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

NCT04898166 | Completed Results DMC

• 1 other identifier: NO.F.2-81/2021-GEN/56923/JPMC
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Covid19; Androgenetic alopecia

Outcome Measures

Primary Outcomes (9)

• Androgenetic Alopecia Frequency in Participants.

  Frequency of Androgenetic alopecia in patients be noted.

  Day 1 of admission

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

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

  Date of randomization until upto 4 months

• Disease Duration of COVID-19

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

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalised diagnosed covid-19 patients with or without comorbidities. Irrespective of disease duration. Intensity and frequency of androgenetic alopecia, disease outcome be noted in these patients.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Syeda Mahanum Ali: lead

Study Sites (1)

Jinnah postgraduate medical center

Karachi, Sindh, 75510, Pakistan

Location

Related 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. No abstract available.

  PMID: 32237190 BACKGROUND

• 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.

  PMID: 33098701 BACKGROUND

• 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.

  PMID: 32301221 BACKGROUND

• 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.

  PMID: 32446821 BACKGROUND

• 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.

  PMID: 32333494 BACKGROUND

• 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.

  PMID: 32707256 BACKGROUND

• 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.

  PMID: 32735970 BACKGROUND

Related Links

• What does androgenetic alopecia have to do with COVID-19? An insight into a potential new therapy
• Alopecia and grey hair are associated with COVID-19 Severity
• 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
• Androgenetic alopecia present in the majority of patients hospitalized with COVID-19: The "Gabrin sign"
• 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?
• Male balding is a major risk factor for severe COVID-19
• Androgenetic alopecia in COVID-19: Compared to age-matched epidemiologic studies and hospital outcomes with or without the Gabrin sign

MeSH Terms

Conditions

Alopecia; COVID-19

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Syeda Mahanum Ali
• Organization: Jinnah postgraduate medical centre

mahanumsyed8@gmail.com

03033901112

Study Officials

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

  Jinnah Postgraduate Medical Centre

  PRINCIPAL INVESTIGATOR

• Syeda Mahanum Ali, MBBS, Postgraduate Trainee

  Jinnah Postgraduate Medical Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 4 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postgraduate trainee dermatology

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 24, 2021
• Study Start: December 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: October 26, 2021
• Results First Posted: August 2, 2021

Record last verified: 2021-10

Locations

PA (1)