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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05160428
Other study ID # Post Covid Vaccination ARD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date October 2023

Study information

Verified date January 2023
Source Cairo University
Contact Mervat Eissa, MD
Phone +201221738939
Email metvateissa@kasralainy.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date October 2023
Est. primary completion date September 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Biological:
COVID-19 vaccination
different types of covid-19 vaccinations.

Locations

Country Name City State
Egypt Kasr Alainy Hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary -Prevalence of new ARD after covid-19 vaccinations any ARD 3 moths
Primary prevalence of flare of ARD after covid-19 vaccinations flare of any manifestations of the disease 3 months
Secondary Prevalence of non-specific MSK symptoms after Covid-19 vaccine. any MSK symptoms 3 months
Secondary Correlation of the MSK to the 1st and 2nd Covid vaccine dose Correlation of the MSK to the 1st and 2nd Covid vaccine dose 3 months
Secondary comparison between different type of covid-19 vaccine in inducing ARD or flare up. any type of flare 3 months
Secondary disease activity status in the patients who developed the ARD symptoms before and after the vaccine. activity assessed by disease activity scores 3 months
Secondary Any correlation between the appearance of MSK symptoms and the patient's medications current medications 3 months
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