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Frequency of COVID-19 Antibodies in Patients With Hereditary Hematological Diseases (ThalaCoV)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04526405
Recruitment Status : Completed
First Posted : August 25, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
University of Milano Bicocca

Brief Summary:

In Italy there are about 5000 patients with dependent transfusion thalassemia (source Italian Thalassemia and Hemoglobinopathies - SITE) and a smaller number, currently not definable, of patients with sickle cell anemia in chronic transfusion.

A recent study in the Lombardy region identified the positivity of anti-Covid-19 antibodies in 4.5-7% of asymptomatic donors (Valenti L et al). As already known, a preliminary study conducted in Italy (Motta I et al, Hussain FA et al, Taher A et al) reported only 11 cases of symptomatic infection all with benign evolution. Currently there are 15 reported cases (12 thalassemias and 3 sickle cell anemias). 75% of the cases have been identified in Lombardy.

Our hypothesis is that in a percentage of polytransfused patients a transmission of the virus may have developed that stimulated the production of protective antibodies. This could be an explanation of the low contagiousness and severity of the infection in polytransfused patients. Currently no data are available for this purpose.

This study will be conducted in collaboration with the Microbiology Unit and involves the determination of SARS-CoV-2 antibodies (anti-s1 and s2) by CLIA method with a high sensitivity (94.7%) and specificity (98.5%).


Condition or disease Intervention/treatment
Thalassemia Major Covid19 Diagnostic Test: SARS-CoV-2 S1/S2 IgG

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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on the Frequency of COVID-19 Antibodies in Patients With Hereditary Hematological Diseases Subject to Chronic Transfusion Support.
Actual Study Start Date : July 14, 2020
Actual Primary Completion Date : November 3, 2020
Actual Study Completion Date : November 3, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: SARS-CoV-2 S1/S2 IgG
    SARS-CoV-2 S1/S2 IgG analysis


Primary Outcome Measures :
  1. Positive subjects [ Time Frame: 2 months ]
    On the basis of the few data available in Italy, the investigator foresees 5-10% of positive subjects.


Biospecimen Retention:   Samples Without DNA
Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Transfusion dependent patients affected by thalassemia, Blackfan-Diamond anemia, sickle cell anemia and other chronic anemias, belonging to the ASST-Monza Rare Disease Center, S. Gerardo Hospital and all residents in the provinces of Monza-Brianza, Como, Lecco, Varese and Milan.
Criteria

Inclusion Criteria:

  • Patients with inherited dependent transfusion anemias (thalassemia major and intermediate, sickle cell anemia and Blackfan-Diamond anemia) or undergoing recurrent transfusion procedures (erythro-exchange in sickle cell anemia), belonging to the Rare Disease Center - ASST-Monza, Hospital S Gerardo.
  • Age greater than or equal to 18 years.

Exclusion Criteria:

  • No exclusion criteria are expected apart from patients' refusal to participate in the study.

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): NCT04526405


Locations
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Italy
ASST Monza - Ospedale San Gerardo
Monza, MB, Italy, 20900
Sponsors and Collaborators
University of Milano Bicocca
Publications of Results:
Valenti L, Bergna A, Pelusi S, Facciotti F, Lai A, Tarkowski M, Berzuini A, Caprioli F, Santoro L, Baselli G, Della Ventura C, Erba E, Bosari S, Galli M, Zehender G, Prati D. SARS-CoV-2 seroprevalence trends in healthy blood donors during the COVID-19 Milan outbreak. medRxiv doi.org/10.1101/2020.05.11.20098442.

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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT04526405    
Other Study ID Numbers: ThalaCoV
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020

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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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Thalassemia
beta-Thalassemia
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hemoglobinopathies
Genetic Diseases, Inborn