NCT05160428

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

1.6 years

First QC Date

December 14, 2021

Last Update Submit

January 9, 2023

Conditions

COVID-19Vaccination; InfectionRheumatic Diseases

Outcome Measures

Primary Outcomes (2)

  • -Prevalence of new ARD after covid-19 vaccinations

    any ARD

    3 moths

  • prevalence of flare of ARD after covid-19 vaccinations

    flare of any manifestations of the disease

    3 months

Secondary Outcomes (5)

  • Prevalence of non-specific MSK symptoms after Covid-19 vaccine.

    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.

    3 months

  • disease activity status in the patients who developed the ARD symptoms before and after the vaccine.

    3 months

  • Any correlation between the appearance of MSK symptoms and the patient's medications

    3 months

Interventions

COVID-19 vaccinationBIOLOGICAL

different types of covid-19 vaccinations.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy Hospital

Cairo, 15561, Egypt

RECRUITING

MeSH Terms

Conditions

COVID-19InfectionsRheumatic Diseases

Interventions

heterologous prime boost COVID-19 vaccination

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mohamed Abuzaid, MD

    Tanta University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mervat Eissa, MD

CONTACT

+201221738939metvateissa@kasralainy.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 14, 2021

First Posted

December 16, 2021

Study Start

February 1, 2022

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations

EG(1)