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Completed

NCT Number: NCT04898166

Association of Androgenetic Alopecia and Severity of Coronavirus Disease 2019 (COVID-19).

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.

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Key information

Conditions

Androgenetic Alopecia Alopecia COVID-19 COVID-19 Pneumonia Coronaviridae Infections Coronavirus Disease 2019 Coronavirus Infections Covid19 Female Pattern Baldness Hair Diseases Hypotrichosis Infections Lung Diseases Male Pattern Baldness Nidovirales Infections Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Skin Diseases Skin and Connective Tissue Diseases Virus Diseases

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jinnah postgraduate medical center

Karachi, Sindh, 75510, Pakistan

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized patients of diagnosed covid-19 age > 20years
  • with or without androgenetic alopecia
  • with or without comorbidities
  • irrespective of disease duration -

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Androgenetic Alopecia Frequency in Participants.

    Time frame: Day 1 of admission

    Frequency of Androgenetic alopecia in patients be noted.

  2. Severity of Androgenetic Alopecia in Patients

    Time frame: 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

  3. 300 Participants Mean Age

    Time frame: Day 1 of admission

    Age of the patient is very important to co-relate with disease outcome and severity of Androgenetic alopecia

  4. Disease Outcome as Assessed by Number of Participants Experiencing Better or Worst Outcome With Respect to Age Group.

    Time frame: 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

  5. Disease Outcome as Assessed by Severity of Androgeneic Alopecia in Males

    Time frame: 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

  6. Disease Outcome be Assessed by Severity of Androgenetic Alopecia in Females

    Time frame: 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

  7. Covid-19 Disease Outcomes Correlating With Severity of Androgenetic Alopecia and Age in Females.

    Time frame: 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.

  8. Covid-19 Disease Outcomes Correlating With Severity of Androgenetic Alopecia and Age in Males

    Time frame: 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.

  9. Hospital Disease Outcome in 300 Subjects. Having 220 Males and 80 Females

    Time frame: 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

Secondary outcomes

  1. Comorbidities Including Diabetes Mellitus, Smoking, Hypertension, Ischemic Heart Disease, Chronic Kidney Disease, Obesity in Participants

    Time frame: Date of randomization until upto 4 months

    Comorbidities in patients suffering from covid-19 is of great value as it affects disease outcome.number of patients suffrring from comorbidities eg: diabetes mellitus, smoking, hypertension, ischemic heart disease, chronic kidney disease, obesity.

  2. Disease Duration of COVID-19

    Time frame: Day 1 of admission, till disease outcome in upto 4 months

    Duration of symptoms patients experiencing from the onset of symptoms till outcome.

Sponsors and collaborators

Lead sponsor

Syeda Mahanum Ali

Other Gov

Registry information

Official study title

Association of Androgenetic Alopecia and Severity of Coronavirus Disease 2019 (COVID-19)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 24, 2021
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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