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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04324866
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Universita di Verona
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Coronavirus Infection
Additional Details

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.

Arms & Interventions

Arms

: Group 1

Patients with chronic plaque psoriasis on immunosuppressant therapy

: Group 2

Psoriatic patients' partners

: Group 3

Patients with atopic dermatitis treated with dupilumab

Interventions

Diagnostic Test: - Nasopharyngeal swab

Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Paolo Gisondi

paolo.gisondi@univr.it

+39 0458122547

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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