Vaccine-induced immune thrombotic thrombocytopenia and thrombosis syndrome (VITT/TTS) after vaccination against SARS-CoV-2 (COVID-19)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47159
• EU PAS number:
  EUPAS45098
• Study ID:
  47159
• Official title and acronym:
  Vaccine-induced immune thrombotic thrombocytopenia and thrombosis syndrome (VITT/TTS) after vaccination against SARS-CoV-2 (COVID-19)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This is a prospective patient registry in which all subjects with clinically suspected VITT/TTS between day 4 and 30 after vaccination with an adenoviral vector-based COVID-19-vaccine in whom VITT is confirmed by a positive anti-PF4/heparin IgG ELISA and a positive PF4-enhanced platelet activation assay are enrolled. Patients will be followed for 12 months after the anti-PF4 antibody test becomes negative with maximal observation period until 12-2022. Regular blood samples will be obtained to follow the development of anti-PF4 antibodies, to follow the development of platelet activating PF4-dependent antibodies, to assess anti-PF4 antibody response to booster vaccination with an mRNA COVID-19-vaccine, to assess anti-PF4 antibody reactions towards vaccination with another vaccine, e. g. influenza vaccine, and to assess anti-PF4 antibody response to exposure to heparin. Safety will be assessed by reported AEs and SAEs occurring in close relationship to interventions performed by the treating physician, especially second or third dose of Covid-19 vaccine, vaccination with any other vaccine, or surgical interventions or heparin application. In addition to the development of titers in anti-PF4 antibodies and platelet-activating PF4-dependent antibodies three explorative analyses will be performed: 1. Characterization of the anti-PF4 antibodies, especially the anti-PF4 antibody concentration required to induce platelet activation and the glycosylation pattern of anti-PF4 antibodies. 2. The IgG subclass of anti-PF4 antibodies in VITT/TTS patients. 3. Whole genome wide analysis of VITT/TTS patients and comparison of their genome with the genome characteristics of the general population in a Northeast German cohort.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual: 01/09/2021

Study start date

Actual: 01/09/2021

Data analysis start date

Actual: 01/10/2021

Date of interim report, if expected

Planned: 18/01/2022

Actual: 18/01/2023

Date of final study report

Planned: 18/01/2023

Actual: 20/03/2023

Sources of funding

EMA

Study protocol

Initial protocol

Study protocol Version 4.2 (002)

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

The study is registered at the German Clinical Trials Register: DRKS00025738