SARS-CoV2 vaccination and activation of the clotting system

Phase 1

• Conditions: Coronavirus disease 2019 and thromboembolism; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-001655-13-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-24
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- adult patients (age > 18 years)
- obtained written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- patients with Down syndrome
- patients with known coagulation disorders
- patients on anticoagulants (vitamin K antagonist, low-molecular weight heparin or direct oral anticoagulants)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To explore the change in circulating biomarkers of activation of the coagulation system before and after SARS-CoV2 vaccination (AstraZeneca).;Secondary Objective: To explore the change in inflammatory cytokines before and after SARS-CoV2 vaccination (AstraZeneca).;Primary end point(s): The primary outcome is the presence of coagulation factor-inhibitor complexes above detection levels in peripheral blood:<br>- TAT (Thrombin Antithrombin complex)<br>- Pka:C1Inhibitor<br>- FXIa:a1AT<br>- FXIa:C1 Inhibitor<br>- FXIa:AT<br>- FIXa:AT<br>- FVIIa:AT;Timepoint(s) of evaluation of this end point: 24 hours and 48 hours after vaccination with COVID-19 Vaccine AstraZeneca

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary parameters are:<br>- D-dimer and inflammatory cytokines (TNF-alpha and IL-6);Timepoint(s) of evaluation of this end point: 24 hours and 48 hours after vaccination with COVID-19 Vaccine AstraZeneca