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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinnah postgraduate medical center | Karachi | Sindh | 75510 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32237190 | Background | 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. | |
| 33098701 | Background |
| Label | URL |
|---|---|
| What does androgenetic alopecia have to do with COVID-19? An insight into a potential new therapy | View source |
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300 participants at COVID-19 isolation unit jinnah postgraduate medical centre karachi.
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| ID | Title | Description |
|---|---|---|
| FG000 | 220 Hospitalized Male Participants Diagnosed Case of COVID-19. | 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. |
| FG001 | 80 Hospitalized Female Participants Diagnosed Case of COVID-19. | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 220 Hospitalized Male Participants Diagnosed Case of COVID-19. | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Androgenetic Alopecia Frequency in Participants. | Frequency of Androgenetic alopecia in patients be noted. | Posted | Count of Participants | Participants | Day 1 of admission |
|
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
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 300 Participants Diagnosed Case of Hospitalized COVID-19 With or Without Androgenetic Alopecia. | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 87 male and female participants death | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Syeda Mahanum Ali | Jinnah postgraduate medical centre | 03033901112 | mahanumsyed8@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2021 | Jul 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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. |
| 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 |
| 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. |
| 32301221 | 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. |
| 32446821 | 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. |
| 32333494 | 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. |
| 32707256 | 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. |
| 32735970 | 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. |
| Alopecia and grey hair are associated with COVID-19 Severity | View source |
| 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 | View source |
| Androgenetic alopecia present in the majority of patients hospitalized with COVID-19: The "Gabrin sign" | View source |
| 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? | View source |
| Male balding is a major risk factor for severe COVID-19 | View source |
| Androgenetic alopecia in COVID-19: Compared to age-matched epidemiologic studies and hospital outcomes with or without the Gabrin sign | View source |
| BG001 |
| 80 Hospitalized Female Participants Diagnosed Case of COVID-19 |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Comorbidities | Count of Participants | Participants |
|
|
|
| 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 | Posted | Count of Participants | Participants | 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 | Posted | Mean | Standard Deviation | years | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | Days | Day 1 of admission, till disease outcome in upto 4 months |
|
|
|
| 87 |
| 300 |
| 300 |
| 300 |
| 0 |
| 300 |
| Male and female participants on ventilator | Infections and infestations | Systematic Assessment |
|
| Male and female participants on oxygen mask/bag | Infections and infestations | Systematic Assessment |
|
| Male and female participants on nasal cannula | Infections and infestations | Systematic Assessment |
|
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Participants on mask/bag with age >60years |
|
| Participants on Nasal cannula with age 20-40years |
|
| Participants on nasal cannula with age >40-60 years |
|
| Participants on nasal cannula with age >60years |
|
| Participants on ventilator with age 20-40years |
|
| Participants on ventilator with age >40-60 years |
|
| Participants on ventilator with age >60years |
|
| Participants death with age 20-40 years |
|
| Participants death with age >40-60 years |
|
| Participants death with age >60years |
|
| Patients on mask/bag with HNS 3-7 |
|
| Patients on ventilator with HNS <3 |
|
| Patients on ventilator with HNS 3-7 |
|
| Patients death with HNS <3 |
|
| Patients death with HNS 3-7 |
|
| Female participants on nasal cannula without androgenetic alopecia |
|
| Female participants on nasal cannula with ludwig scale <2 |
|
| Female participants on nasal cannula with ludwig scale 2-3 |
|
| Female participants on ventilator with no androgenetic alopecia |
|
| Female participants on ventilator with ludwig scale <2 |
|
| Female participants on ventilator with ludwig scale 2-3 |
|
| Female participants death with no androgenetic alopecia |
|
| Female participants death with ludwig scale <2 |
|
| Female participants death with ludwig scale 2-3 |
|
| Age >60yrs nasal cannula |
|
| Age 20-40yrs: mask/bag |
|
| Age >40-60yrs: mask/bag |
|
| Age >60yrs mask/bag |
|
| Age 20-40yrs: ventilator |
|
| Age >40-60yrs: ventilator |
|
| Age >60yrs: ventilator |
|
| Age 20-40yrs: death |
|
| Age >40-60yrs: death |
|
| Age >60yrs: death |
|
| Nasal cannula age >60yrs |
|
| Mask/bag age 20-40yrs |
|
| Mask/bag age >40-60yrs |
|
| Mask/bag age >60yrs |
|
| Ventilator age 20-40yrs |
|
| Ventilator age >40-60yrs |
|
| Ventilator age >60yr |
|
| Death age 20-40yrs |
|
| Death age >40-60yrs |
|
| Death age >60yrs |
|
| Ventilator usage |
|
| Death |
|
| participant on nasal cannula with history of diabetes mellitus |
|
| participant on nasal cannula with history of hypertension |
|
| participant on nasal cannula with history of obesity |
|
| participant on nasal cannula with history of chronic kidney disease |
|
| participant on nasal cannula with history of multiple comorbidities |
|
| participant on mask/bag with no comorbidity |
|
| Participants on mask/bag with history of smoking |
|
| participant on mask/bag with history of history of ischemic heart disease |
|
| participant on mask/bag with history of diabetes mellitus |
|
| participant on mask/bag with history of hypertension |
|
| participant on mask/bag with obesity |
|
| participant on mask/bag with history of chronic kidney disease |
|
| participant on mask/bag with history of multiple comorbidities |
|
| participant on ventilator with no comorbidity |
|
| Participants on Ventilator with history of smoking |
|
| participant on ventilator with history of ischemic heart disease |
|
| participant on ventilator with history of diabetes mellitus |
|
| participant on ventilator with history of hypertension |
|
| participant on ventilator with history of obesity |
|
| participant on Ventilator with history of chronic kidney disease |
|
| participant on ventilator with history of multiple comorbidities |
|
| Participants death with no comorbidity |
|
| participant death with history of smoking |
|
| participant death: history of ischemic heart disease |
|
| participant death with history diabetes mellitus |
|
| participant death with history of hypertension |
|
| participant death with history of obesity |
|
| participant death with history of kidney disease |
|
| participant death with history of multiple comorbidities |
|