Post Covid-19 Vaccination Development or Flare of ARD

COVID-19 Clinical Trial

— PoCov-ARD  

Official title:

New or Flare of Musculoskeletal Rheumatic Diseases After Different COVID-19 Vaccines: Multicentre Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05160428
• Other study ID #: Post Covid Vaccination ARD
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Collagen Diseases
• COVID-19
• Rheumatic Diseases
• Vaccination; Infection

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