NCT05455983

Brief Summary

Detect development of immune thrombocytopenic purpura (ITP) after different types of (COVID-19) vaccination

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 Aug 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

July 12, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

July 12, 2022

Last Update Submit

July 12, 2022

Conditions

COVID-19 Vaccine

Outcome Measures

Primary Outcomes (1)

  • different types of COVID19 vaccines and development of ITP

    detect development of immune thrombocytopenic purpura (ITP) after different types of (COVID-19) vaccination.

    Baseline

Interventions

covid19 vaccinesBIOLOGICAL

different types of (COVID-19) vaccination

Eligibility Criteria

Age17 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All Persons newly received COVID-19 vaccine at assiut university hospital from Decemper 2021 to April 2023 are eligible to be targeted and included in the study. Each patient will be submitted to: 1. complete physical examination 2. complete blood count 3. virulogy markers 4. liver and kidney functions 5. Antinuclear antibody(ANA),antibody to double stranded DNA antigen (antidsDNA) Follow up with CBC after two weeks and one month following the first and second dose of the vaccination

You may qualify if:

  • All Persons newly received COVID-19 vaccine at assiut university hospital from Decemper 2021 to April 2023 are eligible to be targeted and included in the study

You may not qualify if:

  • Patients who already diagnosed ITP
  • Patients with other possible causes of thrombocytopenia
  • Patients with autoimmune disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egypt

Asyut, Egypt

RECRUITING

Related Publications (7)

  • Provan D, Arnold DM, Bussel JB, Chong BH, Cooper N, Gernsheimer T, Ghanima W, Godeau B, Gonzalez-Lopez TJ, Grainger J, Hou M, Kruse C, McDonald V, Michel M, Newland AC, Pavord S, Rodeghiero F, Scully M, Tomiyama Y, Wong RS, Zaja F, Kuter DJ. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv. 2019 Nov 26;3(22):3780-3817. doi: 10.1182/bloodadvances.2019000812.

    PMID: 31770441RESULT

  • Kistangari G, McCrae KR. Immune thrombocytopenia. Hematol Oncol Clin North Am. 2013 Jun;27(3):495-520. doi: 10.1016/j.hoc.2013.03.001.

    PMID: 23714309RESULT

  • El Ghannam D, Fawzy IM, Azmy E, Hakim H, Eid I. Relation of interleukin-10 Promoter Polymorphisms to Adult Chronic Immune Thrombocytopenic Purpura in a Cohort of Egyptian Population. Immunol Invest. 2015;44(7):616-26. doi: 10.3109/08820139.2015.1064948.

    PMID: 26436850RESULT

  • Julian JA, Mathern DR, Fernando D. Idiopathic Thrombocytopenic Purpura and the Moderna Covid-19 Vaccine. Ann Emerg Med. 2021 Jun;77(6):654-656. doi: 10.1016/j.annemergmed.2021.02.011. Epub 2021 Feb 12. No abstract available.

    PMID: 34030782RESULT

  • Cortelazzo S, Finazzi G, Buelli M, Molteni A, Viero P, Barbui T. High risk of severe bleeding in aged patients with chronic idiopathic thrombocytopenic purpura. Blood. 1991 Jan 1;77(1):31-3.

    PMID: 1984800RESULT

  • Cecinati V, Principi N, Brescia L, Giordano P, Esposito S. Vaccine administration and the development of immune thrombocytopenic purpura in children. Hum Vaccin Immunother. 2013 May;9(5):1158-62. doi: 10.4161/hv.23601. Epub 2013 Jan 16.

    PMID: 23324619RESULT

  • Du J, Xiang Y, Sankaranarayanapillai M, Zhang M, Wang J, Si Y, Pham HA, Xu H, Chen Y, Tao C. Extracting postmarketing adverse events from safety reports in the vaccine adverse event reporting system (VAERS) using deep learning. J Am Med Inform Assoc. 2021 Jul 14;28(7):1393-1400. doi: 10.1093/jamia/ocab014.

    PMID: 33647938RESULT

MeSH Terms

Interventions

COVID-19 Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Ahmed F Thabet, Professor

    Assiut University

    STUDY DIRECTOR

  • Rania M Hafez, Assist. Prof

    Assiut University

    STUDY CHAIR

  • Shymaa M Ismail, Doctor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shymaa M Ismail, doctor

CONTACT

01064972469shymaaismail129@gmail.com

Rania M Hafez, assist. prof

CONTACT

01000019198raniahafez@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 13, 2022

Study Start

August 1, 2022

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

July 13, 2022

Record last verified: 2022-07

Locations

EG(1)