COVID-19 Vaccine and Development of Immune Thrombocytopenic Purpura

July 12, 2022 updated by: Shymaa Mohamed Ismail, Assiut University

Relationship Between Different Types of COVID-19 Vaccine and Development of Immune Thrombocytopenic Purpura

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Immune thrombocytopenia (ITP) is an acquired hemorrhagic diathesis characterized by a platelet count of < 100×109/L caused by immune-mediated destruction of platelets, impaired production or increased splenic sequestration. Primary ITP is a hematologic disorder characterized by isolated thrombocytopenia (platelet count of <100,000/uL) without associated leukopenia or anemia , without changes of the bone marrow and representing about 80% of cases. Secondary ITP is defined as any form of ITP other than the primary kind and usually secondary to an underlying precipitating etiology, as autoimmune pathology (e.g. systemic lupus erythematosus), viral infections (chronic hepatitis C virus, HIV, CMV, or varicella-zoster virus), medications, rheumatologic disorders, lymphoproliferative neoplasms. The term of acute ITP, recently replaced by newly diagnosed ITP, has less than 3 months from diagnosis. Persistent ITP refers to immune thrombocytopenia with 3 months to 1-year evolution, whereas chronic ITP is the disease longer than 12 months. Refractory ITP comprises cases which did not respond to splenectomy or relapsed after surgery, with high risk of bleeding, which makes it necessary to continue therapy.

The pathophysiology of ITP is uncertain; however, it is theorized that the acquired thrombocytopenia results from pathologic antiplatelet antibodies, impaired megakaryocytopoiesis, and T-cell-mediated destruction of platelets. ITP is primarily a diagnosis of exclusion, and the main characteristic of the disease is an increased peripheral destruction of platelets, the majority of patients showing anti-platelet membrane glycoproteins antibodies.

Patients may be asymptomatic at presentation or they may present with mild mucocutaneous to life-threatening bleeding, the intracranial one presenting the highest risk, Mortality by hemorrhage is 5% of cases.

The recent global pandemic of coronavirus disease 2019 (COVID-19) has led to vaccination in many parts of the world for herd immunity, and as vaccination has progressed, several rare adverse events have been reported. ITP has been associated with several types of vaccinations. Vaccine-related thrombocytopenia is considered to be of immune origin because antibodies can be detected on platelets in about 79% of cases. Various reports have shown that all of the live, attenuated viruses in the measles, mumps, and rubella (MMR) vaccine can cause ITP. Past studies have shown that the risk of developing ITP also increases after the administration of hepatitis A, varicella, and diphtheria-tetanus-pertussis vaccines in children and adolescents. Recently, a few case reports have shown a temporal relationship between receiving the coronavirus disease 2019 (COVID-19) vaccine and developing ITP of varying severity.

The Vaccine Adverse Effect Reporting System (VAERS) is a passive, voluntary reporting system that collects reports of adverse events associated with vaccination. VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. A review of VAERS data has revealed 22 reports of thrombocytopenia and 13 reports of ITP following COVID-19 vaccine administration. However, underreporting is one of the main limitations of passive surveillance systems including VAERS, and it is possible that the true number of cases is far higher, especially considering that most cases of ITP are asymptomatic.

It is impossible to strictly differentiate between vaccine-induced secondary ITP and incidental primary ITP that occurred soon after vaccination. However, of the cases identified so far, 22 occurred after the first vaccination and only one after the second vaccination. Since the frequencies of occurrence are highly uneven, there is likely to be a causal relationship between the COVID-19 vaccine and the development of ITP. Lee et al. also reported that symptoms of bleeding occurred between 1 and 23 days (median 5 days) after vaccine administration.

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 Contact Backup

Study Locations

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

17 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Patients who already diagnosed ITP
  2. Patients with other possible causes of thrombocytopenia
  3. Patients with autoimmune disorders

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
different types of COVID19 vaccines and development of ITP
Time Frame: Baseline
detect development of immune thrombocytopenic purpura (ITP) after different types of (COVID-19) vaccination.
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Ahmed F Thabet, Professor, Assiut University
  • Study Chair: Rania M Hafez, Assist. Prof, Assiut University
  • Principal Investigator: Shymaa M Ismail, Doctor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ANTICIPATED)

August 1, 2022

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

July 12, 2022

First Submitted That Met QC Criteria

July 12, 2022

First Posted (ACTUAL)

July 13, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-19 and ITP

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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