Status:
COMPLETED
Effect of SARSCoV2 (COVID-19) Vaccination in Type 1 Diabetes (CoVaxT1D)
Lead Sponsor:
Paolo Fiorina, MD
Collaborating Sponsors:
ASST Fatebenefratelli Sacco
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
16+ years
Brief Summary
Given the high risk of severe SARS-CoV-2 infection, patients with T1D and T2D should represent a priority group to receive the SARS-CoV-2 vaccine. There are currently no studies on diabetic population...
Detailed Description
Since the beginning of the COVID-19 pandemic in March 2020, more than 160 million people have suffered from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, and more than 3 mill...
Eligibility Criteria
Inclusion
- Inclusion Criteria for patients with type 1 diabetes:
- age \>16
- History of type 1 diabetes
- previous blood test in search for SARSCoV2 antibodies
- willingness to provide informed consent
- Exclusion Criteria for patients with type 1 diabetes:
- age \<16 years
- Systemic infections
- Diabetic ketoacidosis in the past 6 weeks
- COVID-19 diagnosis in the previous 6 months
- Inclusion Criteria for non-diabetic subjects:
- age \>16
- No previous history of diabetes
- previous blood test in search for SARSCoV2 antibodies
- willingness to provide informed consent
- Exclusion Criteria for non-diabetic subjects:
- age \<16 years
- Systemic infections
- COVID-19 diagnosis in the previous 6 months
- Inclusion Criteria for patients with type 2 diabetes:
- age \>16
- History of type 2 diabetes but no evidence of autoantibodies
- previous blood test in search for SARSCoV2 antibodies
- willingness to provide informed consent
- Exclusion Criteria for patients with type 2 diabetes:
- age \<16 years
- Systemic infections
- COVID-19 diagnosis in the previous 6 months
Exclusion
Key Trial Info
Start Date :
March 31 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04905823
Start Date
March 31 2021
End Date
June 30 2022
Last Update
May 10 2023
Active Locations (1)
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1
ASST FBF-Sacco P.O. Sacco
Milan, MI, Italy, 20157