Study identification

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

Contact details

Andreas Greinacher

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable