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AzTrials

Cutaneous ManifestationsNCT05094687

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

An observational study of Cutaneous Manifestations and Skin Manifestations, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
How many people
1,206 participants
Where
1 sitePakistan
Study dates
31 Jul 2020to 1 Aug 2021
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 1206 patients diagnosed case of COVID-19 by PCR.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Jinnah Postgraduate Medical Centre

    Karachi, Sindh, 75510

Other trials in Pakistan

About this study

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

Read the 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.

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
Medical subject headings
Skin Manifestations, COVID-19, Coronavirus Infections, Livedo Reticularis, Chilblains, Scabies, Pityriasis Rosea, Purpura Fulminans

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of skin manifestations in 1206

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

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

  2. 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.

    Measured: Disease outcome during this 12 months duration of study.

  3. Cutaneous patterns

    If present, type of skin manifestations to be noted

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

  4. 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

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

  5. Skin symptoms

    If applicable, Skin symptoms as pruritis, burning or pain

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

  6. Duration of skin manifestations

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

    Measured: 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

  7. 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)

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

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

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

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

Secondary outcomes (5)

  1. 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.

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

  2. Duration of systemic symptoms

    Duration of systemic symptoms till recovery or death

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

  3. Type of systemic symptoms

    To help categorising disease outcomes

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

  4. age of patients

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

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

  5. comorbidities

    to check their affect on disease outcome

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2021
  2. Study start31 Jul 2020
  3. Primary completion1 Aug 2021
  4. Study completion1 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
1,206 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05094687
Sponsor's protocol ID
NO.F.2-81/2021-GEN/61595/JPMC
Status last verified
Nov 2021
First submitted
23 Oct 2021
Last updated
22 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cutaneous Manifestations and Skin Manifestations, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of skin manifestations in 1206 (time frame: From day of randomisation until development of skin manifestations or not, assessed upto 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05094687.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.

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