Coronavirus InfectionNCT04324866
Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy
An observational study of Coronavirus Infection, run by Universita di Verona.
Trial summary
This study will assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressant therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- Nasopharyngeal swab
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll patients from the Unit of Dermatology of Azienda Ospedaliera Universitaria di Verona and their partners.
Who may be able to join
- 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
- 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
Who cannot join
- Patients unwilling to undergo noasopharyngeal swab
- Inability to give informed consent
- Group 2
- Personal history of psoriasis
- Ongoing immunosuppressive therapy
- Patients unwilling to undergo noasopharyngeal swab
Show all 14Show fewer
- 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
- Patients unwilling to undergo noasopharyngeal swab
- Inability to give informed consent
Trial locations and contacts
No sites are listed yet.
About this study
This study will assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressant therapy.
Read the 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.
- Conditions
- Coronavirus Infection
- Being tested
- Nasopharyngeal swab
- Keywords
- psoriasis, immunosuppressant therapy, covid 19
- Medical subject headings
- Coronavirus Infections, Psoriasis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal swabDiagnostic test
Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with chronic plaque psoriasis on immunosuppressant therapy Receives: Diagnostic Test: Nasopharyngeal swab | |
| Group 2 | Psoriatic patients' partners Receives: Diagnostic Test: Nasopharyngeal swab | |
| Group 3 | Patients with atopic dermatitis treated with dupilumab Receives: Diagnostic Test: Nasopharyngeal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point prevalence of COVID-19 infection
Measured: Baseline up to 6 months
Secondary outcomes (4)
Incidence of COVID-19 infection
Measured: Baseline up to 6 months
Percentage of subjects presenting fever or respiratory symptoms
Measured: Baseline up to 6 months
Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments
Measured: Baseline up to 6 months
Evaluate the relationship between COVID-19 infection and comorbid medical conditions
Measured: Baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona
- Responsible party
- Principal investigator, Paolo Gisondi, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324866
- Sponsor's protocol ID
- Gisondi 4
- Status last verified
- Mar 2020
- First submitted
- 24 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy
- ClinicalTrials.gov ID
- NCT04324866
- Acronym / sponsor ID
- Gisondi 4
- Conditions
- Coronavirus Infection
- Keywords
- psoriasis, immunosuppressant therapy, covid 19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Nasopharyngeal swabPatients with chronic plaque psoriasis on immunosuppressant therapy |
| Group 2 | – | Diagnostic Test: Nasopharyngeal swabPsoriatic patients' partners |
| Group 3 | – | Diagnostic Test: Nasopharyngeal swabPatients with atopic dermatitis treated with dupilumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll patients from the Unit of Dermatology of Azienda Ospedaliera Universitaria di Verona and their partners.
Key inclusion criteria (7 listed)
- 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
- Aged 18 to 75 years old
Key exclusion criteria (14 listed)
- Patients unwilling to undergo noasopharyngeal swab
- Inability to give informed consent
- Group 2
- Personal history of psoriasis
- Ongoing immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopharyngeal swabNasopharyngeal swab for the molecular diagnosis of COVID-19 infection | Diagnostic test | Group 1, Group 2, Group 3 |
Primary outcome
Point prevalence of COVID-19 infection
Time frame: Baseline up to 6 months
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infection, run by Universita di Verona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Gisondi (+39 0458122547, paolo.gisondi@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point prevalence of COVID-19 infection (time frame: Baseline up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.