NCT04324866

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

March 24, 2020

Last Update Submit

March 26, 2020

Conditions

Keywords

psoriasisimmunosuppressant therapycovid 19

Outcome Measures

Primary Outcomes (1)

  • Point prevalence of COVID-19 infection

    Baseline up to 6 months

Secondary Outcomes (4)

  • 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

Study Arms (3)

Group 1

Patients with chronic plaque psoriasis on immunosuppressant therapy

Diagnostic Test: Nasopharyngeal swab

Group 2

Psoriatic patients' partners

Diagnostic Test: Nasopharyngeal swab

Group 3

Patients with atopic dermatitis treated with dupilumab

Diagnostic Test: Nasopharyngeal swab

Interventions

Nasopharyngeal swabDIAGNOSTIC_TEST

Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will enroll patients from the Unit of Dermatology of Azienda Ospedaliera Universitaria di Verona and their partners.

You may qualify if:

  • 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

You may not qualify if:

  • Patients unwilling to undergo noasopharyngeal swab
  • Inability to give informed consent
  • Group 2
  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal swabs

MeSH Terms

Conditions

Coronavirus InfectionsPsoriasisCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 27, 2020

Study Start

April 1, 2020

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

March 27, 2020

Record last verified: 2020-03