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

November 6, 2020 updated by: University of Milano Bicocca

Study on the Frequency of COVID-19 Antibodies in Patients With Hereditary Hematological Diseases Subject to Chronic Transfusion Support.

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%).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

INTRODUCTION 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.

These patients, as patients with chronic diseases, many of which also splenectomized, are generally considered to be at greater risk of infection and complications in the event of an infection.

However, preliminary studies in patients with thalassemia and sickle cell anemia do not seem to confirm these assumptions about the COVID-19 pandemic (Motta I et al, Hussain FA et al, Taher A et al). On the basis of these data, it was hypothesized that the chronic inflammatory background, the hemolytic and anemic status of these patients could have a favorable and protective influence on the risk of fatal COVID-19 infections (Roy NBA et al).

A recent study in the Milan area identified the positivity of anti-Covid-19 antibodies in 4.4-10.8% of asymptomatic donors (Valenti L et al).

TARGETS In this study, the presence of COVID-19 IgG antibodies will be assessed in all transfusion dependent patients affected by thalassemia, Blackfan-Diamond anemia, sickle cell anemia and other chronic anemias, related to the ASST-Monza Rare Disease Center, S. Gerardo and all residents in the provinces of Monza-Brianza, Como, Lecco, Varese and Milan. Of these patients, 15% experienced potentially suspect symptoms of infection, albeit mildly overall, but only 5 patients performed the nasal swab which tested positive in one case.

The study should be considered as a pilot and preliminary study since no data are available. The primary objective is to define the transfusion risk as a source of contact with the virus in patients subject to multiple transfusions (every 2-3 weeks for a total of about 300 units of blood used per month). Based on the results, further information on the exposure of these patients to COVID-19 infection may be obtained.

DESIGN This is a study with use of biological material. All patients suffering from hereditary transfusion anemias or who have undergone recurrent transfusion procedures belonging to the Rare Disease Center of ASST Monza will be enrolled in the study. The patients will be enrolled in the study when consent is obtained. A serum sample will be analyzed for anti-COVID-19 antibodies and if the result is positive, the nasal swab will be performed. If the outcome of the swab is positive, the patient must undergo quarantine and follow the national protocol. Only demographic data will be collected and only the value of antibodies to COVID-19 as biochemical data.

METHODS Serological test is based on the identification of COVID-19 antibodies (anti-s1 and -s2) by CLIA method. It has a high sensitivity (97.4%) and specificity (98.%). Although the test has a high concordance value (> 95%), it is not possible to consider if the positive subjects have neutralizing antibodies for the virus. In the case of a positive test, the molecular test for diagnostic confirmation is provided.

The analysis will be carried out at the ASST-Monza Microbiology Laboratory - S. Gerardo Hospital (Primary: Dr. Annalisa Cavallero) and an aliquot of serum will be kept at the Cytogenetics and Medical Genetics Laboratory for 1 year after the end of the study.

EXPECTED RESULTS Based on the few data available in Italy, the investigator foresees 5-10% of positive subjects.

SAMPLE SIZE AND STATISTICAL ANALYSIS All 81 transfusion dependent patients belonging to the Rare Disease Center of ASST-Monza, S. Gerardo Hospital will be included in the study and for this reason a formal calculation of sample size has not been performed.

The statistical analysis will be substantially descriptive and it will use appropriate central tendency and dispersion measures for quantitative variables, while absolute and relative frequencies will be used for qualitative variables. The estimates of the primary endpoint relating to the percentage of transfusion-dependent patients tested positive will be reported with their respective 95% confidence intervals.

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MB
      • Monza, MB, Italy, 20900
        • ASST Monza - Ospedale San Gerardo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive subjects
Time Frame: 2 months
On the basis of the few data available in Italy, the investigator foresees 5-10% of positive subjects.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2020

Primary Completion (Actual)

November 3, 2020

Study Completion (Actual)

November 3, 2020

Study Registration Dates

First Submitted

August 6, 2020

First Submitted That Met QC Criteria

August 24, 2020

First Posted (Actual)

August 25, 2020

Study Record Updates

Last Update Posted (Actual)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ThalaCoV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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