NCT04898166

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

Completed Results posted Last updated 26 October 2021

What this trial tests

trial in Androgenetic Alopecia in 300 participants. Completed in 31 March 2021.

Timeline

1 December 2020

Primary endpoint
31 March 2021

31 March 2021

Quick facts

Lead sponsor	Syeda Mahanum Ali
Status	Completed
Study type	OBSERVATIONAL
Enrollment	300
Start date	1 December 2020
Primary completion	31 March 2021
Estimated completion	31 March 2021
Sites	1 location across Pakistan

Conditions studied

• Androgenetic Alopecia — all drugs for Androgenetic Alopecia →
• Coronavirus Disease 2019 — all drugs for Coronavirus Disease 2019 →
• Covid19 — all drugs for Covid19 →
• Male Pattern Baldness — all drugs for Male Pattern Baldness →

Sponsor

Syeda Mahanum Ali

Who can join

Adults 20 to 100, any sex, with Androgenetic Alopecia or Coronavirus Disease 2019. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Androgenetic Alopecia Frequency in Participants. Primary · Day 1 of admission

Frequency of Androgenetic alopecia in patients be noted.

Group	Value	95% CI
220 Hospitalized Participants Diagnosed Case of COVID-19.	209
80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19	37
220 Hospitalized Participants Diagnosed Case of COVID-19.	11
80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19	43

Severity of Androgenetic Alopecia in Patients Primary · 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

Group	Value	95% CI
220 Hospitalised Male Participants Diagnosed Case of COVID-19.	43
80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19.	9
220 Hospitalised Male Participants Diagnosed Case of COVID-19.	177
80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19.	28

300 Participants Mean Age Primary · Day 1 of admission

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

Group	Value	95% CI
300 Participants Diagnosed Case of Hospitalized COVID-19. Mean Age be Noted	53.06	± 13.495

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

Group	Value	95% CI
220 Hospitalised Male Participants Diagnosed Case of COVID-19.	15
80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19.	10
220 Hospitalised Male Participants Diagnosed Case of COVID-19.	13
80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19.	18
220 Hospitalised Male Participants Diagnosed Case of COVID-19.	13
80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19.	0
220 Hospitalised Male Participants Diagnosed Case of COVID-19.	15
80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19.	4

Disease Outcome as Assessed by Severity of Androgeneic Alopecia in Males Primary · 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

Group	Value	95% CI
220 Hospitalised Male Subjects. Their Disease Outcomes in Relation to Severity of AGA	20
220 Hospitalised Male Subjects. Their Disease Outcomes in Relation to Severity of AGA	52
220 Hospitalised Male Subjects. Their Disease Outcomes in Relation to Severity of AGA	14
220 Hospitalised Male Subjects. Their Disease Outcomes in Relation to Severity of AGA	27

Disease Outcome be Assessed by Severity of Androgenetic Alopecia in Females Primary · 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

Group	Value	95% CI
80 Hospitalised Female Participants. Their Disease Outcomes in Relation to Severity of AGA	9
80 Hospitalised Female Participants. Their Disease Outcomes in Relation to Severity of AGA	3
80 Hospitalised Female Participants. Their Disease Outcomes in Relation to Severity of AGA	4
80 Hospitalised Female Participants. Their Disease Outcomes in Relation to Severity of AGA	17

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

Group	Value	95% CI
37 Hospitalised Female Participants of COVID-19 With Androgenetic Alopecia	0
43 Hospitalised Female Participants of COVID-19 Without Androgenetic Alopecia With Respect to Age	4
37 Hospitalised Female Participants of COVID-19 With Androgenetic Alopecia	7
43 Hospitalised Female Participants of COVID-19 Without Androgenetic Alopecia With Respect to Age	5
37 Hospitalised Female Participants of COVID-19 With Androgenetic Alopecia	00
43 Hospitalised Female Participants of COVID-19 Without Androgenetic Alopecia With Respect to Age	00
37 Hospitalised Female Participants of COVID-19 With Androgenetic Alopecia	3
43 Hospitalised Female Participants of COVID-19 Without Androgenetic Alopecia With Respect to Age	7

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

Group	Value	95% CI
43 Hospitalised Male Participants Diagnosed Case of COVID-19 With HNS <3.	4
177 Hospitalised Male Participants Diagnosed Case of COVID-19 With HNS >3-7	11
43 Hospitalised Male Participants Diagnosed Case of COVID-19 With HNS <3.	10
177 Hospitalised Male Participants Diagnosed Case of COVID-19 With HNS >3-7	27
43 Hospitalised Male Participants Diagnosed Case of COVID-19 With HNS <3.	6
177 Hospitalised Male Participants Diagnosed Case of COVID-19 With HNS >3-7	14
43 Hospitalised Male Participants Diagnosed Case of COVID-19 With HNS <3.	6
177 Hospitalised Male Participants Diagnosed Case of COVID-19 With HNS >3-7	9

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

Group	Value	95% CI
220 Hospitalized Participants Diagnosed Case of COVID-19.	41
80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19	28
220 Hospitalized Participants Diagnosed Case of COVID-19.	72
80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19	16
220 Hospitalized Participants Diagnosed Case of COVID-19.	30
80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19	26
220 Hospitalized Participants Diagnosed Case of COVID-19.	77
80 Hospitalized Female Participants Diagnosed Case of Hospitalized COVID-19	10

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

Group	Value	95% CI
300 Participants Diagnosed Case of Hospitalized COVID-19 Outcome in Relation to Comorbidities	29
300 Participants Diagnosed Case of Hospitalized COVID-19 Outcome in Relation to Comorbidities	6
300 Participants Diagnosed Case of Hospitalized COVID-19 Outcome in Relation to Comorbidities	4
300 Participants Diagnosed Case of Hospitalized COVID-19 Outcome in Relation to Comorbidities	12

Disease Duration of COVID-19 Secondary · Day 1 of admission, till disease outcome in upto 4 months

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

Group	Value	95% CI
300 Participants Diagnosed Case of Hospitalized COVID-19 Disease Duration	11.79	± 5.727

Adverse events — posted to ClinicalTrials.gov

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. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

300 Participants Diagnosed Case of Hospitalized COVID-19 With or Without Androgenetic Alopecia.

Serious: 300/300 (100%)

Deaths: 87/300

Serious adverse events (4 terms)

Reaction	System	300 Participants Diagnosed…
Male and female participants on nasal cannula	Infections and infestations	—
87 male and female participants death	Infections and infestations	—
Male and female participants on oxygen mask/bag	Infections and infestations	—
Male and female participants on ventilator	Infections and infestations	—

Most-reported serious reactions: Male and female participants on nasal cannula, 87 male and female participants death, Male and female participants on oxygen mask/bag, Male and female participants on ventilator.

Data from ClinicalTrials.gov NCT04898166 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.