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

NCT ID: NCT04324866

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2020-12-31

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.

Conditions

Coronavirus Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Patients with chronic plaque psoriasis on immunosuppressant therapy

Nasopharyngeal swab

Intervention Type: DIAGNOSTIC_TEST

Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection

Group 2

Psoriatic patients' partners

Nasopharyngeal swab

Intervention Type: DIAGNOSTIC_TEST

Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection

Group 3

Patients with atopic dermatitis treated with dupilumab

Nasopharyngeal swab

Intervention Type: DIAGNOSTIC_TEST

Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection

Interventions

Nasopharyngeal swab

Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• 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

• Patients unwilling to undergo noasopharyngeal swab
• Inability to give informed consent

Group 2

• 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

• Patients unwilling to undergo noasopharyngeal swab
• Inability to give informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: collaborator

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Paolo Gisondi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Paolo Gisondi

Role: CONTACT

paolo.gisondi@univr.it

+39 0458122547

Other Identifiers

Gisondi 4

Identifier Type: -

Identifier Source: org_study_id