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Observational Study for Patients With Hemoglobinopathies and Rare Inherited Anemia and Covid 19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04746066
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
Società Italiana Talassemie ed Emoglobinopatie

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.

Condition or disease
Haemoglobinopathies

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Observational Study Multicentric Phamacological no Profit for the Treatment of Patients With Hemoglobinopathies and Rare Inherited Anemia Affected by Covid 19
Actual Study Start Date : March 31, 2020
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine





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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an established diagnosis of thalassemia, sickle cell disease, other haemoglobinopathies and Rare Anemia inherit
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04746066


Contacts
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Contact: Gian Luca Forni 0105634 ext 560 gianluca.forni@galliera.it

Locations
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Italy
E.O. Ospedali Galliera Recruiting
Genova, Italy, 16128
Contact: Gian Luca Forni, MD    +39 010 5634560    gianluca.forni@galliera.it   
Ospedali Galliera - S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro Recruiting
Genova, Italy, 16128
Contact: Gian Luca Forni, MD    +390105634560    gianluca.forni@galliera.it   
Sub-Investigator: Valeria M Pinto, MD         
Sponsors and Collaborators
Società Italiana Talassemie ed Emoglobinopatie
Investigators
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Principal Investigator: Gian Luca Forni Ospedali Galliera - SSD Microcitemia, anemie congenite e dismetabolismo del ferro
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Responsible Party: Società Italiana Talassemie ed Emoglobinopatie
ClinicalTrials.gov Identifier: NCT04746066    
Other Study ID Numbers: EMO AER COVID-19
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemoglobinopathies
Hematologic Diseases
Genetic Diseases, Inborn