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

NCT04526405 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2020-11-09

No results posted yet for this study

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%).

Conditions

  • Thalassemia Major
  • Covid19

Interventions

DIAGNOSTIC_TEST

SARS-CoV-2 S1/S2 IgG

SARS-CoV-2 S1/S2 IgG analysis

Sponsors & Collaborators

  • University of Milano Bicocca

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-14
Primary Completion
2020-11-03
Completion
2020-11-03

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04526405 on ClinicalTrials.gov