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

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

Study Overview

• Status: Unknown
• Conditions: Coronavirus Infection
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Paolo Gisondi; Phone Number: +39 0458122547; Email: paolo.gisondi@univr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universita di Verona
• Collaborators: Azienda Ospedaliera Universitaria Integrata Verona

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2020
• Primary Completion (ANTICIPATED): November 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (ACTUAL): March 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: covid 19; psoriasis; immunosuppressant therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Skin Diseases, Papulosquamous; COVID-19; Coronavirus Infections; Infections; Communicable Diseases; Psoriasis
• Other Study ID Numbers: Gisondi 4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No