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PoCov-ARD: Post Covid-19 Vaccination Development or Flare of ARD

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05160428
Collaborator
(none)
500
Enrollment
1
Location
7.9
Anticipated Duration (Months)
63.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: COVID-19 vaccination

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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
New or Flare of Musculoskeletal Rheumatic Diseases After Different COVID-19 Vaccines: Multicentre Study
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Outcome Measures

Primary Outcome Measures

  1. -Prevalence of new ARD after covid-19 vaccinations [3 moths]

    any ARD

  2. prevalence of flare of ARD after covid-19 vaccinations [3 months]

    flare of any manifestations of the disease

Secondary Outcome Measures

  1. Prevalence of non-specific MSK symptoms after Covid-19 vaccine. [3 months]

    any MSK symptoms

  2. 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

  3. comparison between different type of covid-19 vaccine in inducing ARD or flare up. [3 months]

    any type of flare

  4. disease activity status in the patients who developed the ARD symptoms before and after the vaccine. [3 months]

    activity assessed by disease activity scores

  5. Any correlation between the appearance of MSK symptoms and the patient's medications [3 months]

    current medications

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kasr Alainy Hospital Cairo Egypt 15561

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Mohamed Abuzaid, MD, Tanta University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mervat Eissa, Associate Professor, Cairo University
ClinicalTrials.gov Identifier:
NCT05160428
Other Study ID Numbers:
  • Post Covid Vaccination ARD
First Posted:
Dec 16, 2021
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19
Rheumatic Diseases
Collagen Diseases

Study Results

No Results Posted as of Jul 20, 2022