Coronavirus Infection
Conditions
Keywords
psoriasis, immunosuppressant therapy, covid 19
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.
Interventions
DIAGNOSTIC_TESTNasopharyngeal swab
Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Universita di Verona
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Point prevalence of COVID-19 infection | Baseline up to 6 months |
Secondary
| 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 |
Contacts
Primary ContactPaolo Gisondi
Outcome results
None listed