Clinical trial NCT04324866: Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy
Official title: Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Infection
Keywords: psoriasis
immunosuppressant therapy
covid 19
Lead sponsor: Universita di Verona
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Universitaria Integrata Verona
First posted: 2020-03-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll patients from the Unit of Dermatology of Azienda Ospedaliera Universitaria di Verona and their partners.

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.

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

Primary outcomes:
measure: Point prevalence of COVID-19 infection
timeFrame: Baseline up to 6 months
Secondary outcomes:
measure: Incidence of COVID-19 infection
timeFrame: Baseline up to 6 months
measure: Percentage of subjects presenting fever or respiratory symptoms
timeFrame: Baseline up to 6 months
measure: Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments
timeFrame: Baseline up to 6 months
measure: Evaluate the relationship between COVID-19 infection and comorbid medical conditions
timeFrame: Baseline up to 6 months
Other outcomes:
Locations:
Study officials:
References: