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

NCT ID: NCT05094687

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-31

Study Completion Date

2021-08-01

Brief Summary

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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

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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.

Conditions

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

Keywords

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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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jinnah Postgraduate Medical Centre

OTHER_GOV

Sponsor Role lead

Responsible Party

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Rabia Ghafoor

Rabia ghafoor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rabia Ghafoor, MBBS, FCPS, SCE-Derm(MRCP-UK)

Role: PRINCIPAL_INVESTIGATOR

Jinnah Postgraduate Medical Centre

Syeda Mahanum Ali, MBBS, Postgraduate Trainee

Role: PRINCIPAL_INVESTIGATOR

Jinnah Postgraduate Medical Centre

Locations

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Jinnah Postgraduate Medical Centre

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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NO.F.2-81/2021-GEN/61595/JPMC

Identifier Type: -

Identifier Source: org_study_id