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Clinical Trials/EUCTR2021-001459-15-AT
EUCTR2021-001459-15-AT
Active, not recruiting
Phase 1

Immune response to COVID-19 Vaccination in people with Diabetes Mellitus - COVAC-DM study - COVAC-DM

Medical University of Graz0 sites161 target enrollmentMarch 22, 2021
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ConditionsType 1 Diabetes MellitusType 2 Diabetes MellitusTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsCOVID-19 Vaccine AstraZenecaComirnatyCOVID-19 vaccine ModernaCOVID-19 Vaccine Janssen

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Type 1 Diabetes MellitusType 2 Diabetes Mellitus
Sponsor
Medical University of Graz
Enrollment
161
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 22, 2021
End Date
June 24, 2022
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Medical University of Graz

Eligibility Criteria

Inclusion Criteria

  • •Inclusion criteria for Diabetes Mellitus Cohort
  • •\-Age between 18 and 80 years, both inclusive
  • •\-Planned COVID\-19 vaccination
  • •Cohort I (Diabetes mellitus Type 1, well controlled)
  • •Glycated haemoglobin levels HbA1c \=7\.5 %
  • •Cohort II (Diabetes mellitus Type 1, uncontrolled)
  • •Glycated haemoglobin levels HbA1c \>7\.5 %
  • •Cohort III (Diabetes mellitus Type 2, well controlled)
  • •Glycated haemoglobin levels HbA1c \=7\.5 %
  • •Cohort IV (Diabetes mellitus Type 2, uncontrolled)

Exclusion Criteria

  • •Exlcusion criteria for Diabetes Mellitus Cohort
  • •\-Active known malignancy within the last year excluding intraepithelial neoplasia of prostate, gastrointestinal tract and basalioma
  • •\-Pregnancy or intention of becoming pregnant; breastfeeding
  • •\-Immunosuppressive therapy
  • •\-Acute or chronic inflammatory disorder
  • •\-Alcohol abuse (more than 15 drinks / week)
  • •\-Any contraindication to the vaccine planned to receive as listed in the product characteristics
  • •\-Previous COVID\-19 vaccine or episode of COVID\-19

Outcomes

Primary Outcomes

Not specified

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