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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05094687
• Other study ID #: NO.F.2-81/2021-GEN/61595/JPMC
• Status: Completed
• Start date: July 31, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: November 2021
• Source: Jinnah Postgraduate Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1206
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Disease 2019
• Coronavirus Infections
• COVID-19
• COVID-19 Pandemic
• COVID-19 Pneumonia
• Infections
• Pneumonia
• Sars-CoV-2 Infection
• Skin Manifestations

Locations

Country	Name	City	State
Pakistan	Jinnah Postgraduate Medical Centre	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Jinnah Postgraduate Medical Centre

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Type of systemic symptoms	To help categorising disease outcomes	From day of randomisation until development of systemic symptoms or not, assessed upto 12 months
Secondary	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
Secondary	comorbidities	to check their affect on disease outcome	Day 1 of randomisation until development of skin manifestations in upto 12 months