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Completed

NCT Number: NCT05094687

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

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

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Key information

Conditions

Cutaneous Manifestations Bacterial Infections and Mycoses Blood Coagulation Disorders COVID-19 COVID-19 Pandemic COVID-19 Pneumonia Candidiasis Candidiasis, Oral Cardiovascular Diseases Chilblains Cold Injury Corona Virus Infection Coronaviridae Infections Coronavirus Disease 2019 Coronavirus Infections DNA Virus Infections Dermatomycoses Ectoparasitic Infestations Embolism and Thrombosis Erythema Erythema Multiforme Frostbite Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Herpes Zoster Herpesviridae Infections Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Livedo Reticularis Livedoid Vasculopathy Lung Diseases Mite Infestations Mouth Diseases Mycoses Nidovirales Infections Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Pityriasis Pityriasis Rosea Pneumonia Pneumonia, Viral Pruritus Purpura Purpura Fulminans RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV-2 Infection Scabies Signs and Symptoms Skin Diseases Skin Diseases, Infectious Skin Diseases, Papulosquamous Skin Diseases, Parasitic Skin Diseases, Vascular Skin Diseases, Vesiculobullous Skin Manifestations Skin and Connective Tissue Diseases Stomatitis Stomatitis, Aphthous Stomatognathic Diseases Thrombosis Tinea Tinea Versicolor Urticaria Varicella Zoster Virus Infection Vascular Diseases Vasculitis Virus Diseases Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jinnah Postgraduate Medical Centre

Karachi, Sindh, 75510, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Frequency of skin manifestations in 1206

    Time frame: From day of randomisation until development of skin manifestations or not, assessed upto 12 months

    Frequency of skin manifestations in COVID-19 positive 1206 subjects.

  2. COVID-19 Disease Outcome in patients with skin manifestations

    Time frame: Disease outcome during this 12 months duration of study.

    Disease outcome of COVID-19 in participants who will be having cutanous manifestations and will be classified as mild moderate and severe.

  3. Cutaneous patterns

    Time frame: From day of randomisation until development of skin manifestations or not, assessed upto 12 months

    If present, type of skin manifestations to be noted

  4. Association of COVID-19 disease outcome in correlation with skin manifestation

    Time frame: From day of randomisation until development of skin manifestations or not, until COVID-19 disease outcome (improved, worsen or death) assessed upto 12 months

    It is to check if presence of skin manifestations can affect COVID-19 disease outcome

  5. Skin symptoms

    Time frame: From day of randomisation until development of skin manifestations or not, assessed upto 12 months

    If applicable, Skin symptoms as pruritis, burning or pain

  6. Duration of skin manifestations

    Time frame: 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

    For how long the skin manifestations last before resolution or whether it persisted.

  7. The time of onset of skin manifestations

    Time frame: From day of randomisation until development of systemic manifestations or not, in patients with skin manifestations assessed upto 12 months

    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)

  8. Presence or absence of systemic symptoms in COVID-19 patients

    Time frame: Day 1 of randomisation until development of systemic symptoms in patients with skin manifestations in upto 12 months

    To check if skin manifestations can be a sole presentation of COVID-19

Secondary outcomes

  1. Latency between the cutaneous manifestations and development of systemic symptoms of COVID-19

    Time frame: From day of randomisation until development of skin/systemic manifestations or not, assessed upto 12 months

    To check if skin manifestations could be earlier symptom of COVID-19.

  2. Duration of systemic symptoms

    Time frame: From day of randomisation to recovery or death, and also duration of symptoms prior to coming for consultation/hospital, assessed upto 12 months

    Duration of systemic symptoms till recovery or death

  3. Type of systemic symptoms

    Time frame: From day of randomisation until development of systemic symptoms or not, assessed upto 12 months

    To help categorising disease outcomes

  4. age of patients

    Time frame: Day 1 of randomisation until development of skin manifestations in upto 12 months

    to check which category of manifestation occurs more commonly at what age

  5. comorbidities

    Time frame: Day 1 of randomisation until development of skin manifestations in upto 12 months

    to check their affect on disease outcome

Sponsors and collaborators

Lead sponsor

Jinnah Postgraduate Medical Centre

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 26, 2021
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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