COVID-19 Vaccine and Development of Immune Thrombocytopenic Purpura
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|ClinicalTrials.gov Identifier: NCT05455983|
Recruitment Status : Recruiting
First Posted : July 13, 2022
Last Update Posted : July 13, 2022
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|Condition or disease||Intervention/treatment|
|COVID-19 Vaccine||Biological: covid19 vaccines|
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|
|Estimated Enrollment :||500 participants|
|Official Title:||Relationship Between Different Types of COVID-19 Vaccine and Development of Immune Thrombocytopenic Purpura|
|Estimated Study Start Date :||August 1, 2022|
|Estimated Primary Completion Date :||August 1, 2023|
|Estimated Study Completion Date :||December 1, 2023|
- Biological: covid19 vaccines
different types of (COVID-19) vaccination
- 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.
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|Ages Eligible for Study:||17 Years to 60 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
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:
- complete physical examination
- complete blood count
- virulogy markers
- liver and kidney functions
- 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
- 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
- Patients who already diagnosed ITP
- Patients with other possible causes of thrombocytopenia
- Patients with autoimmune disorders
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05455983
|Contact: Shymaa M Ismail, firstname.lastname@example.org|
|Contact: Rania M Hafez, assist. email@example.com|
|Contact: Shymaa M Ismail, doctor 01064972469 firstname.lastname@example.org|
|Contact: Rania M Hafez, Assist.Prof 01000019198 email@example.com|
|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|
|Responsible Party:||Shymaa Mohamed Ismail, doctor, Assiut University|
|Other Study ID Numbers:||
COVID-19 and ITP
|First Posted:||July 13, 2022 Key Record Dates|
|Last Update Posted:||July 13, 2022|
|Last Verified:||July 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Immune System Diseases
Purpura, Thrombocytopenic, Idiopathic
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Blood Coagulation Disorders
Blood Platelet Disorders