PsoriasisNCT04513847
PsoVac: Educational Needs re Vaccines for Biologic Patients With Psoriasis
An observational study of Psoriasis and Covid19, run by Dermatrials Research at 1 site in Canada.
Trial summary
To determine if there is a need for further education on vaccines with psoriasis patients who are on a biologic. In regards to the COVID-19, it is important that psoriasis patients - whether on a biologic or not - understand whether they can have certain vaccines. Read more about this study
- Who is it for?
- Any age
- How many people
- 661 participants
- Where
- 1 siteCanada
- Study dates
- 13 Aug 2020to 6 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Dermatology Clinic
Who may be able to join
- psoriasis patient
Who cannot join
- no exclusions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PsoVac: A Psoriatic Patient-based Survey on the Understanding of the Use of Vaccines While on Biologics During the Covid-19 Pandemic
To determine if there is a need for further education on vaccines with psoriasis patients who are on a biologic. In regards to the COVID-19, it is important that psoriasis patients - whether on a biologic or not - understand whether they can have certain vaccines. That will depend on the type of vaccine that becomes available.
- Keywords
- Education, Vaccine, Biologic
- Medical subject headings
- Psoriasis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Psoriasis patients treated with non-biologic | |
| Non-Control | Psoriasis patients treated with biologic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients not understanding the interaction of vaccines and their biologic, assessed with voluntary survey.
Assessment is based upon survey responses. By answering multiple questions we will determine if more education is needed based on the answers.
Measured: Data will be collected over a span of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start13 Aug 2020
- Primary completion13 Sep 2020
- Study completion6 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 661 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermatrials Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Vender MD FRCPC, Dermatrials Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513847
- Sponsor's protocol ID
- Pso-Vac
- Status last verified
- Oct 2020
- First submitted
- 12 Aug 2020
- Last updated
- 8 Oct 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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PsoVac: A Psoriatic Patient-based Survey on the Understanding of the Use of Vaccines While on Biologics During the Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT04513847
- Acronym / sponsor ID
- Pso-Vac
- Keywords
- Education, Vaccine, Biologic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 661 participants (actual)
- Lead sponsor
- Dermatrials ResearchUniversity, hospital or other
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 13 Sep 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 14 Aug 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.
To determine if there is a need for further education on vaccines with psoriasis patients who are on a biologic. In regards to the COVID-19, it is important that psoriasis patients - whether on a biologic or not - understand whether they can have certain vaccines. That will depend on the type of vaccine that becomes available.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Psoriasis patients treated with non-biologic |
| Non-Control | – | –Psoriasis patients treated with biologic |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Dermatology Clinic
Key inclusion criteria (1 listed)
- psoriasis patient
Key exclusion criteria (1 listed)
- no exclusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients not understanding the interaction of vaccines and their biologic, assessed with voluntary survey.
Time frame: Data will be collected over a span of 3 months
Assessment is based upon survey responses. By answering multiple questions we will determine if more education is needed based on the answers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Covid19, run by Dermatrials Research at 1 site in Canada.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients not understanding the interaction of vaccines and their biologic, assessed with voluntary survey. (time frame: Data will be collected over a span of 3 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 8 Oct 2020.