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.
