Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy

Study Overview
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Brief Summary
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This study will assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressant therapy.

Detailed Description
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The ongoing COVID-19 pandemic has hit Northern Italy (including the Veneto region) particularly hard, causing several deaths and putting a huge strain on the Italian National Healthcare System. In the absence of specific treatments, preventing the infection from spreading remains the only effective measure. There is a lot of apprehension both from doctors (including dermatologists, rheumatologists and gastroenterologists) and their patients that immunosuppressive medications (biologics, methotrexate, ciclosporin and corticosteroids) might lead to an increased susceptibility to COVID-19 infection or negatively influence the course of the infection. However, there is currently a lack of scientific evidence to recommend whether immunosuppressive treatments should or should not be continued in patients who have no symptoms of COVID-19 infection. Besides, treatment discontinuation would cause flare-ups of diseases - such as plaque psoriasis, psoriatic arthritis and inflammatory bowel diseases - which are invalidating and have a relatively high prevalence in the Veneto population. In the Unit of Dermatology of the Azienda Ospedaliera Universitaria Intergrata di Verona alone, more than 2000 patients are currently being treated with immunosuppressive agents. As of now, there are no data available on the prevalence and incidence of COVID-19 infection in patients with immune-mediated diseases, nor can data from randomized clinical trials be extrapolated to the susceptibility to COVID-19 infection in patients on biologic drugs. This study aims to assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressive therapy and to identify associated risk factors. Such data would prove invaluable for clinicians dealing with patients on immunosuppressive agents during the coronavirus outbreak.

Official Title
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Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy

Conditions
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Coronavirus Infection

Intervention / Treatment
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* Diagnostic Test: Nasopharyngeal swab


Participation Criteria
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Eligibility Criteria
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Group 1 Inclusion Criteria: Aged 18 to 75 years old Individuals with a clinical diagnosis of moderate-to-severe chronic plaque psoriasis confirmed by the Investigator Continuous immunosuppressive therapy (etanercept, adalimumab, infliximab, ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab, apremilast, methotrexate, ciclsoporin, acitretin) for the past 3 months Is willing and able to sign informed consent to participate Exclusion Criteria: Patients unwilling to undergo noasopharyngeal swab Inability to give informed consent Group 2 Inclusion Criteria: Aged 18 to 75 years old Partner of a patient with psoriasis enrolled in the study Is willing and able to sign informed consent to participate Exclusion Criteria: Personal history of psoriasis Ongoing immunosuppressive therapy Patients unwilling to undergo noasopharyngeal swab Inability to give informed consent Group 3 Aged 18 to 75 years old Individuals with a clinical diagnosis of moderate-to-severe atopic dermatitis confirmed by the Investigator Continuous therapy with dupilumab for the past 3 months Is willing and able to sign informed consent to participate Exclusion Criteria: Patients unwilling to undergo noasopharyngeal swab Inability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients with chronic plaque psoriasis on immunosuppressant therapy | Diagnostic Test: Nasopharyngeal swab<br>* Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection<br>|
| Group 2<br>Psoriatic patients' partners | Diagnostic Test: Nasopharyngeal swab<br>* Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection<br>|
| Group 3<br>Patients with atopic dermatitis treated with dupilumab | Diagnostic Test: Nasopharyngeal swab<br>* Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point prevalence of COVID-19 infection |  | Baseline up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of COVID-19 infection |  | Baseline up to 6 months | 
| Percentage of subjects presenting fever or respiratory symptoms |  | Baseline up to 6 months | 
| Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments |  | Baseline up to 6 months | 
| Evaluate the relationship between COVID-19 infection and comorbid medical conditions |  | Baseline up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, immunosuppressant therapy, covid 19