NCT06831799

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

Completed Last updated 18 February 2025

What this trial tests

trial testing Non applicable, is a patient registry in Hemoglobinopathies in 684 participants. Completed in 31 December 2023.

Timeline

15 April 2020

Primary endpoint
30 June 2023

31 December 2023

Quick facts

Lead sponsor	Hospital Universitari Vall d'Hebron Research Institute
Status	Completed
Study type	OBSERVATIONAL
Enrollment	684
Start date	15 April 2020
Primary completion	30 June 2023
Estimated completion	31 December 2023
Sites	1 location across Spain

Drugs / interventions tested

• Non applicable, is a patient registry

Conditions studied

• Hemoglobinopathies — all drugs for Hemoglobinopathies →
• Sickle Cell Disease — all drugs for Sickle Cell Disease →
• Sickle Cell Anemia — all drugs for Sickle Cell Anemia →
• Sickle Beta Thalassemia — all drugs for Sickle Beta Thalassemia →

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Who can join

Eligibility, any sex, with Hemoglobinopathies or Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.