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| Name | Class |
|---|---|
| Azienda Ospedaliera Universitaria Integrata Verona | OTHER |
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This study will assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressant therapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Patients with chronic plaque psoriasis on immunosuppressant therapy |
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| Group 2 | Psoriatic patients' partners |
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| Group 3 | Patients with atopic dermatitis treated with dupilumab |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasopharyngeal swab | Diagnostic Test | Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Point prevalence of COVID-19 infection | Baseline up to 6 months |
| Measure | Description | 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 |
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Group 1
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Group 2
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Group 3
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This study will enroll patients from the Unit of Dermatology of Azienda Ospedaliera Universitaria di Verona and their partners.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paolo Gisondi | Contact | +39 0458122547 | paolo.gisondi@univr.it |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D011565 | Psoriasis |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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Nasopharyngeal swabs
| Baseline up to 6 months |
| Evaluate the relationship between COVID-19 infection and comorbid medical conditions | Baseline up to 6 months |
| D007239 |
| Infections |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |