Clinical trial NCT05094687: Cutaneous Manifestations of Coronavirus Disease 2019(COVID-19).
Official title: Cutaneous Manifestations of Coronavirus Disease 2019(COVID-19).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Manifestations
Skin Manifestations
COVID-19
COVID-19 Pneumonia
COVID-19 Pandemic
Corona Virus Infection
Coronavirus Disease 2019
Sars-CoV-2 Infection
Keywords: 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
Lead sponsor: Jinnah Postgraduate Medical Centre
Sponsor class: OTHER_GOV
First posted: 2021-10-26
Enrollment: 1206
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1206 patients diagnosed case of COVID-19 by PCR.

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.

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.

Primary outcomes:
measure: Frequency of skin manifestations in 1206
timeFrame: From day of randomisation until development of skin manifestations or not, assessed upto 12 months
measure: COVID-19 Disease Outcome in patients with skin manifestations
timeFrame: Disease outcome during this 12 months duration of study.
measure: Cutaneous patterns
timeFrame: From day of randomisation until development of skin manifestations or not, assessed upto 12 months
measure: Association of COVID-19 disease outcome in correlation with skin manifestation
timeFrame: From day of randomisation until development of skin manifestations or not, until COVID-19 disease outcome (improved, worsen or death) assessed upto 12 months
measure: Skin symptoms
timeFrame: From day of randomisation until development of skin manifestations or not, assessed upto 12 months
measure: Duration of skin manifestations
timeFrame: 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
measure: The time of onset of skin manifestations
timeFrame: From day of randomisation until development of systemic manifestations or not, in patients with skin manifestations assessed upto 12 months
measure: Presence or absence of systemic symptoms in COVID-19 patients
timeFrame: Day 1 of randomisation until development of systemic symptoms in patients with skin manifestations in upto 12 months
Secondary outcomes:
measure: Latency between the cutaneous manifestations and development of systemic symptoms of COVID-19
timeFrame: From day of randomisation until development of skin/systemic manifestations or not, assessed upto 12 months
measure: Duration of systemic symptoms
timeFrame: From day of randomisation to recovery or death, and also duration of symptoms prior to coming for consultation/hospital, assessed upto 12 months
measure: Type of systemic symptoms
timeFrame: From day of randomisation until development of systemic symptoms or not, assessed upto 12 months
measure: age of patients
timeFrame: Day 1 of randomisation until development of skin manifestations in upto 12 months
measure: comorbidities
timeFrame: Day 1 of randomisation until development of skin manifestations in upto 12 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Jinnah Postgraduate Medical Centre
state: Sindh
Study officials:
affiliation: Jinnah Postgraduate Medical Centre
name: Rabia Ghafoor, MBBS, FCPS, SCE-Derm(MRCP-UK)
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinnah Postgraduate Medical Centre
name: Syeda Mahanum Ali, MBBS, Postgraduate Trainee
role: PRINCIPAL_INVESTIGATOR
References: