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

NCT ID: NCT04898166

Last Updated: 2021-10-26

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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Covid19 Androgenetic alopecia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Syeda Mahanum Ali

OTHER_GOV

Sponsor Role lead

Responsible Party

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Syeda Mahanum Ali

Postgraduate trainee dermatology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rabia Ghafoor, MBBS, FCPS, SCE-Derm(MRCP-UK)

Role: PRINCIPAL_INVESTIGATOR

Jinnah Postgraduate Medical Centre

Syeda Mahanum Ali, MBBS, Postgraduate Trainee

Role: PRINCIPAL_INVESTIGATOR

Jinnah Postgraduate Medical Centre

Locations

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Jinnah postgraduate medical center

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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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. No abstract available.

Reference Type BACKGROUND
PMID: 32237190 (View on PubMed)

Muller 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. No abstract available.

Reference Type BACKGROUND
PMID: 33098701 (View on PubMed)

Goren A, Vano-Galvan 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.

Reference Type BACKGROUND
PMID: 32301221 (View on PubMed)

Wambier CG, Vano-Galvan S, McCoy J, Gomez-Zubiaur A, Herrera S, Hermosa-Gelbard A, Moreno-Arrones OM, Jimenez-Gomez N, Gonzalez-Cantero A, Fonda-Pascual P, Segurado-Miravalles G, Shapiro J, Perez-Garcia 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.

Reference Type BACKGROUND
PMID: 32446821 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 32333494 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32707256 (View on PubMed)

Wambier CG, Vano-Galvan 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.

Reference Type BACKGROUND
PMID: 32735970 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://pubmed.ncbi.nlm.nih.gov/32237190/

What does androgenetic alopecia have to do with COVID-19? An insight into a potential new therapy

https://pubmed.ncbi.nlm.nih.gov/33098701/

Alopecia and grey hair are associated with COVID-19 Severity

https://pubmed.ncbi.nlm.nih.gov/32301221/

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

https://pubmed.ncbi.nlm.nih.gov/32446821/

Androgenetic alopecia present in the majority of patients hospitalized with COVID-19: The "Gabrin sign"

https://pubmed.ncbi.nlm.nih.gov/32333494/

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?

https://pubmed.ncbi.nlm.nih.gov/32707256/

Male balding is a major risk factor for severe COVID-19

https://pubmed.ncbi.nlm.nih.gov/32735970/

Androgenetic alopecia in COVID-19: Compared to age-matched epidemiologic studies and hospital outcomes with or without the Gabrin sign

Other Identifiers

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NO.F.2-81/2021-GEN/56923/JPMC

Identifier Type: -

Identifier Source: org_study_id