Post Covid-19 Vaccination Development or Flare of ARD

Recruiting

• Conditions: COVID-19; Rheumatic Diseases; Vaccination; Infection

• Registration Number: NCT05160428
• Lead Sponsor: Cairo University

Brief Summary

Many patients develop autoimmune diseases after covid-19 vaccination, whether related to the vaccination or not, is still under study. This study will describe potential flare of ARD after COVID-19 vaccination, whether it leads to activity or new MSK manifestations development.

Detailed Description

-In this study: patients with known diagnosed rheumatic diseases who are vaccinated (one or full doses) of any type of COVID-19 vaccines will be enrolled. new ARD and prevalence of different MSK manifestations after covid-19 vaccinations also will be reported. The prevalence of flare of ARD after covid-19 vaccinations will be dteremined. Also we will compare between different types and doses of covid-19 vaccinations in inducing ARD or flares.

Study Design: Cross sectional study Target population: any patient with pre-existing received any vaccination against covid-19 visiting rheumatology outpatient clinic.

-any patient develops MSK manifestations after covid-19 vaccination. The disease activity sataus will be measured according to the type of rheumatic disease. For RA , disease activity score28 will be used, in lupus: SLEDAI, in Behcet : BDCAF, in SpA: BASDAI.

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2021-12-16
• Study Start: 2022-02-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-11
• Primary Completion: 2023-09
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Age above 18 years Vaccinated against covid-19 (one dose or fully vaccinated)

Exclusion Criteria

Receiving other vaccine e.g influenza Less than 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalence of flare of ARD after covid-19 vaccinations	3 months	flare of any manifestations of the disease
-Prevalence of new ARD after covid-19 vaccinations	3 moths	any ARD

Secondary Outcome Measures

Name	Time	Method
Prevalence of non-specific MSK symptoms after Covid-19 vaccine.	3 months	any MSK symptoms
Correlation of the MSK to the 1st and 2nd Covid vaccine dose	3 months	Correlation of the MSK to the 1st and 2nd Covid vaccine dose
disease activity status in the patients who developed the ARD symptoms before and after the vaccine.	3 months	activity assessed by disease activity scores
Any correlation between the appearance of MSK symptoms and the patient's medications	3 months	current medications
comparison between different type of covid-19 vaccine in inducing ARD or flare up.	3 months	any type of flare

Trial Locations

Locations (1)

Kasr Alainy Hospital; 🇪🇬 Cairo, Egypt