Hematological Disorders Associated With COVID-19 Infection

NCT ID: NCT05677750

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-10-01

Brief Summary

The emergence of the Coronavirus Disease -19 (COVID-19) pandemic, has had a tremendous global impact, resulting in substantial morbidity and mortality worldwide.

Although involvement of the lower respiratory track accounts for most of the morbidity and mortality seen, the virus involves several organ systems and the syndrome exhibits clinical diversity with a wide range of symptoms and manifestations.

Aim of this study is to evaluate if there is a casual relationship between the development of aplastic anemias& other immune cytopenias, and recent COVID-19 infection.

Detailed Description

Viruses are a form of life that possess genes but do not have a cellular structure. Viruses do not have their own metabolism, and they require a host cell to make new products; therefore, they cannot naturally reproduce outside a host cell (1).

From the hematologist point of view, viruses can play a major role in four conditions: causing infections; causing lymphoproliferations and/or malignancies; causing (pan)cytopenia; and used as vectors in treatment (e.g., gene therapy, CAR-T cells)(2).

Taking into the role of viruses in hematology, pancytopenia, aplastic anemia, and other immune-mediated cytopenias are reported to be related to HIV, Hepatitis viruses, Dengue virus; respiratory infections (community-acquired respiratory virus infections; CARV) caused by Orthomyxoviruses (e.g., influenza A/B), Paramyxoviruses (e.g., human parainfluenza virus PIV-1, -2, -3, and -4; respiratory syncytial virus RSV-A and -B), Picornaviruses (e.g., human rhinovirus), coronaviruses (e.g., human coronavirus), Pneumoviridiae (e.g., human metapneumovirus), and potentially other viruses. (2) A new type of Coronavirus was identified by Chinese authorities in mid-December 2019, named by the Coronavirus Study Group of the International Commission on Virus Classification as "Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)" and the disease was named by the World Health Organization (WHO) as coronavirus disease-2019 (COVID-19). The new virus quickly spread around the world, being declared a pandemic in March 2020.(3) The published data have focused on severe respiratory manifestations, found predominantly in adults, while in children the clinical manifestations are mostly asymptomatic and mild. When the disease is more severe in children, it occurs more frequently in those with less than one year of age or with pre-existing illnesses.(4) Hematological changes are frequent in the COVID-19 disease, such as early lymphopenia and, as the disease progresses, anemia and neutrophilia.(5) Thrombocytopenia can occur secondary to sepsis, disseminated intravascular coagulation or drug-induced,(5) as well as direct bone marrow suppression or immune-mediated destruction.(6)

Conditions

Hematological Condition With COVID19

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

newly diagnosed aplastic anemia, ITP, AIHA, Evan syndrome

40 patients with newly diagnosed aplastic anemia, ITP, AIHA, Evan syndrome. aged one year and older attending Pediatric Hematology Unit at Children University Hospital in Assiut Univesity will undergo the following:

1. History& Physical Examination:

History and physical findings will be recorded on a standard data collection sheet.

2. Bone marrow aspirate and biopsy:

3. CD 55, CD 59 Flowcytometric markers:

4. PCR for COVID-19& Antibody for COVID-19

5. Biologic (Lab) tests:

Venous blood samples were obtained for:

• CBC with reticulocytic count and differential
• Platelet lymphocyte ratio&neutrophil lymphocyte ratio
• Coagulation profile with PT, PC, INR, PTT
• Inflammatory markers(ESR,CRP)
• Serum ferritin, fibrinogin, D-dimer,.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• At least one year and less than or equal to 18 years of age
• Newly Diagnosed aplastic anemia, ITP, Autoimmune hemolytic anemia, or Evan syndrome
• Written consent according to institutional guidelines

Exclusion Criteria

• Hepatitis-associated aplastic anemia (HAAA)
• megaloblastic anemia, bone marrow infiltration (by various cancers or myelofibrosis), and myelodysplastic syndrome or
• acute leukemia.
• Constitutional aplastic anemia
• Any inherited cytopenias
• No written consent

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mai Ali Abdelfatah Ahmed

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mai AA Ahmed, MD

Role: STUDY_DIRECTOR

Assiut University

Mervat A Amin, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Mustafa M Embaby, MD

Role: STUDY_CHAIR

Assiut University

Khalid E Elsayh, MD

Role: STUDY_CHAIR

Assiut University

Dalia T Kamel, MD

Role: STUDY_CHAIR

Assiut University

Ebtisam SA Hassanin, MD

Role: STUDY_CHAIR

Assiut University

Hyam Hassan, MD

Role: STUDY_CHAIR

Assiut University

Locations

Facility of medicine

Asyut, , Egypt

Countries

Egypt

Other Identifiers

17300633

Identifier Type: -

Identifier Source: org_study_id