Hematological Disorders Associated With COVID-19 Infection (HEMATOCOVID)

January 6, 2023 updated by: Mai Ali Abdelfatah Ahmed, Assiut University

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.

Study Overview

Status

Completed

Conditions

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)

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Facility of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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,.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete hematological profile
Time Frame: 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
12 month
Bone marrow aspirate& biopsy:
Time Frame: 12 month
to detect BM Cellularity
12 month
CD55, CD59 flowcytometry
Time Frame: 12 month
to exclude PNH
12 month
PCR &Ab titre for COVID-19
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Mai AA Ahmed, MD, Assiut University
  • Principal Investigator: Mervat A Amin, MD, Assiut University
  • Study Chair: Mustafa M Embaby, MD, Assiut University
  • Study Chair: Khalid E Elsayh, MD, Assiut University
  • Study Chair: Dalia T Kamel, MD, Assiut University
  • Study Chair: Ebtisam SA Hassanin, MD, Assiut University
  • Study Chair: Hyam Hassan, MD, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

July 30, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 6, 2023

First Posted (Estimate)

January 10, 2023

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17300633

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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