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History of Changes for Study: NCT04746066
Observational Study for Patients With Hemoglobinopathies and Rare Inherited Anemia and Covid 19
Latest version (submitted May 4, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 8, 2021 None (earliest Version on record)
2 February 9, 2021 Contacts/Locations, Study Status and Study Identification
3 May 4, 2022 Recruitment Status, Contacts/Locations and Study Status
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Study NCT04746066
Submitted Date:  February 8, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: EMOAERCOVID19
Brief Title: Observational Study for Patients With Hemoglobinopathies and Rare Inherited Anemia and Covid 19
Official Title: Observational Study Multicentric Phamacological no Profit for the Treatment of Patients With Hemoglobinopathies and Rare Inherited Anemia Affected by Covid 19
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2021
Overall Status: Active, not recruiting
Study Start: March 31, 2020
Primary Completion: December 2030 [Anticipated]
Study Completion: December 2030 [Anticipated]
First Submitted: February 2, 2021
First Submitted that
Met QC Criteria:
February 8, 2021
First Posted: February 9, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
February 8, 2021
Last Update Posted: February 9, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Società Italiana Talassemie ed Emoglobinopatie
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

The COVID-19 pandemic is causing many deaths around the world, putting a strain on health services. Patients with pre-existing chronic conditions are most affected by the SARS-COV2 infection. Infectious complications are a common cause of mortality and one of the main causes of morbidity in all these diseases. The main objective of this project is the assessment of patients with thalassemia, drepanocytosis, other haemoglobinopathies and rares inherited anemias suffering from SARS-COV-2 to:

  1. Obtain clinical and epidemiological data that can provide information on a possible increased vulnerability of these patients to SARS-COV-2 infection;
  2. Sharing therapeutic approaches considering the lack of information about the treatment.
Detailed Description:

The COVID-19 pandemic is causing many deaths around the world, putting a strain on health services. Patients with pre-existing chronic diseases are most affected by SARS-COV2 infection. Italy is one of the countries most involved. Thalassaemia, drepanocytosis, other hemoglobinopathies and inherited anemias are widespread in italy and the mediterranean area. Thalassaemia syndromes are characterized by different clinical forms with mutations in globin genes that cause the reduction or complete absence of synthesis of the globin chain. Transfusion therapy remains the basis of thalassaemia management. Based on the extent of the severity of anemia and clinical presentation, thalassaemia was classified as transfusion-dependent (TDT) and non-transfusion-dependent (NTDT). Transfusion inevitably contributes to iron overload, which is associated with secondary morbidity, including organ damage, especially heart, liver, bone tissue, and endocrine glands. In ntdt, comorbility is mainly related to chronic anemia and increased gastrointestinal iron adsorption.

Other inherited anaemias include a large group of pathologies such as: hyporegenerative anaemias, such as congenital diseritropoietic anaemia and diamond-blackfan anemia; anaemies from deficiency of red blood cell membrane proteins due to altered membrane structure, such as hereditary spherocytosis and hereditary ellipsocytosis, and impaired membrane transport function, such as hereditary stomatocytosis; anaemies due to enzymatic deficiency, the most frequent of which are pyruvate deficiency kinase and glucose-6 phosphate dehydrogenase; sideroblastic anaemias and all other hereditary microcytic anaemies such as irida. All these anemias are characterized by high phenotypic heterogeneity but in most cases chronic hemolytic anemia, iron overload and addiction transfusion are found (as a percentage of a variable of cases). Transfusion therapy remains the basis of the management of these anaemias along with splenectomy (not practicable in all these classes of anemia). As with thalassaemia syndromes, in such anaemias, we find secondary morbidity, such as heart, liver, and endocrine damage resulting from both chronic anemia and iron overload.

Infectious complications are a common cause of mortality and one of the main causes of morbidity in all these pathologies. The greater quantitative and functional quantities, the involve t and b lymphocytes, production of immunoglobulins, neutrophils and macrophages, chemotaxis and phagocytosis, as well as the complement system. Excess iron can alter the immune balance in favour of the growth of infectious organisms. Other factors include multiple transfusions, associated with constant allo-antigenic stimulation. A large percentage of adult patients are splenectomized and risk complications related to splenectomy such as capsuled bacterial infections and immune system changes; low levels of zinc, another immune regulator; iron chelation therapy, which predisposes to serious yersinia-like infections. The circulation of abnormal erythrocytes is the cause of another permanent immune stimulus. In addition, particularly in elderly patients, the coexistence of adrenal hypofunction makes the response to sepsis less effective.

However, we have no information on the vulnerability of patients with thalassaemia, drepanocytosis, other hemoglobinopathies and hereditary anemias to SARS-COV2 infection. In order to obtain more information useful to increase our knowledge, a retrospective survey has been planned.

The main objective of this project is the evaluation of patients with thalassaemia, drepanocytosis, other hereditary hemoglobinopathies and anaemias affected by SARS-COV2 to:

  1. obtain clinical and epidemiological data that may dare information on a possible increased vulnerability of these patients to SARS-COV2;
  2. share therapeutic approaches considering the lack of information about treatment.

This is an italian study of observational, pharmacological, non-interventional, retrospective, prospective and multicenter, non-profit cohort. Patients diagnosed with thalassaemia, drepanocytosis, other hemoglobinopathies and hereditary anaemia positive to the SARS-COV2 virus will be enlisted. Patient data from reference centers will be introduced into the card via a web service.

The scientific committee of the project has discussed and approved a set of data that will be collected by local centers and that will feed the data collection database.

The study will be launched in every Italian center that requires participation. The Italian Society of Thalassaemia and Hemoglobinopathies (SITE) in its role as a scientific reporting company for pathology and the Foranemia Foundation, a non-profit organization, makes available to the center of microcitemie, coordinator of the study, a special web space for online data collection assuming the costs.

Open or close this module Conditions
Conditions: Haemoglobinopathies
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Other
Time Perspective: Retrospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 10000 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of Patients with Covid 19 infection
[ Time Frame: through study completion, an average of 1 year ]

Incidence of Covid 19 infections in patient with Hemoglobinopathies and Rare Anemia inherit
Open or close this module Eligibility
Study Population: Patients with an established diagnosis of thalassemia, sickle cell disease, other haemoglobinopathies and Rare Anemia inherit
Sampling Method: Non-Probability Sample
Minimum Age:
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

INCLUSION CRITERIA:

  • Patients with an established diagnosis of thalassemia, sickle cell disease, other haemoglobinopathies and Rare Anemia inherit with a virological diagnosis of SARS-COV-2 infection.

EXCLUSION CRITERIA:

  • nobody
Open or close this module Contacts/Locations
Locations: Italy
Ospedali Galliera - S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro
Genova, Italy, 16128
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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