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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04898166
• Other study ID #: NO.F.2-81/2021-GEN/56923/JPMC
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: October 2021
• Source: Jinnah Postgraduate Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia
• Coronavirus Disease 2019
• Coronavirus Infections
• COVID-19
• COVID-19 Pneumonia
• Covid19
• Female Pattern Baldness
• Male Pattern Baldness

Locations

Country	Name	City	State
Pakistan	Jinnah postgraduate medical center	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Syeda Mahanum Ali

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

Goren A, McCoy J, Wambier CG, Vano-Galvan S, Shapiro J, Dhurat R, Washenik K, Lotti T. What does androgenetic alopecia have to do with COVID-19? An insight into a potential new therapy. Dermatol Ther. 2020 Jul;33(4):e13365. doi: 10.1111/dth.13365. Epub 2020 Apr 8. — View Citation

Goren A, Vaño-Galván S, Wambier CG, McCoy J, Gomez-Zubiaur A, Moreno-Arrones OM, Shapiro J, Sinclair RD, Gold MH, Kovacevic M, Mesinkovska NA, Goldust M, Washenik K. A preliminary observation: Male pattern hair loss among hospitalized COVID-19 patients in Spain - A potential clue to the role of androgens in COVID-19 severity. J Cosmet Dermatol. 2020 Jul;19(7):1545-1547. doi: 10.1111/jocd.13443. Epub 2020 Apr 23. — View Citation

Lee J, Yousaf A, Fang W, Kolodney MS. Male balding is a major risk factor for severe COVID-19. J Am Acad Dermatol. 2020 Nov;83(5):e353-e354. doi: 10.1016/j.jaad.2020.07.062. Epub 2020 Jul 22. Erratum in: J Am Acad Dermatol. 2021 Sep;85(3):799. — View Citation

McCoy J, Wambier CG, Vano-Galvan S, Shapiro J, Sinclair R, Ramos PM, Washenik K, Andrade M, Herrera S, Goren A. Racial variations in COVID-19 deaths may be due to androgen receptor genetic variants associated with prostate cancer and androgenetic alopecia. Are anti-androgens a potential treatment for COVID-19? J Cosmet Dermatol. 2020 Jul;19(7):1542-1543. doi: 10.1111/jocd.13455. Epub 2020 Jun 14. — View Citation

Müller Ramos P, Ianhez M, Amante Miot H. Alopecia and grey hair are associated with COVID-19 Severity. Exp Dermatol. 2020 Dec;29(12):1250-1252. doi: 10.1111/exd.14220. Epub 2020 Nov 18. — View Citation

Wambier CG, Vaño-Galván S, McCoy J, Gomez-Zubiaur A, Herrera S, Hermosa-Gelbard Á, Moreno-Arrones OM, Jiménez-Gómez N, González-Cantero A, Fonda-Pascual P, Segurado-Miravalles G, Shapiro J, Pérez-García B, Goren A. Androgenetic alopecia present in the majority of patients hospitalized with COVID-19: The "Gabrin sign". J Am Acad Dermatol. 2020 Aug;83(2):680-682. doi: 10.1016/j.jaad.2020.05.079. Epub 2020 May 22. — View Citation

Wambier CG, Vaño-Galván S, McCoy J, Pai S, Dhurat R, Goren A. Androgenetic alopecia in COVID-19: Compared to age-matched epidemiologic studies and hospital outcomes with or without the Gabrin sign. J Am Acad Dermatol. 2020 Dec;83(6):e453-e454. doi: 10.1016/j.jaad.2020.07.099. Epub 2020 Jul 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Androgenetic Alopecia Frequency in Participants.	Frequency of Androgenetic alopecia in patients be noted.	Day 1 of admission
Primary	Severity of Androgenetic Alopecia in Patients	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	Day 1 of admission
Primary	300 Participants Mean Age	Age of the patient is very important to co-relate with disease outcome and severity of Androgenetic alopecia	Day 1 of admission
Primary	Disease Outcome as Assessed by Number of Participants Experiencing Better or Worst Outcome With Respect to Age Group.	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	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
Primary	Disease Outcome as Assessed by Severity of Androgeneic Alopecia in Males	Covid-19 disease outcome assessed by Severity of androgenetic alopecia to find out their correlation	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
Primary	Disease Outcome be Assessed by Severity of Androgenetic Alopecia in Females	Covid-19 disease outcome assessed by Severity of androgenetic alopecia to find out their correlation	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
Primary	Covid-19 Disease Outcomes Correlating With Severity of Androgenetic Alopecia and Age in Females.	It is to find out how severily disease outcomes can be affected due to androgeneic alopecia by age accordingly.	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
Primary	Covid-19 Disease Outcomes Correlating With Severity of Androgenetic Alopecia and Age in Males	It is to find out how severily disease outcomes can be affected due to androgeneic alopecia by age accordingly.	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
Primary	Hospital Disease Outcome in 300 Subjects. Having 220 Males and 80 Females	Hospital disease outcome as mask, cannnula, ventilator or death in 300 subjects. Having 220 males and 80 Females	Disease outcome during this 4 month duration of study.
Secondary	Comorbidities Including Diabetes Mellitus, Smoking, Hypertension, Ischemic Heart Disease, Chronic Kidney Disease, Obesity in Participants	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.	Date of randomization until upto 4 months
Secondary	Disease Duration of COVID-19	Duration of symptoms patients experiencing from the onset of symptoms till outcome.	Day 1 of admission, till disease outcome in upto 4 months

External Links

•   A preliminary observation: Male pattern hair loss among hospitalized COVID-19 patients in Spain - A potential clue to the role of androgens in COVID-19 severity
•   Alopecia and grey hair are associated with COVID-19 Severity
•   Androgenetic alopecia in COVID-19: Compared to age-matched epidemiologic studies and hospital outcomes with or without the Gabrin sign
•   Androgenetic alopecia present in the majority of patients hospitalized with COVID-19: The "Gabrin sign"
•   Male balding is a major risk factor for severe COVID-19
•   Racial variations in COVID-19 deaths may be due to androgen receptor genetic variants associated with prostate cancer and androgenetic alopecia. Are anti-androgens a potential treatment for COVID-19?
•   What does androgenetic alopecia have to do with COVID-19? An insight into a potential new therapy