ERN ReCONNET Study on COVID-19 Vaccination in Rare and Co... | NCT04702295

Studies
ERN ReCONNET Study on COVID-19 Vaccination in Rare and Complex Connective Tissue Disease (VACCINATE)

NCT04702295

Sponsor

University of Pisa

Status

Unknown status

Last Update Posted

Jan 8, 2021Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Connective Tissue Diseases
Rare Diseases
Rheumatologic Disorder

Interventions

Not provided

Countries

Not provided

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

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2021Estimated

Primary Completion Date

Feb 2023Estimated

Completion Date

Aug 2023Estimated

First Submitted Date

Jan 5, 2021

First Submission Date that Met QC Criteria

Jan 7, 2021

First Posted Date

Jan 8, 2021Actual

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

Jan 7, 2021

Last Update Posted Date

Jan 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

30 months, multicentre, prospective observational study on adult (>18 years) patients with a diagnosis of rare and complex connective tissue diseases (rCTDs) who will be given the vaccine during the period from January 2021 and January 2022.

Patients with the following diagnosis will be included:

antiphospholipid syndrome (APS),
Ehlers-Danlos syndrome (EDS),
idiopathic inflammatory myopathies (IIM),
IgG4-related disease (IgG4),
mixed connective tissue disease (MCTD),
relapsing polychondritis (RP),
Sjogren's syndrome (SS),
systemic lupus erythematosus (SLE),
systemic sclerosis (SSc)
undifferentiated connective tissue disease (UCTD)

Detailed Description

This is an observational study aimed at gathering sufficient number of cases of rCTDs patients who will receive COVID-19 vaccination that will help in better understanding of both safety and efficacy of the vaccine in this population. The study will be promoted both in ERN ReCONNET Full Members and Affiliated Partners as well as in other centres treating and managing rare and complex connective tissue diseases.

Study Objectives

To promote a harmonised data collection approach on COVID-19 vaccination in rare and complex CTDs patients;
To evaluate the safety profile of COVID-19 vaccination in rCTDs patients and to highlight possible disease-specific adverse events;
To evaluate the efficacy of COVID-19 vaccination in rCTDs patients and to highlight potential variables that prevent an effective immunization against COVID-19;
To evaluate differences in term of efficacy and safety among different types of vaccines in rCTDs patients
To depict the ideal patient's profile that would mostly benefit from COVID-19 vaccination

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

250Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse events (any type)		12 months
COVID-19 incidence in patients with and without evidence of past SARS-CoV-2 infection before and during vaccination regimen - cases confirmed ≥7 days after the last dose		12 months

Secondary Outcomes

Measure	Description	Time Frame
Incidence of disease flare post-vaccination		12 months
Incidence of serious adverse events		12 months
Incidence of life-threatening adverse events and deaths

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with the following diagnosis will be included:

antiphospholipid syndrome (APS),
Ehlers-Danlos syndrome (EDS),
idiopathic inflammatory myopathies (IIM),
IgG4-related disease (IgG4),
mixed connective tissue disease (MCTD),
relapsing polychondritis (RP),
Sjogren's syndrome (SS),
systemic lupus erythematosus (SLE),
systemic sclerosis (SSc)
undifferentiated connective tissue disease (UCTD)

Exclusion Criteria:

Pregnancy
All the exclusion criteria that apply for COVID-19 vaccination in the general population

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

adult (>18 years) patients with a diagnosis of rCTDs who will be given the vaccine during the period from January 2021 and January 2022.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D003240	Connective Tissue Diseases
D035583	Rare Diseases
D003095	Collagen Diseases

Ancestor Terms

ID	Term
D017437	Skin and Connective Tissue Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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