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

Coronavirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04324866
• Other study ID #: Gisondi 4
• Status: Not yet recruiting
• Start date: April 1, 2020
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Universita di Verona
• Contact: Paolo Gisondi
• Phone: +39 0458122547
• Email: paolo.gisondi[@]univr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infection
• Coronavirus Infections
• Infection
• Psoriasis
• Severe Acute Respiratory Syndrome

Intervention

Diagnostic Test:
• Nasopharyngeal swab
Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universita di Verona	Azienda Ospedaliera Universitaria Integrata Verona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point prevalence of COVID-19 infection		Baseline up to 6 months
Secondary	Incidence of COVID-19 infection		Baseline up to 6 months
Secondary	Percentage of subjects presenting fever or respiratory symptoms		Baseline up to 6 months
Secondary	Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments		Baseline up to 6 months
Secondary	Evaluate the relationship between COVID-19 infection and comorbid medical conditions		Baseline up to 6 months