Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
Study NCT ID:
NCT04324866
Status:
UNKNOWN
Last Update Posted:
2020-03-27
First Post:
2020-03-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Nasopharyngeal swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-26', 'studyFirstSubmitDate': '2020-03-24', 'studyFirstSubmitQcDate': '2020-03-26', 'lastUpdatePostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Point prevalence of COVID-19 infection', 'timeFrame': 'Baseline up to 6 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of COVID-19 infection', 'timeFrame': 'Baseline up to 6 months'}, {'measure': 'Percentage of subjects presenting fever or respiratory symptoms', 'timeFrame': 'Baseline up to 6 months'}, {'measure': 'Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments', 'timeFrame': 'Baseline up to 6 months'}, {'measure': 'Evaluate the relationship between COVID-19 infection and comorbid medical conditions', 'timeFrame': 'Baseline up to 6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psoriasis', 'immunosuppressant therapy', 'covid 19'], 'conditions': ['Coronavirus Infection']}, 'descriptionModule': {'briefSummary': 'This study will assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressant therapy.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll patients from the Unit of Dermatology of Azienda Ospedaliera Universitaria di Verona and their partners.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Group 1\n\nInclusion Criteria:\n\n* Aged 18 to 75 years old\n* Individuals with a clinical diagnosis of moderate-to-severe chronic plaque psoriasis confirmed by the Investigator\n* Continuous immunosuppressive therapy (etanercept, adalimumab, infliximab, ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab, apremilast, methotrexate, ciclsoporin, acitretin) for the past 3 months\n* Is willing and able to sign informed consent to participate\n\nExclusion Criteria:\n\n* Patients unwilling to undergo noasopharyngeal swab\n* Inability to give informed consent\n\nGroup 2\n\nInclusion Criteria:\n\n* Aged 18 to 75 years old\n* Partner of a patient with psoriasis enrolled in the study\n* Is willing and able to sign informed consent to participate\n\nExclusion Criteria:\n\n* Personal history of psoriasis\n* Ongoing immunosuppressive therapy\n* Patients unwilling to undergo noasopharyngeal swab\n* Inability to give informed consent\n\nGroup 3\n\n* Aged 18 to 75 years old\n* Individuals with a clinical diagnosis of moderate-to-severe atopic dermatitis confirmed by the Investigator\n* Continuous therapy with dupilumab for the past 3 months\n* Is willing and able to sign informed consent to participate\n\nExclusion Criteria:\n\n* Patients unwilling to undergo noasopharyngeal swab\n* Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT04324866', 'briefTitle': 'Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Universita di Verona'}, 'officialTitle': 'Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy', 'orgStudyIdInfo': {'id': 'Gisondi 4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients with chronic plaque psoriasis on immunosuppressant therapy', 'interventionNames': ['Diagnostic Test: Nasopharyngeal swab']}, {'label': 'Group 2', 'description': "Psoriatic patients' partners", 'interventionNames': ['Diagnostic Test: Nasopharyngeal swab']}, {'label': 'Group 3', 'description': 'Patients with atopic dermatitis treated with dupilumab', 'interventionNames': ['Diagnostic Test: Nasopharyngeal swab']}], 'interventions': [{'name': 'Nasopharyngeal swab', 'type': 'DIAGNOSTIC_TEST', 'description': 'Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Paolo Gisondi', 'role': 'CONTACT', 'email': 'paolo.gisondi@univr.it', 'phone': '+39 0458122547'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universita di Verona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliera Universitaria Integrata Verona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Paolo Gisondi', 'investigatorAffiliation': 'Universita di Verona'}}}}