结局
- Disease Duration of COVID-19(Day 1 of admission, till disease outcome in upto 4 months)
- Comorbidities Including Diabetes Mellitus, Smoking, Hypertension, Ischemic Heart Disease, Chronic Kidney Disease, Obesity in Participants(Date of randomization until upto 4 months)
研究者
Syeda Mahanum Ali
Postgraduate trainee dermatology
Jinnah Postgraduate Medical Centre