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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

Tracking Information
First Submitted Date March 24, 2020
First Posted Date March 27, 2020
Last Update Posted Date March 27, 2020
Estimated Study Start Date April 1, 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 26, 2020)
Point prevalence of COVID-19 infection [ Time Frame: Baseline up to 6 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 26, 2020)
  • Incidence of COVID-19 infection [ Time Frame: Baseline up to 6 months ]
  • Percentage of subjects presenting fever or respiratory symptoms [ Time Frame: Baseline up to 6 months ]
  • Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments [ Time Frame: Baseline up to 6 months ]
  • Evaluate the relationship between COVID-19 infection and comorbid medical conditions [ Time Frame: Baseline up to 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy
Official Title Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Nasopharyngeal swabs
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.
Condition Coronavirus Infection
Intervention Diagnostic Test: Nasopharyngeal swab
Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection
Study Groups/Cohorts
  • Group 1
    Patients with chronic plaque psoriasis on immunosuppressant therapy
    Intervention: Diagnostic Test: Nasopharyngeal swab
  • Group 2
    Psoriatic patients' partners
    Intervention: Diagnostic Test: Nasopharyngeal swab
  • Group 3
    Patients with atopic dermatitis treated with dupilumab
    Intervention: Diagnostic Test: Nasopharyngeal swab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: March 26, 2020)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Paolo Gisondi +39 0458122547 paolo.gisondi@univr.it
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04324866
Other Study ID Numbers Gisondi 4
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Paolo Gisondi, Universita di Verona
Study Sponsor Universita di Verona
Collaborators Azienda Ospedaliera Universitaria Integrata Verona
Investigators Not Provided
PRS Account Universita di Verona
Verification Date March 2020