COVID-19 VaccineNCT05455983
COVID-19 Vaccine and Development of Immune Thrombocytopenic Purpura
An observational study of COVID-19 Vaccine, run by Assiut University at 1 site in Egypt.
Trial summary
Detect development of immune thrombocytopenic purpura (ITP) after different types of (COVID-19) vaccination Read more about this study
- Who is it for?
- Ages 17 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccine
- What is being tested?
- covid19 vaccines
- Type of treatment
- Vaccines
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Dec 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 17 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- Patients who already diagnosed ITP
- Patients with other possible causes of thrombocytopenia
- Patients with autoimmune disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Egypt
Asyut
Shymaa M Ismail, doctor, 01064972469, shymaaismail129@gmail.com
Rania M Hafez, Assist.Prof, 01000019198, raniahafez@aun.edu.eg
About this study
Official title: 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
Read the 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.
- Conditions
- COVID-19 Vaccine
- Being tested
- covid19 vaccines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
covid19 vaccinesBiological
different types of (COVID-19) vaccination
What is being measured
The primary outcome is the main question the study is designed to answer.
different types of COVID19 vaccines and development of ITP
detect development of immune thrombocytopenic purpura (ITP) after different types of (COVID-19) vaccination.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COVID-19 VaccineStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shymaa Mohamed Ismail, Assiut University
- Investigators
- Ahmed F Thabet, Professor, Study director, Assiut UniversityRania M Hafez, Assist. Prof, Study chair, Assiut UniversityShymaa M Ismail, Doctor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455983
- Sponsor's protocol ID
- COVID-19 and ITP
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31770441Kistangari G, McCrae KR. Immune thrombocytopenia. Hematol Oncol Clin North Am. 2013 Jun;27(3):495-520. doi: 10.1016/j.hoc.2013.03.001.
PubMed 23714309El 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.
PubMed 26436850Julian 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.
PubMed 34030782Cortelazzo 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.
PubMed 1984800Cecinati 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.
PubMed 23324619Du 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.
PubMed 33647938
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Different Types of COVID-19 Vaccine and Development of Immune Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT05455983
- Acronym / sponsor ID
- COVID-19 and ITP
- Conditions
- COVID-19 Vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 13 Jul 2022 (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.
Detect development of immune thrombocytopenic purpura (ITP) after different types of (COVID-19) vaccination
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who already diagnosed ITP
- Patients with other possible causes of thrombocytopenia
- Patients with autoimmune disorders
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 |
|---|---|---|
| covid19 vaccinesdifferent types of (COVID-19) vaccination | Biological | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Results publication: PubMed 31770441Provan 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.
- Results publication: PubMed 23714309Kistangari G, McCrae KR. Immune thrombocytopenia. Hematol Oncol Clin North Am. 2013 Jun;27(3):495-520. doi: 10.1016/j.hoc.2013.03.001.
- Results publication: PubMed 26436850El 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.
- Results publication: PubMed 34030782Julian 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.
- Results publication: PubMed 1984800Cortelazzo 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.
- Results publication: PubMed 23324619Cecinati 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.
- Results publication: PubMed 33647938Du 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.
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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.
Ahmed F Thabet, Professor study director
Assiut University
Rania M Hafez, Assist. Prof study chair
Assiut University
Shymaa M Ismail, Doctor principal investigator
Assiut 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 Vaccine, run by Assiut 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 3 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 13 Jul 2022. 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 Shymaa M Ismail, doctor (01064972469, shymaaismail129@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
different types of COVID19 vaccines and development of ITP (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05455983, which also lists 7 linked publications.
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 13 Jul 2022.