COVID-19PoCov-ARDNCT05160428
Post Covid-19 Vaccination Development or Flare of ARD
An observational study of COVID-19 and Vaccination; Infection, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Vaccination; Infection, Rheumatic Diseases
- What is being tested?
- COVID-19 vaccination
- Type of treatment
- Vaccines
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Eligibility Criteria: Patients above 18 years old having MRD manifestations vaccinated against covid-19.
Who may be able to join
- Age above 18 years Vaccinated against covid-19 (one dose or fully vaccinated)
Who cannot join
- Receiving other vaccine e.g influenza Less than 18 years old
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy Hospital
Cairo, 15561
Mervat Eissa, MD, +201221738939, mervat.eissa@cu.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Vaccination; Infection, Rheumatic Diseases
- Being tested
- COVID-19 vaccination
- Medical subject headings
- COVID-19, Infections, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccinationBiological
different types of covid-19 vaccinations.
What is being measured
The primary outcome is the main question the study is designed to answer.
-Prevalence of new ARD after covid-19 vaccinations
any ARD
Measured: 3 moths
prevalence of flare of ARD after covid-19 vaccinations
flare of any manifestations of the disease
Measured: 3 months
Secondary outcomes (5)
Prevalence of non-specific MSK symptoms after Covid-19 vaccine.
any MSK symptoms
Measured: 3 months
Correlation of the MSK to the 1st and 2nd Covid vaccine dose
Correlation of the MSK to the 1st and 2nd Covid vaccine dose
Measured: 3 months
comparison between different type of covid-19 vaccine in inducing ARD or flare up.
any type of flare
Measured: 3 months
disease activity status in the patients who developed the ARD symptoms before and after the vaccine.
activity assessed by disease activity scores
Measured: 3 months
Any correlation between the appearance of MSK symptoms and the patient's medications
current medications
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start1 Feb 2022
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mervat Eissa, Cairo University
- Investigators
- Mohamed Abuzaid, MD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160428
- Sponsor's protocol ID
- Post Covid Vaccination ARD
- Acronym
- PoCov-ARD
- Status last verified
- Jan 2023
- First submitted
- 14 Dec 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New or Flare of Musculoskeletal Rheumatic Diseases After Different COVID-19 Vaccines: Multicentre Study
- ClinicalTrials.gov ID
- NCT05160428
- Acronym / sponsor ID
- PoCov-ARD / Post Covid Vaccination ARD
- Conditions
- COVID-19, Vaccination; Infection, Rheumatic Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligibility Criteria: Patients above 18 years old having MRD manifestations vaccinated against covid-19.
Key inclusion criteria (1 listed)
- Age above 18 years Vaccinated against covid-19 (one dose or fully vaccinated)
Key exclusion criteria (1 listed)
- Receiving other vaccine e.g influenza Less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 vaccinationdifferent types of covid-19 vaccinations. | Biological | – |
Primary outcome
-Prevalence of new ARD after covid-19 vaccinations
Time frame: 3 moths
any ARD
prevalence of flare of ARD after covid-19 vaccinations
Time frame: 3 months
flare of any manifestations of the disease
5 secondary outcomes
Prevalence of non-specific MSK symptoms after Covid-19 vaccine.
Time frame: 3 months
Correlation of the MSK to the 1st and 2nd Covid vaccine dose
Time frame: 3 months
comparison between different type of covid-19 vaccine in inducing ARD or flare up.
Time frame: 3 months
disease activity status in the patients who developed the ARD symptoms before and after the vaccine.
Time frame: 3 months
Any correlation between the appearance of MSK symptoms and the patient's medications
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Abuzaid, MD principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Vaccination; Infection, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mervat Eissa, MD (+201221738939, metvateissa@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-Prevalence of new ARD after covid-19 vaccinations (time frame: 3 moths). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.