Cutaneous Manifestations of Coronavirus Disease 2019(COVID-19).

Study Overview
=================
Brief Summary
-----------------
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. Pulmonary health has been the main focus of studies of COVID-19, current articles show that cutaneous signs appear in COVID-19 patients, their identification may be vital to early diagnosis and lead to possible better prognosis in COVID-19 patients

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. Although pulmonary health has been the main focus of studies, recent studies show that cutaneous symptoms appear in COVID-19 patients, with differing levels of severity even in those patients who were once thought to be asymptomatic to the infection. Recent studies show association of skin manifestations of COVID-19 with severity of COVID-19 infection, which These days, ongoing interest of clinical trials. Although not much is known concerning the pathophysiologic mechanisms of these cutaneous manifestations, their identification may be vital to early diagnosis and lead to possible better prognosis in COVID-19 patients. OBJECTIVE: To examine cutaneous manifestations of Coronavirus Disease-19 (COVID-19). PLACE OF STUDY: Department of Dermatology Jinnah Postgraduate Medical Centre (JPMC) Karachi, Sindh, Pakistan. RESEARCH METHODOLOGY: The longitudinal study will be conducted on patients with COVID-19 at JPMC Karachi. Permission from the ethical review committee will be taken prior to conduction of study and demographic data and informed consent will be taken from every patient or their guardians. forr data collection non-probability convenience sampling method will be used. Sample size of study would be 1206 polymerase chain reaction (PCR) for SARS-CoV-2 RNA positive patients. Detailed history and examination of patients including cutaneous examination be conducted in COVID-19 patients by dermatologists. The data would include gender, age at the time of onset of COVID-19, presence/ absence of comorbidities, the presence/absence of cutaneous manifestation, cutaneous patterns, the duration of skin manifestations, presence or absence of systemic symptoms, skin-related symptoms, type of systemic symptoms, the duration of systemic symptoms, the time of onset of skin manifestation, the latency between the systemic symptoms and cutaneous manifestations, and the COVID-19 severity ( mild/asymptomatic (gastrointestinal symptoms, cough or fever) moderate (dyspnea or pneumonia on x-ray) or severe (death, thromboembolic event or ventilator). The lab-confirmed COVID-19 patients 20 years of age or older irrespect of symptoms were included. Patients with pre-existing dermatological disease, autoimmune disease, malignancy or chemotherapy, pregnant or lactating women, blood transfusion, on immunosuppressant, malabsorption syndrome or taking any drug/vaccine within 14 days before onset of skin lesions will be excluded. Photographs of skin lesions will be taken by consent. DATA ANALYSIS: SPSS version 23 registered for Microsoft windows will be used for analysis. Mean and standard deviation will be calculated for expression of quantitative variables like age and disease duration of skin. Systemic symptoms duration, the latency between the systemic and cutaneous manifestations, and age for disease outcome will be calculated by median and interquartile range. Gender, co-morbidities, presence or absence of cutaneous/ systemic manifestations, cutaneous symptoms, skin patterns, time of onset of rash, and disease outcome covid-19 will be calculated by frequencies and percentages. Effect modifiers like age, gender, weight, co-morbidities, duration of symptoms will be controlled through stratification. Poststratification will be recalculated and chi-square test will be applied. P-value of <0.05% will be considered as significant.

Official Title
-----------------
Cutaneous Manifestations of Coronavirus Disease 2019(COVID-19).

Conditions
-----------------
Cutaneous Manifestations, Skin Manifestations, COVID-19, COVID-19 Pneumonia, COVID-19 Pandemic, Corona Virus Infection, Coronavirus Disease 2019, Sars-CoV-2 Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: both genders Any age PCR diagnosed COVID-19 patient irrespective of symptoms Exclusion Criteria: patient with diagnosed case of autoimmune disease on drugs known case of malignancy or chemotherapy recurrent transfusion history diagnosed case of malabsorption syndrome On immunosuppressant. Already having any prior skin disease Any drug/vaccine taken within 14 days before onset of rash Pregnant or lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of skin manifestations in 1206 | Frequency of skin manifestations in COVID-19 positive 1206 subjects. | From day of randomisation until development of skin manifestations or not, assessed upto 12 months | 
| COVID-19 Disease Outcome in patients with skin manifestations | Disease outcome of COVID-19 in participants who will be having cutanous manifestations and will be classified as mild moderate and severe. | Disease outcome during this 12 months duration of study. | 
| Cutaneous patterns | If present, type of skin manifestations to be noted | From day of randomisation until development of skin manifestations or not, assessed upto 12 months | 
| Association of COVID-19 disease outcome in correlation with skin manifestation | It is to check if presence of skin manifestations can affect COVID-19 disease outcome | From day of randomisation until development of skin manifestations or not, until COVID-19 disease outcome (improved, worsen or death) assessed upto 12 months | 
| Skin symptoms | If applicable, Skin symptoms as pruritis, burning or pain | From day of randomisation until development of skin manifestations or not, assessed upto 12 months | 
| Duration of skin manifestations | For how long the skin manifestations last before resolution or whether it persisted. | From day of randomisation until development of skin manifestation or not, if development/already developed skin manifestations then resolution of it or for how long it persisted, assessed upto 12 months | 
| The time of onset of skin manifestations | To check if skin manifestations can be an early sign of disease or a sole manifestation of COVID-19. (without, before, after or with systemic symptoms) | From day of randomisation until development of systemic manifestations or not, in patients with skin manifestations assessed upto 12 months | 
| Presence or absence of systemic symptoms in COVID-19 patients | To check if skin manifestations can be a sole presentation of COVID-19 | Day 1 of randomisation until development of systemic symptoms in patients with skin manifestations in upto 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency between the cutaneous manifestations and development of systemic symptoms of COVID-19 | To check if skin manifestations could be earlier symptom of COVID-19. | From day of randomisation until development of skin/systemic manifestations or not, assessed upto 12 months | 
| Duration of systemic symptoms | Duration of systemic symptoms till recovery or death | From day of randomisation to recovery or death, and also duration of symptoms prior to coming for consultation/hospital, assessed upto 12 months | 
| Type of systemic symptoms | To help categorising disease outcomes | From day of randomisation until development of systemic symptoms or not, assessed upto 12 months | 
| age of patients | to check which category of manifestation occurs more commonly at what age | Day 1 of randomisation until development of skin manifestations in upto 12 months | 
| comorbidities | to check their affect on disease outcome | Day 1 of randomisation until development of skin manifestations in upto 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, COVID-19 pneumonia, COVID-19 pandemic, Coronavirus disease 2019, Skin manifestations, Cutaneous manifestations, Cutaneous patterns, Livedo reticularis, Pseudo chilblains, Pernio-like lesion, Chilblains, Maculopapular rash, Scabies, Pityriasis rosea, Acral ischemia, Blue toe, Pustular, Papulopustular, Purpura fulminans, Urticaria, Erythema multiforme, Pruritis, Xerosis, Herpes zoster, Tinea, Papulosquamous, Vasculitis, Pityriasis versicolor, Aphthous ulcer, Oral candidiasis, Vesicular rash