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 : Unknown
Verified March 2020 by Paolo Gisondi, Universita di Verona.
Recruitment status was: Not yet recruiting
First Posted : March 27, 2020
Last Update Posted : March 27, 2020
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Condition or disease | Intervention/treatment |
---|---|
Coronavirus Infection | Diagnostic Test: Nasopharyngeal swab |
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 |

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 |
- Point prevalence of COVID-19 infection [ Time Frame: Baseline up to 6 months ]
- 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 ]
Biospecimen Retention: Samples Without DNA

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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 |
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

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
Contact: Paolo Gisondi | +39 0458122547 | paolo.gisondi@univr.it |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
psoriasis immunosuppressant therapy covid 19 |
Infections Communicable Diseases COVID-19 Coronavirus Infections Psoriasis Disease Attributes Pathologic Processes Respiratory Tract Infections Pneumonia, Viral |
Pneumonia Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Skin Diseases, Papulosquamous Skin Diseases |