Post Covid-19 Vaccination Development or Flare of ARD (PoCov-ARD)

January 9, 2023 updated by: Mervat Eissa, Cairo University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 15561
        • Recruiting
        • Kasr Alainy Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Eligibility Criteria:

Patients above 18 years old having MRD manifestations vaccinated against covid-19.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
-Prevalence of new ARD after covid-19 vaccinations
Time Frame: 3 moths
any ARD
3 moths
prevalence of flare of ARD after covid-19 vaccinations
Time Frame: 3 months
flare of any manifestations of the disease
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mohamed Abuzaid, MD, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

December 16, 2021

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Post Covid Vaccination ARD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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