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

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

Detailed Description

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.

Unknown status
Coronavirus Infection

Diagnostic Test: Nasopharyngeal swab

Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Contacts

Paolo Gisondi
+39 0458122547
paolo.gisondi@univr.it

Azienda Ospedaliera Universitaria Integrata Verona
NCT Number
Keywords
psoriasis
immunosuppressant therapy
COVID 19
MeSH Terms
Infections
Communicable Diseases
COVID-19
Coronavirus Infections
Psoriasis