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临床试验/NCT05094687
NCT05094687已完成不适用

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

Jinnah Postgraduate Medical Centre1 个研究点 分布在 1 个国家目标入组 1,206 人开始时间: 2020年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,206
试验地点
1
主要终点
Frequency of skin manifestations in 1206

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • both genders Any age PCR diagnosed COVID-19 patient irrespective of symptoms

排除标准

  • 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.

结局指标

主要结局

Frequency of skin manifestations in 1206

时间窗: 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.

COVID-19 Disease Outcome in patients with skin manifestations

时间窗: 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.

The time of onset of skin manifestations

时间窗: 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)

Cutaneous patterns

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

If present, type of skin manifestations to be noted

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

时间窗: 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

Skin symptoms

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

If applicable, Skin symptoms as pruritis, burning or pain

Duration of skin manifestations

时间窗: 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.

Presence or absence of systemic symptoms in COVID-19 patients

时间窗: 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

次要结局

  • Type of systemic symptoms(From day of randomisation until development of systemic symptoms or not, assessed upto 12 months)
  • Duration of systemic symptoms(From day of randomisation to recovery or death, and also duration of symptoms prior to coming for consultation/hospital, assessed upto 12 months)
  • Latency between the cutaneous manifestations and development of systemic symptoms of COVID-19(From day of randomisation until development of skin/systemic manifestations or not, assessed upto 12 months)
  • age of patients(Day 1 of randomisation until development of skin manifestations in upto 12 months)
  • comorbidities(Day 1 of randomisation until development of skin manifestations in upto 12 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Rabia Ghafoor

Rabia ghafoor

Jinnah Postgraduate Medical Centre

研究点 (1)

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