Clinical trial NCT05677750: Hematological Disorders Associated With COVID-19 Infection
Official title: Hematological Disorders Associated With COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematological Condition With COVID19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 40 patients with newly diagnosed aplastic anemia, ITP, AIHA, Evan syndrome. aged one year and older attending Pediatric Hematology Unit at Children University Hospital

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)

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

Primary outcomes:
measure: Complete hematological profile
timeFrame: 12 month
measure: Bone marrow aspirate& biopsy:
timeFrame: 12 month
measure: CD55, CD59 flowcytometry
timeFrame: 12 month
measure: PCR &Ab titre for COVID-19
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Facility of medicine
Study officials:
affiliation: Assiut University
name: Mai AA Ahmed, MD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mervat A Amin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Mustafa M Embaby, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: Khalid E Elsayh, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: Dalia T Kamel, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: Ebtisam SA Hassanin, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: Hyam Hassan, MD
role: STUDY_CHAIR
References: