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AzTrials

HemoglobinopathiesNCT06831799

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

An observational study of Hemoglobinopathies and Sickle Cell Disease, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
What is being tested?
Non applicable, is a patient registry
How many people
684 participants
Where
1 siteSpain
Study dates
15 Apr 2020to 31 Dec 2023
How long will I take part?
1 Month
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients both pediatric and adults with confirmed COVID19 and affected by a rare anaemia disorder due to a red blood cell defect according to the following ORPHA codes for rare diseases: * 68364 Hemoglobinopathy * 275752 Sickle Cell Disease and related diseases * 848 Beta-thalassemia * 846 Alpha-Thalassaemia * 98363 Rare hemolytic anemia * 98369 Rare constitutional hemolytic anemia due to an enzyme disorder * 98364 Rare constitutional hemolytic anemia due to a red cell membrane anomaly

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Vall d'Hebron Institut de Recerca

    Barcelona, Barcelona, 08035

Other trials in Spain

About this study

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

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.

Read the detailed description

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.

Being tested
Non applicable, is a patient registry
Keywords
COVID-19, Hemoglobinopathy, Sickle cell disease, Sickle Cell Anemia, Sickle cell-beta-thalassemia, Sickle cell-hemoglobin, Beta-Thalassemia, Beta Thalassemia Major, Beta Thalassemia Intermedia, Delta-Beta Thalassaemia, Alpha-Thalassemia, Hemoglobin, Rare hemolytic anemia, Hereditary Spherocytosis, Hereditary Elliptocytosis, Hereditary Stomatocytosis
Medical subject headings
Hemoglobinopathies, Anemia, Sickle Cell, Hemoglobin SC Disease, beta-Thalassemia, Beta Thalassemia, Dominant Inclusion Body Type, Delta-Beta Thalassemia, alpha-Thalassemia, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non applicable, is a patient registryOther

    Non applicable, is a patient registry

Study groups in NCT06831799
Study groupRoleWhat they receive
Pediatric Sickle cell disease patients infected by COVID-19Sickle cell diagnosed patients (<18 years old) infected by COVID-19
Receives: Other: Non applicable, is a patient registry
Adult Sickle cell disease patients infected by COVID-19Sickle cell diagnosed patients (≥18 years old) infected by COVID-19
Receives: Other: Non applicable, is a patient registry
Pediatric Thalassemia patients infected by COVID-19Thalassemia-diagnosed patients (<18 years old) infected by COVID-19
Receives: Other: Non applicable, is a patient registry
Adult Thalassemia patients infected by COVID-19Thalassemia-diagnosed patients (≥18 years old) infected by COVID-19
Receives: Other: Non applicable, is a patient registry
Pediatric Enzymopathy patients infected by COVID-19Enzymopathy-diagnosed patients (<18 years old) infected by COVID-19
Receives: Other: Non applicable, is a patient registry
Adult Enzymopathy patients infected by COVID-19Enzymopathy-diagnosed patients (≥18 years old) infected by COVID-19
Receives: Other: Non applicable, is a patient registry
Pediatric Membranopathy patients infected by COVID-19Membranopathy-diagnosed patients (<18 years old) infected by COVID-19
Receives: Other: Non applicable, is a patient registry
Adult Membranopathy patients infected by COVID-19Membranopathy-diagnosed patients (<18 years old) infected by COVID-19
Receives: Other: Non applicable, is a patient registry

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Through study completion, an average of 3 years

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

    • 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

    Measured: Through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2025
  2. Study start15 Apr 2020
  3. Primary completion30 Jun 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
Enrolment
684 participants (actual)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT06831799
Sponsor's protocol ID
VHI-ERN-2020-00
Other IDs
PR(AG)215/2020
Status last verified
Feb 2025
First submitted
17 Feb 2023
Last updated
18 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hemoglobinopathies and Sickle Cell Disease, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Management and Outcomes in Patients with Red Blood Cell Disorders and COVID-19 (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.

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