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
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|
|Study Type :||Observational|
|Actual Enrollment :||63 participants|
|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|
- Diagnostic Test: SARS-CoV-2 S1/S2 IgG
SARS-CoV-2 S1/S2 IgG analysis
- 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
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
|ASST Monza - Ospedale San Gerardo|
|Monza, MB, Italy, 20900|