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临床试验/NCT04324866
NCT04324866Unknown不适用

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

Universita di Verona0 个研究点目标入组 300 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
主要终点
Point prevalence of COVID-19 infection

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Point prevalence of COVID-19 infection

时间窗: Baseline up to 6 months

次要结局

  • 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)

研究者

发起方
Universita di Verona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paolo Gisondi

Associate Professor

Universita di Verona

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