Association of Androgenetic Alopecia and Severity of Coronavirus Disease 2019 (COVID-19).
Sponsor
Syeda Mahanum Ali (Other)
Overall Status
Completed
CT.gov ID
NCT04898166
Collaborator
(none)
300
1
3.9
76.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed 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.
Study Design
Study Type:
Observational [Patient Registry]
Actual Enrollment
:
300 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Association of Androgenetic Alopecia and Severity of Coronavirus Disease 2019 (COVID-19)
Actual Study Start Date
:
Dec 1, 2020
Actual Primary Completion Date
:
Mar 31, 2021
Actual Study Completion Date
:
Mar 31, 2021
Outcome Measures
Primary Outcome Measures
- Androgenetic Alopecia Frequency in Participants. [Day 1 of admission]
Frequency of Androgenetic alopecia in patients be noted.
- Severity of Androgenetic Alopecia in Patients [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
- 300 Participants Mean Age [Day 1 of admission]
Age of the patient is very important to co-relate with disease outcome and severity of Androgenetic alopecia
- Disease Outcome as Assessed by Number of Participants Experiencing Better or Worst Outcome With Respect to Age Group. [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 [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 [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. [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.
- Covid-19 Disease Outcomes Correlating With Severity of Androgenetic Alopecia and Age in Males [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 [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 Outcome Measures
- Comorbidities Including Diabetes Mellitus, Smoking, Hypertension, Ischemic Heart Disease, Chronic Kidney Disease, Obesity in Participants [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.
- Disease Duration of COVID-19 [Day 1 of admission, till disease outcome in upto 4 months]
Duration of symptoms patients experiencing from the onset of symptoms till outcome.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 100 Years
Sexes Eligible for Study:
All
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jinnah postgraduate medical center | Karachi | Sindh | Pakistan | 75510 |
Sponsors and Collaborators
- Syeda Mahanum Ali
Investigators
- Principal Investigator: Rabia Ghafoor, MBBS, FCPS, SCE-Derm(MRCP-UK), Jinnah Postgraduate Medical Centre
- Principal Investigator: Syeda Mahanum Ali, MBBS, Postgraduate Trainee, Jinnah Postgraduate Medical Centre
Study Documents (Full-Text)
More Information
Additional Information:
- 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
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
Syeda Mahanum Ali,
Postgraduate trainee dermatology,
Jinnah Postgraduate Medical Centre
ClinicalTrials.gov Identifier:
NCT04898166
Other Study ID Numbers:
- NO.F.2-81/2021-GEN/56923/JPMC
First Posted:
May 24, 2021
Last Update Posted:
Oct 26, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Syeda Mahanum Ali,
Postgraduate trainee dermatology,
Jinnah Postgraduate Medical Centre
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 300 participants at COVID-19 isolation unit jinnah postgraduate medical centre karachi. |
|---|---|
| Pre-assignment Detail | 300 participants signed consent for participation. 300 participants assigned for the study. |
| Arm/Group Title | 220 Hospitalized Male Participants Diagnosed Case of COVID-19. | 80 Hospitalized Female Participants Diagnosed Case of COVID-19. |
|---|---|---|
| Arm/Group Description | 220 hospitalised male participants diagnosed case of COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught Hamilton norwood scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. | 80 hospitalized female Participants diagnosed case of hospitalized COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught ludwig scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. |
| Period Title: Overall Study | ||
| STARTED | 220 | 80 |
| COMPLETED | 220 | 80 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 220 Hospitalized Male Participants Diagnosed Case of COVID-19. | 80 Hospitalized Female Participants Diagnosed Case of COVID-19 | Total |
|---|---|---|---|
| Arm/Group Description | 220 hospitalized male Participants diagnosed case of COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught Hamilton norwood scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. | 80 hospitalized female Participants diagnosed case of COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught ludwig scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. | Total of all reporting groups |
| Overall Participants | 220 | 80 | 300 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
53.39
(14.928)
|
52.17
(8.391)
|
53.06
(13.5)
|
| Age, Customized (Count of Participants) | |||
| Between 20 to 40 years |
41
18.6%
|
29
36.3%
|
70
23.3%
|
| Between >40 to 60 years |
99
45%
|
51
63.8%
|
150
50%
|
| >60 years |
80
36.4%
|
00
0%
|
80
26.7%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
00
0%
|
80
100%
|
80
26.7%
|
| Male |
220
100%
|
00
0%
|
220
73.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
00
0%
|
00
0%
|
0
0%
|
| Not Hispanic or Latino |
220
100%
|
80
100%
|
300
100%
|
| Unknown or Not Reported |
00
0%
|
00
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||
| Pakistan |
220
100%
|
80
100%
|
300
100%
|
| Comorbidities (Count of Participants) | |||
| Smoking |
14
6.4%
|
2
2.5%
|
16
5.3%
|
| Ischemic heart disease |
12
5.5%
|
4
5%
|
16
5.3%
|
| Diabetes mellitus |
35
15.9%
|
17
21.3%
|
52
17.3%
|
| Hypertension |
34
15.5%
|
17
21.3%
|
51
17%
|
| Obesity |
15
6.8%
|
6
7.5%
|
21
7%
|
| Chronic kidney disease |
10
4.5%
|
5
6.3%
|
15
5%
|
| Multiple comorbidities |
20
9.1%
|
19
23.8%
|
39
13%
|
| No comorbidity |
82
37.3%
|
10
12.5%
|
92
30.7%
|
Outcome Measures
| Title | Androgenetic Alopecia Frequency in Participants. |
|---|---|
| Description | Frequency of Androgenetic alopecia in patients be noted. |
| Time Frame | Day 1 of admission |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 220 Hospitalized Participants Diagnosed Case of COVID-19. | 80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19 |
|---|---|---|
| Arm/Group Description | 220 hospitalised male participants diagnosed case of COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught Hamilton norwood scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. | 80 hospitalized female Participants diagnosed case of hospitalized COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught ludwig scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. |
| Measure Participants | 220 | 80 |
| With androgenetic alopecia |
209
95%
|
37
46.3%
|
| Without androgenetic alopecia |
11
5%
|
43
53.8%
|
| Title | Severity of Androgenetic Alopecia in Patients |
|---|---|
| Description | 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 |
| Time Frame | Day 1 of admission |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 220 Hospitalised Male Participants Diagnosed Case of COVID-19. | 80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19. |
|---|---|---|
| Arm/Group Description | 220 hospitalised male participants diagnosed case of COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught Hamilton norwood scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. | 80 hospitalized female Participants diagnosed case of hospitalized COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught ludwig scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death |
| Measure Participants | 220 | 37 |
| Mild to moderate |
43
19.5%
|
9
11.3%
|
| Severe |
177
80.5%
|
28
35%
|
| Title | 300 Participants Mean Age |
|---|---|
| Description | Age of the patient is very important to co-relate with disease outcome and severity of Androgenetic alopecia |
| Time Frame | Day 1 of admission |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 300 Participants Diagnosed Case of Hospitalized COVID-19. Mean Age be Noted |
|---|---|
| Arm/Group Description | 300 Participants diagnosed case of hospitalized COVID-19. Mean age be noted in both males and females |
| Measure Participants | 300 |
| Mean (Standard Deviation) [years] |
53.06
(13.495)
|
| Title | Disease Outcome as Assessed by Number of Participants Experiencing Better or Worst Outcome With Respect to Age Group. |
|---|---|
| Description | 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 |
| 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 Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 220 Hospitalised Male Participants Diagnosed Case of COVID-19. | 80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19. |
|---|---|---|
| Arm/Group Description | 220 hospitalised male participants diagnosed case of COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught Hamilton norwood scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. | 80 hospitalized female Participants diagnosed case of hospitalized COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught ludwig scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death |
| Measure Participants | 220 | 80 |
| Participants on mask/bag with age 20-40years |
15
6.8%
|
10
12.5%
|
| Participants on mask/bag with age >40-60 years |
13
5.9%
|
18
22.5%
|
| Participants on mask/bag with age >60years |
13
5.9%
|
0
0%
|
| Participants on Nasal cannula with age 20-40years |
15
6.8%
|
4
5%
|
| Participants on nasal cannula with age >40-60 years |
37
16.8%
|
12
15%
|
| Participants on nasal cannula with age >60years |
20
9.1%
|
0
0%
|
| Participants on ventilator with age 20-40years |
4
1.8%
|
11
13.8%
|
| Participants on ventilator with age >40-60 years |
16
7.3%
|
15
18.8%
|
| Participants on ventilator with age >60years |
10
4.5%
|
0
0%
|
| Participants death with age 20-40 years |
7
3.2%
|
4
5%
|
| Participants death with age >40-60 years |
33
15%
|
6
7.5%
|
| Participants death with age >60years |
37
16.8%
|
0
0%
|
| Title | Disease Outcome as Assessed by Severity of Androgeneic Alopecia in Males |
|---|---|
| Description | Covid-19 disease outcome assessed by Severity of androgenetic alopecia to find out their correlation |
| 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 Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 220 Hospitalised Male Subjects. Their Disease Outcomes in Relation to Severity of AGA |
|---|---|
| Arm/Group Description | 220 hospitalised male participants diagnosed case of COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of Androgenetic alopecia be noted throught Hamilton norwood scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. Their disease outcomes in relation to severity of AGA |
| Measure Participants | 220 |
| Patients on nasal cannula with HNS <3 |
20
9.1%
|
| Patients on nasal cannula with HNS 3-7 |
52
23.6%
|
| Patients on mask/bag with HNS <3 |
14
6.4%
|
| Patients on mask/bag with HNS 3-7 |
27
12.3%
|
| Patients on ventilator with HNS <3 |
5
2.3%
|
| Patients on ventilator with HNS 3-7 |
25
11.4%
|
| Patients death with HNS <3 |
4
1.8%
|
| Patients death with HNS 3-7 |
73
33.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 220 Hospitalized Participants Diagnosed Case of COVID-19. |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.000 |
| Comments | ||
| Method | Chi-squared | |
| Comments | Chi-square value 18.90 and its asymptotic significance .000 | |
| Title | Disease Outcome be Assessed by Severity of Androgenetic Alopecia in Females |
|---|---|
| Description | Covid-19 disease outcome assessed by Severity of androgenetic alopecia to find out their correlation |
| 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 Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 80 Hospitalised Female Participants. Their Disease Outcomes in Relation to Severity of AGA |
|---|---|
| Arm/Group Description | 80 hospitalised female participants diagnosed case of COVID-19. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught ludwig scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. Their disease outcomes in relation to severity of AGA |
| Measure Participants | 80 |
| Female participants on mask/bag with no androgenetic alopecia |
9
4.1%
|
| Female participants on mask/bag with ludwig scale <2 |
3
1.4%
|
| Female participants on mask/bag with ludwig scale 2-3 |
4
1.8%
|
| Female participants on nasal cannula without androgenetic alopecia |
17
7.7%
|
| Female participants on nasal cannula with ludwig scale <2 |
3
1.4%
|
| Female participants on nasal cannula with ludwig scale 2-3 |
8
3.6%
|
| Female participants on ventilator with no androgenetic alopecia |
14
6.4%
|
| Female participants on ventilator with ludwig scale <2 |
3
1.4%
|
| Female participants on ventilator with ludwig scale 2-3 |
9
4.1%
|
| Female participants death with no androgenetic alopecia |
3
1.4%
|
| Female participants death with ludwig scale <2 |
0
0%
|
| Female participants death with ludwig scale 2-3 |
7
3.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 220 Hospitalized Participants Diagnosed Case of COVID-19. |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.081 |
| Comments | ||
| Method | Chi-squared | |
| Comments | Chi-square value 7.544 and its asymptotic significance .273 | |
| Title | Covid-19 Disease Outcomes Correlating With Severity of Androgenetic Alopecia and Age in Females. |
|---|---|
| Description | It is to find out how severily disease outcomes can be affected due to androgeneic alopecia by age accordingly. |
| 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 Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 37 Hospitalised Female Participants of COVID-19 With Androgenetic Alopecia | 43 Hospitalised Female Participants of COVID-19 Without Androgenetic Alopecia With Respect to Age |
|---|---|---|
| Arm/Group Description | 37 hospitalised female participants diagnosed case of COVID-19 presence of absence of androgenetic alopecia influencing outcome be noted as patient on mask/bag, nasal cannula, ventilator or death with respec to aget | 43 hospitalised female participants diagnosed case of COVID-19 with androgenetic alopecia. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death with respect to age |
| Measure Participants | 37 | 43 |
| Age 20-40yrs: nasal cannula |
0
0%
|
4
5%
|
| Age >40-60yrs: nasal cannula |
7
3.2%
|
5
6.3%
|
| Age >60yrs nasal cannula |
00
0%
|
00
0%
|
| Age 20-40yrs: mask/bag |
3
1.4%
|
7
8.8%
|
| Age >40-60yrs: mask/bag |
8
3.6%
|
10
12.5%
|
| Age >60yrs mask/bag |
00
0%
|
00
0%
|
| Age 20-40yrs: ventilator |
6
2.7%
|
5
6.3%
|
| Age >40-60yrs: ventilator |
6
2.7%
|
9
11.3%
|
| Age >60yrs: ventilator |
00
0%
|
00
0%
|
| Age 20-40yrs: death |
3
1.4%
|
1
1.3%
|
| Age >40-60yrs: death |
4
1.8%
|
2
2.5%
|
| Age >60yrs: death |
00
0%
|
00
0%
|
| Title | Covid-19 Disease Outcomes Correlating With Severity of Androgenetic Alopecia and Age in Males |
|---|---|
| Description | It is to find out how severily disease outcomes can be affected due to androgeneic alopecia by age accordingly. |
| 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 Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 43 Hospitalised Male Participants Diagnosed Case of COVID-19 With HNS <3. | 177 Hospitalised Male Participants Diagnosed Case of COVID-19 With HNS >3-7 |
|---|---|---|
| Arm/Group Description | 43 hospitalised male participants diagnosed case of COVID-19 with HNS <3. Presence or absence of androgenetic alopecia be noted. Severity of androgeneic be noted throught Hamilton norwood scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death with respect to age | 177 hospitalised male participants diagnosed case of COVID-19 with HNS 3-7. Severity of androgeneic be noted throught Hamilton norwood scale. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death with respect to age |
| Measure Participants | 43 | 177 |
| Nasal cannula Age 20-40yrs |
4
1.8%
|
11
13.8%
|
| Nasal cannula age >40-60yrs |
10
4.5%
|
27
33.8%
|
| Nasal cannula age >60yrs |
6
2.7%
|
14
17.5%
|
| Mask/bag age 20-40yrs |
6
2.7%
|
9
11.3%
|
| Mask/bag age >40-60yrs |
5
2.3%
|
8
10%
|
| Mask/bag age >60yrs |
3
1.4%
|
10
12.5%
|
| Ventilator age 20-40yrs |
1
0.5%
|
3
3.8%
|
| Ventilator age >40-60yrs |
2
0.9%
|
14
17.5%
|
| Ventilator age >60yr |
2
0.9%
|
8
10%
|
| Death age 20-40yrs |
0
0%
|
7
8.8%
|
| Death age >40-60yrs |
1
0.5%
|
32
40%
|
| Death age >60yrs |
3
1.4%
|
34
42.5%
|
| Title | Hospital Disease Outcome in 300 Subjects. Having 220 Males and 80 Females |
|---|---|
| Description | Hospital disease outcome as mask, cannnula, ventilator or death in 300 subjects. Having 220 males and 80 Females |
| Time Frame | Disease outcome during this 4 month duration of study. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 220 Hospitalized Participants Diagnosed Case of COVID-19. | 80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19 |
|---|---|---|
| Arm/Group Description | 220 hospitalised male participants diagnosed case of COVID-19. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. | 80 hospitalized female Participants diagnosed case of hospitalized COVID-19. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. |
| Measure Participants | 220 | 80 |
| Mask/bag |
41
18.6%
|
28
35%
|
| Nasal cannula |
72
32.7%
|
16
20%
|
| Ventilator usage |
30
13.6%
|
26
32.5%
|
| Death |
77
35%
|
10
12.5%
|
| Title | Comorbidities Including Diabetes Mellitus, Smoking, Hypertension, Ischemic Heart Disease, Chronic Kidney Disease, Obesity in Participants |
|---|---|
| Description | 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. |
| Time Frame | Date of randomization until upto 4 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 300 Participants Diagnosed Case of Hospitalized COVID-19 Outcome in Relation to Comorbidities |
|---|---|
| Arm/Group Description | 300 Participants diagnosed case of hospitalized COVID-19. 220 males and 80 females. Presence or absence of comorbidities. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. |
| Measure Participants | 300 |
| participant on nasal cannula with no comorbidity |
29
13.2%
|
| participant on nasal cannula with history of smoking |
6
2.7%
|
| participant on nasal cannula with history of ischemic heart disease |
4
1.8%
|
| participant on nasal cannula with history of diabetes mellitus |
12
5.5%
|
| participant on nasal cannula with history of hypertension |
15
6.8%
|
| participant on nasal cannula with history of obesity |
8
3.6%
|
| participant on nasal cannula with history of chronic kidney disease |
5
2.3%
|
| participant on nasal cannula with history of multiple comorbidities |
9
4.1%
|
| participant on mask/bag with no comorbidity |
20
9.1%
|
| Participants on mask/bag with history of smoking |
6
2.7%
|
| participant on mask/bag with history of history of ischemic heart disease |
1
0.5%
|
| participant on mask/bag with history of diabetes mellitus |
15
6.8%
|
| participant on mask/bag with history of hypertension |
8
3.6%
|
| participant on mask/bag with obesity |
6
2.7%
|
| participant on mask/bag with history of chronic kidney disease |
4
1.8%
|
| participant on mask/bag with history of multiple comorbidities |
9
4.1%
|
| participant on ventilator with no comorbidity |
17
7.7%
|
| Participants on Ventilator with history of smoking |
1
0.5%
|
| participant on ventilator with history of ischemic heart disease |
2
0.9%
|
| participant on ventilator with history of diabetes mellitus |
7
3.2%
|
| participant on ventilator with history of hypertension |
10
4.5%
|
| participant on ventilator with history of obesity |
6
2.7%
|
| participant on Ventilator with history of chronic kidney disease |
1
0.5%
|
| participant on ventilator with history of multiple comorbidities |
12
5.5%
|
| Participants death with no comorbidity |
26
11.8%
|
| participant death with history of smoking |
1
0.5%
|
| participant death: history of ischemic heart disease |
9
4.1%
|
| participant death with history diabetes mellitus |
18
8.2%
|
| participant death with history of hypertension |
18
8.2%
|
| participant death with history of obesity |
1
0.5%
|
| participant death with history of kidney disease |
5
2.3%
|
| participant death with history of multiple comorbidities |
9
4.1%
|
| Title | Disease Duration of COVID-19 |
|---|---|
| Description | Duration of symptoms patients experiencing from the onset of symptoms till outcome. |
| Time Frame | Day 1 of admission, till disease outcome in upto 4 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 300 Participants Diagnosed Case of Hospitalized COVID-19 Disease Duration |
|---|---|
| Arm/Group Description | 300 Participants diagnosed case of hospitalized COVID-19 mean and standard deviation of disease duration. |
| Measure Participants | 300 |
| Mean (Standard Deviation) [Days] |
11.79
(5.727)
|
Adverse Events
| Time Frame | From date of randomization until the date of clinical improvement (discharge, from ventilator to mask/nasal cannula) or worsening of condition(from mask/bag to ventilator) or death from any cause, assessed up to 4 months | |
|---|---|---|
| Adverse Event Reporting Description | Our participants are hospitalized COVID-19 patients. Their adverse events are categorised as on oxygen mask/bag,nasal cannula, ventilator or death. Other non serious adverse events are zero because all of our participants were having covid19 so they faced it's symptom and no any other adverse event separately | |
| Arm/Group Title | 300 Participants Diagnosed Case of Hospitalized COVID-19 With or Without Androgenetic Alopecia. | |
| Arm/Group Description | 300 Participants diagnosed case of hospitalized COVID-19. 220 males and 80 females. Presence or absence of androgenetic alopecia be noted in males and females. Severity of androgeneic throught be noted throught Hamilton norwood score and ludwig score, respectively. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. | |
All Cause Mortality |
||
| 300 Participants Diagnosed Case of Hospitalized COVID-19 With or Without Androgenetic Alopecia. | ||
| Affected / at Risk (%) | # Events | |
| Total | 87/300 (29%) | |
Serious Adverse Events |
||
| 300 Participants Diagnosed Case of Hospitalized COVID-19 With or Without Androgenetic Alopecia. | ||
| Affected / at Risk (%) | # Events | |
| Total | 300/300 (100%) | |
| Infections and infestations | ||
| 87 male and female participants death | 87/300 (29%) | |
| Male and female participants on ventilator | 56/300 (18.7%) | |
| Male and female participants on oxygen mask/bag | 69/300 (23%) | |
| Male and female participants on nasal cannula | 88/300 (29.3%) | |
Other (Not Including Serious) Adverse Events |
||
| 300 Participants Diagnosed Case of Hospitalized COVID-19 With or Without Androgenetic Alopecia. | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/300 (0%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Syeda Mahanum Ali |
|---|---|
| Organization | Jinnah postgraduate medical centre |
| Phone | 03033901112 |
| mahanumsyed8@gmail.com |
Responsible Party:
Syeda Mahanum Ali,
Postgraduate trainee dermatology,
Jinnah Postgraduate Medical Centre
ClinicalTrials.gov Identifier:
NCT04898166
Other Study ID Numbers:
- NO.F.2-81/2021-GEN/56923/JPMC
First Posted:
May 24, 2021
Last Update Posted:
Oct 26, 2021
Last Verified:
Oct 1, 2021