PsoVac: Educational Needs re Vaccines for Biologic Patien... | NCT04513847

Studies
PsoVac: Educational Needs re Vaccines for Biologic Patients With Psoriasis

NCT04513847

Sponsor

Dermatrials Research

Status

Completed

Last Update Posted

Oct 8, 2020Actual

Enrollment

661Actual

Phase

Not provided

Conditions

Psoriasis
Covid19

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 13, 2020Actual

Primary Completion Date

Sep 13, 2020Actual

Completion Date

Oct 6, 2020Actual

First Submitted Date

Aug 12, 2020

First Submission Date that Met QC Criteria

Aug 13, 2020

First Posted Date

Aug 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2020

Last Update Posted Date

Oct 8, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ronald Vender MD FRCPC, Associate Clinical Professor, Division of Dermatology MD FRCPC, Dermatrials ResearchPrincipal Investigator

Lead Sponsor

Dermatrials ResearchOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. That will depend on the type of vaccine that becomes available.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

661Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control		Psoriasis patients treated with non-biologic
Non-Control		Psoriasis patients treated with biologic

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Data will be collected over a span of 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

psoriasis patient

Exclusion Criteria:

no exclusions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Dermatology Clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dermatrials Research		Hamilton	Ontario	L8N 1V6	Canada

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis
D000086382	COVID-19

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D011024	Pneumonia, Viral

Browse Leaves

Not provided

Browse Branches

Not provided