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

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ClinicalTrials.gov Identifier: NCT04324866
Recruitment Status : Not yet recruiting
First Posted : March 27, 2020
Last Update Posted : March 27, 2020
Sponsor:
Collaborator:
Azienda Ospedaliera Universitaria Integrata Verona
Information provided by (Responsible Party):
Paolo Gisondi, Universita di Verona

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

Condition or disease Intervention/treatment
Coronavirus Infection 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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Point prevalence of COVID-19 infection [ Time Frame: Baseline up to 6 months ]

Secondary Outcome Measures :
  1. Incidence of COVID-19 infection [ Time Frame: Baseline up to 6 months ]
  2. Percentage of subjects presenting fever or respiratory symptoms [ Time Frame: Baseline up to 6 months ]
  3. Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments [ Time Frame: Baseline up to 6 months ]
  4. Evaluate the relationship between COVID-19 infection and comorbid medical conditions [ Time Frame: Baseline up to 6 months ]

Biospecimen Retention:   Samples Without DNA
Nasopharyngeal swabs

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04324866


Contacts
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Contact: Paolo Gisondi +39 0458122547 paolo.gisondi@univr.it

Sponsors and Collaborators
Universita di Verona
Azienda Ospedaliera Universitaria Integrata Verona
More Information
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Responsible Party: Paolo Gisondi, Associate Professor, Universita di Verona
ClinicalTrials.gov Identifier: NCT04324866    
Other Study ID Numbers: Gisondi 4
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paolo Gisondi, Universita di Verona:
psoriasis
immunosuppressant therapy
covid 19
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Psoriasis
Skin Diseases, Papulosquamous
 Skin Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases