Brief 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. 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

684

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.7 years study duration

Study Start

First participant enrolled

April 15, 2020

Completed

2.8 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2023

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed

1.1 years until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed

Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

3.2 years

First QC Date

February 17, 2023

Last Update Submit

February 14, 2025

Conditions

Keywords

COVID-19HemoglobinopathySickle cell diseaseSickle Cell AnemiaSickle cell-beta-thalassemiaSickle cell-hemoglobinBeta-ThalassemiaBeta Thalassemia MajorBeta Thalassemia IntermediaDelta-Beta ThalassaemiaAlpha-ThalassemiaHemoglobinRare hemolytic anemiaHereditary SpherocytosisHereditary ElliptocytosisHereditary Stomatocytosis

Outcome Measures

Primary Outcomes (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)..
Through study completion, an average of 3 years

Secondary Outcomes (1)

Secondary Analysis in Different Cohorts of Patients with Red Blood Cell Disorders and COVID-19:
Through study completion, an average of 3 years