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

Sponsor

Universita di Verona (Other)

Overall Status

Unknown status

CT.gov ID

NCT04324866

Collaborator

Azienda Ospedaliera Universitaria Integrata Verona (Other)

300

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infection	Diagnostic Test: Nasopharyngeal swab

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Nov 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Group 1

Patients with chronic plaque psoriasis on immunosuppressant therapy

Diagnostic Test: Nasopharyngeal swab

Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection

Group 2

Psoriatic patients' partners

Diagnostic Test: Nasopharyngeal swab

Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection

Group 3

Patients with atopic dermatitis treated with dupilumab

Diagnostic Test: Nasopharyngeal swab

Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection

Outcome Measures

Primary Outcome Measures

Point prevalence of COVID-19 infection [Baseline up to 6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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