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Completed

NCT Number: NCT06831799

ERN-EuroBloodNet Registry on Patients With Rare Red Blood Cell Defects and COVID-19

Patients with red blood cell disorders (RBCDs), such as Sickle cell disease (SCD) and Thalassemia, are chronic, life-threatening conditions that can become multi-organ complications over time, and are likely at an increased risk of COVID-19-related complications. Patients at the highest risk include the elderly (>50 in our population), those with a history of respiratory or cardiac disease and those with other comorbidities. Several patients affected by RBCDs undergo splenectomy as therapeutic option to improve their level of hemoglobin concentration. Splenectomized patients, or in the case of SCD with functional hyposplenism, are more vulnerable to bacterial infections / superinfections after viral infection. Acute pulmonary syndrome (ACS) is the main cause of morbidity in SCD in middle-high income countries, and is often triggered by infectious events. Currently, there is no literature on the subject. Thus, any recommendation available comes from the experience gained with previous Coronaviruses infections. Accordingly, the correct treatment and management of infection by Coronavirus SARS-COV-2 (COVID-19) in patients affected by RBCDs may be challenging given the rapid spread of the pandemic and limited literature so far, especially in some countries. Accordingly, there is an urgent need to pool evidence in a unique repository on patients affected by RBCDs and COVID-19 in order to reach critical numbers to facilitate the medical decision making process across Europe.

The Registry on patients with rare RBCDs and COVID-19 is an initiative conceived in the core of the European Reference Network on Rare Hematological Diseases (ERN-EuroBloodNet, FPA 739541, www.eurobloodnet.eu) aiming at supporting medical practice of COVID-19 in these patients by gathering evidence on pediatric and adult COVID-19 confirmed cases in RBCDs across Europe.

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Key information

Conditions

Hemoglobinopathies Alpha-Thalassemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Beta Thalassemia Intermedia Beta Thalassemia Major Beta Thalassemia, Dominant Inclusion Body Type Beta-Thalassemia COVID-19 Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronaviridae Infections Coronavirus Infections Delta-Beta Thalassaemia Delta-Beta Thalassemia Dominant Beta-Thalassemia Elliptocytosis, Hereditary Enzyme Disorder; Anemia Genetic Diseases, Inborn Haemoglobin C-Beta-Thalassaemia Syndrome Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobin Barts Hydrops Hemoglobin E-Beta Thalassemia Hemoglobin H Disease Hemoglobin SC Disease Hereditary Persistence of Fetal Hemoglobin Thalassemia Infections Lung Diseases Membranes; Disorder Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sickle Beta Thalassemia Sickle Cell Anemia Sickle Cell Disease Sickle Cell Hemoglobin C Sickle Cell Hemoglobin D Sickle Cell-Hemoglobin E Disease Sickle-Cell; Hemoglobinopathy Spherocytosis, Hereditary Stomatocytosis Thalassemia Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Vall d'Hebron Institut de Recerca

Barcelona, 08035, Spain

About this study

The Registry on patients with rare red blood cell disorders (RBCDs) and COVID-19 is an initiative conceived in the core of the European Reference Network on Rare Hematological Diseases (ERN-EuroBloodNet, FPA 739541, www.eurobloodnet.eu) aiming at supporting medical practice of COVID-19 in these patients by gathering evidence on pediatric and adult COVID-19 confirmed cases in RBCDs across Europe.

Primary objective of the registry is to pool evidence on the clinical management and outcomes of patients affected by red blood cell disorders and COVID-19 for supporting daily medical practice while enabling inter-professional consultation of complex cases. Secondary objective includes the performance of observational studies in the different cohorts of patients, including Sickle Cell Disease, Thalassaemia, Enzymopathies and Membranopathies patients in pediatric and or adult stages.

The network of hospitals that will be created from this registry will hold regular meetings to analyze the data that are being introduced and to discuss possible measures against COVID-19 based on them. The collaboration will continue with the development of observational studies that will give the necessary evidence to make recommendations for COVID-19 management in hematological patients.

METHODOLOGY

Inclusion criteria

include both pediatric and adults patients with confirmed COVID-19 and affected by a rare anaemia disorder due to a red blood cell defect. Data set elements include:

  • Demographics: country of living, sex, age (only year of birth)
  • Data related to Red blood cell disorder: diagnosis, co-morbidities, treatments, splenectomy, blood transfusion requirement.
  • Data related to COVID-19: date and method for diagnosis, severity grade, clinical manifestations i.e. pneumonia, symptoms days, acute events, treatments, days of hospitalization, days at intensive care unit, sequela, death.

The registry has been developed by Vall d'Hebron Research Institute using Redcap, a secure web application for building and managing online databases. Individual patients' data will be gathered in a codified way.

ETHICS AND GDPR COMPLIANCE

The processing of personal data is conducted fully respecting the Regulation (EU) 2016/679 (General Data Protection Regulation), including legal basis and special requirements and safeguards to ensure the safety and the confidentiality of the data subjects.

The Research Ethics Committee of the Vall d'Hebron's Hospital has confirmed that this exceptional case justifies the waiver of informed consent.

PROCESSING OF THE DATA

The patient's information included in the database is pseudonymised by single codification. The minimization principle of data protection is followed (i.e. only year of age is collected, no identified data is collected, and only clinical data of the health care is collected). The medical doctors at each center have a coding table in which the code can be linked to the patient's personal information. This table is safely guarded by the medical doctor and never leaves the center. All the information stored in the database is pseudonymised.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients both pediatric and adults with confirmed COVID-19 and affected by a rare anaemia disorder due to a red blood cell defect

Treatment and study plan

Non applicable, is a patient registry

Other

Non applicable, is a patient registry

Primary outcomes

  1. Clinical Management and Outcomes in Patients with Red Blood Cell Disorders and COVID-19

    Time frame: Through study completion, an average of 3 years

    • COVID-19 clinical manifestations and required treatment in each cohort (Sickle Cell Disease, Thalassemia, Enzymopathies, and Membranopathies)..

Secondary outcomes

  1. Secondary Analysis in Different Cohorts of Patients with Red Blood Cell Disorders and COVID-19:

    Time frame: Through study completion, an average of 3 years

    • Descriptive analysis of demographic and baseline disease characteristics in each cohort (Sickle Cell Disease, Thalassemia, Enzymopathies, and Membranopathies).
    • COVID-19 clínical manifestations in each cohort.
    • Identification of preventive measures and risk factors related to severe COVID-19 in each cohort

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Aghia Sophia Children's Hospital of Athens
  • Amsterdam UMC
  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
  • Azienda Ospedaliera di Padova
  • Brno University Hospital
  • Children's Health Ireland
  • Cyprus Institute of Neurology and Genetics
  • Erasme University Hospital
  • European Georges Pompidou Hospital
  • General Hospital of Athens Elpis
  • Guy's and St Thomas' NHS Foundation Trust
  • Hospital General Universitario Gregorio Marañon
  • Hospital Vall d'Hebron
  • Hôpital Necker-Enfants Malades
  • Institute of Hematology and Blood Transfusion, Czech Republic
  • Oxford University Hospitals NHS Trust
  • Palacky University
  • San Luigi Gonzaga Hospital
  • UMC Utrecht
  • Unidade Local de Saúde de Coimbra, EPE
  • Universitaire Ziekenhuizen KU Leuven
  • University Hospital Freiburg
  • University Hospital Heidelberg
  • University Hospital, Gentofte, Copenhagen

Registry information

Official study title

ERN-EuroBloodNet European Collaborative Platform to Share COVID-19 Data in Patients With Red Blood Cell Disorders in Real Time

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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