NCT04702295

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

COVID Vaccination in Rare and Complex Connective Tissue Diseases: ERN ReCONNET Multicentre Prospective Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: University of Pisa · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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 1. To promote a harmonised data collection approach on COVID-19 vaccination in rare and complex CTDs patients; 2. To evaluate the safety profile of COVID-19 vaccination in rCTDs patients and to highlight possible disease-specific adverse events; 3. To evaluate the efficacy of COVID-19 vaccination in rCTDs patients and to highlight potential variables that prevent an effective immunization against COVID-19; 4. To evaluate differences in term of efficacy and safety among different types of vaccines in rCTDs patients 5. To depict the ideal patient's profile that would mostly benefit from COVID-19 vaccination

Conditions

• Connective Tissue Diseases
• Rare Diseases
• Rheumatologic Disorder

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-02-01
• Completion: 2023-08-01
• First posted: 2021-01-08
• Last updated: 2021-01-08