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临床试验/NCT05677750
NCT05677750已完成不适用

Hematological Disorders Associated With COVID-19 Infection

Assiut University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Complete hematological profile

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Complete hematological profile

时间窗: 12 month

1. CBC 2. liver function test 3. renal chemistry 4. Coomb's test 5. serum ferritin 6. D-dimmer 7. C reactive protein

PCR &Ab titre for COVID-19

时间窗: 12 months

Bone marrow aspirate& biopsy:

时间窗: 12 month

to detect BM Cellularity

CD55, CD59 flowcytometry

时间窗: 12 month

to exclude PNH

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mai Ali Abdelfatah Ahmed

Lecturer

Assiut University

研究点 (1)

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