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

NCT05094687 | Completed DMC

• 1 other identifier: NO.F.2-81/2021-GEN/61595/JPMC
• Study Type: observational
• Target: 1,206
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

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; Erythema multiforme; Pruritis; Xerosis; Herpes zoster; Tinea; Papulosquamous; Vasculitis; Pityriasis versicolor; Aphthous ulcer; Oral candidiasis; Vesicular rash

Outcome Measures

Primary Outcomes (8)

• 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

• 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.

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• 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

• 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

• Type of systemic symptoms

  From day of randomisation until development of systemic symptoms 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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1206 patients diagnosed case of COVID-19 by PCR.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Study Sites (1)

Jinnah Postgraduate Medical Centre

Karachi, Sindh, 75510, Pakistan

Location

MeSH Terms

Conditions

Skin Manifestations; COVID-19; Coronavirus Infections; Livedo Reticularis; Chilblains; Scabies; Pityriasis Rosea; Purpura Fulminans; Urticaria; Erythema Multiforme; Pruritus; Herpes Zoster; Tinea; Vasculitis; Tinea Versicolor; Stomatitis, Aphthous; Candidiasis, Oral

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Frostbite; Cold Injury; Wounds and Injuries; Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Skin Diseases, Infectious; Pityriasis; Skin Diseases, Papulosquamous; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Erythema; Skin Diseases, Vesiculobullous; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Stomatitis; Mouth Diseases; Stomatognathic Diseases; Candidiasis

Study Officials

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

  Jinnah Postgraduate Medical Centre

  PRINCIPAL INVESTIGATOR

• Syeda Mahanum Ali, MBBS, Postgraduate Trainee

  Jinnah Postgraduate Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rabia ghafoor

Study Record Dates

• First Submitted: October 23, 2021
• First Posted: October 26, 2021
• Study Start: July 31, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: November 22, 2021

Record last verified: 2021-11

Locations

PA (1)