Parvovirus B19 Infection in Hereditary Hemolytic Anemias Patients

NCT04822090 | Unknown

• 1 other identifier: Soh-Med-21-02-23
• Study Type: observational
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

Although many studies investigated the prevalence and manifestations of HPV-B19 infection in patients with sickle cell anemia (SCA), thalassemia, and hereditary spherocytosis (HS) separately, there is limited information about the extent to which HPV-B19 infection leads to severe complications and chronic infection.

Conditions

Parvovirus B19 Infection

Keywords

Parvovirus B19; Hereditary Hemolytic Anemias; Extreme Hyperbilirubinemia

Outcome Measures

Primary Outcomes (7)

• Number of hereditary hemolytic anemias (HHA) patients with symptomatic HPV-B19 infection

  During the study period, any HHA-patient will have manifestations suggesting HPV-B19 infection (fever/ muscle pains /rash/ arthropathy/ lymphadenopathy/ rapid drop in (hemoglobin) Hb level and reticulocytopenia) and/or contact with a suspected case of erythema infectiosum will be investigated for anti-parvovirus B19 IgM and IgG immunoglobulin status. Those HPV-B19 seronegative will be retested 2 to 3 weeks later. HPV-B19 immunoglobulins (IgM and IgG) status will be determined by chemiluminiscent immunoassays (CLIA) technology from (Diasorin, Saluggia, Italy). The presence of signs, symptoms, HPV-B19 specific IgM, and absence of IgM of other viruses will be considered as a proof of recent symptomatic HPV-B19 infection. Patients will be divided based on previous criteria into two groups. Group I= HHA patients with acute symptomatic HPV-B19 infection, Group II= HHA patients without acute symptomatic HPV-B19 infection.

  2 years

• Common clinical manifestations of symptomatic HPV-B19 infection in patients with HHA

  A questionnaire about the occurrence of. (Fever/ muscle pains /rash/ arthropathy / lymphadenopathy/ worsening of anemia/ Heart failure/ neuropathy) will be performed to determine the clinical manifestations of symptomatic HPV-B19 infection among patients with HHA.

  2 years

• Number of cytopenias

  Complete blood count (CBC): peripheral blood samples will be withdrawn for diagnostic laboratory investigations and routine follow-up. 2- ml blood will be collected on potassium- ethylene diamine tetra-acetic acid (EDTA) anticoagulant coated tube for CBC using Cell-Dyn 3700, automated cell counter (Abbott diagnostic, Dallas, USA). The number of reticulocyte counts will be reported also.

  2 years

• Number of patients presenting with extreme hyperbilirubinemia during HPV-B19 infection

  Measurement of direct and indirect bilirubin level which will be performed on Cobas c 311\& modular P auto analyzer (Roche diagnostics, Mannheim, Germany). Extreme hyperbilirubinemia will be considered when total bilirubin \>25 mg/dL.

  2 years

• Frequency of autoimmune bone marrow failure

  The diagnosis of autoimmune bone marrow failure will be determined using several methods such as detection of 1. Several autoantibodies (antinuclear antibodies (ANA), anti-double-stranded DNA (anti-dsDNA)), coombs test with pancytopenia and hypocellular bone marrow (BM) 2. Detection of the percentage of lymphocytes subsets, cytotoxic T cells and T helper cells, and regulatory T cells in the bone marrow by flowcytometry 3. Bone marrow aspiration if the patient had severe persistent cytopenia with histopathological studies of BM

  2 years

• Frequency of autoimmune hepatitis

  The diagnosis of autoimmune hepatitis (AIH) will be determined using AIH diagnosis last guidelines to diagnose and management of AIH in adults (.Revised Original Pretreatment Scoring System of the International Autoimmune Hepatitis Group) by:- 1. Detection of autoimmune hepatitis antibodies and immunoglobulin G level 2. Exclusion of other viral causes of hepatitis by serology and PCR of HAV, HBV, HCV, EBV, CMV 3. Exclusion of Wilson disease by serum ceruloplasmin, 24-hour urinary copper, 4. Exclusion of hemochromatosis by serum ferritin level 5. Histopathological studies of liver biopsies will be done after patients' acceptance in restricted conditions and according to guidelines for indication of biopsy.

  Through study completion

• Frequency of renal involvement and acute kidney injury

  The diagnosis of acute kidney injury (AKI) using AKI diagnosis last guidelines (Kidney Disease: Improving Global Outcomes KDIGO) and renal involvement will be determined by:- 1. Serum creatinine and blood urea 2. Urine amount and analysis 3. Albumin creatinine ratio 4. Histopathological studies of renal will be performed according to indication.

  Through study completion

Secondary Outcomes (2)

• Number of patients with HPV-B19 reinfection during short term follow-up period (one year)

  1 year post HPV-B19 infection

• Frequency of HPV-B19 reinfection during 3 years follow-up period and COVID-19 outbreak

  3 years post HPV-B19 infection

Study Arms (2)

Group I

HHA patients with acute symptomatic HPV-B19 infection

Other: Supportive treatment with or without red cell transfusion/intravenous immune globulin (IVIG)

Group II

HHA patients without acute symptomatic HPV-B19 infection

Interventions

Supportive treatment with or without red cell transfusion/intravenous immune globulin (IVIG) OTHER

red cell transfusion; plasma exchange; renal replacement therapy; intravenous immunoglobulin. plasma exchange

Group I

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HHA Patients will be classified according to of presence or absence of acute symptomatic HPV-B19 infection

You may qualify if:

• Confirmed hereditary hemolytic anemias patients (age above 12 years) presented with signs and symptoms of hereditary hemolytic anemia (HHA) and admitted or treated in emergency departments or Hematology Units at Internal Medicine Departments of various university hospitals will be screened for enrollment in this study.

You may not qualify if:

• Patients will be diagnosed with non-HHA as ( autoimmune hemolytic anemia, microangiopathic hemolytic anemia (MAHA), Wilson disease, paroxysmal nocturnal hemoglobinuria (PNH).
• HHA-patients will refuse to consent to this study.
• Serologic evidence of recent virus infection other than human parvovirus B19 (HPV-B19); hepatitis A (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis E virus (HEV,) cytomegalovirus (CMV), Epstein-Barr virus (EBV), or positive test for HIV.
• HHA patients with uncontrolled diabetes mellitus (DM).
• HHA patients with a history of nephrotic syndrome or chronic kidney disease(CKD).
• HHA patients with a history of treatment by immunosuppressive drugs.
• HHA patients with clinical and laboratory evidence of relevant toxicity related to iron chelation.
• HHA patients with severe systemic diseases (such as cardiovascular, renal, and hepatic disease) or surgical/medical conditions that might interfere with follow-up instructions.
• HHA patients with a life expectancy of less than 1 year.
• HHA patients with psychiatric disorders or a history of drug abuse,
• Pregnant women will be also excluded.
• Patients are not a candidate for investigation (Refusal

Sponsors & Collaborators

• Sohag University: lead
• Assiut University: collaborator

Study Sites (1)

, Faculty of Medicine, Sohag University

Sohag, 82524, Egypt

Location

MeSH Terms

Conditions

Erythema Infectiosum; Anemia, Hemolytic, Congenital

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Parvoviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Erythema; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Infectious; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mahmoud Yousef, MD, PhD

  , Faculty of Medicine, Sohag University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 30, 2021
• Study Start: February 10, 2018
• Primary Completion: February 10, 2021
• Study Completion: February 10, 2024
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)