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ID
Source
Brief title
Health condition
COVID-19
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of endothelial surface in the blood-vessel-on-chip model that is covered by platelets and fibirn ("clotting") upon treatment with COVID-19 patient plasma. Coverage in the blood-vessel-on-chip will be measured by fluorescence microscopy.
Secondary outcome
Several measurements in the patient plasma:
- d-dimer level
- thrombin-antithrombin complexes (TAT)
- cytokine levels ((IL-1β, IL-6, and TNF-α)
- Markers of neutrophil extracellular traps (NETs) using ELISA:
a) Myeloperoxidase (MPO)/DNA
b) Citrullinated histone H3
- Tissue factor (TF) expressing extracellular vesicles as measured by a TF-dependent factor Xa activity assay.
Background summary
Initial reports from China (Zhou et al. , Guan et al.) showed an increase of coagulation activation. These first reports showed:
- Higher d-dimer levels
- Medium prolonged prothrombin time
- Mild thrombocytopenia
During the first COVID wave in the months March and April, several reports showed a high incidence of the development of venous thromboembolism (VTE). For example, Middeldorp et al. showed a cumulative incidence of VTE at 21 days of follow-up was 42% (95% CI 30-54).
This protombotic state contributes in the clinical course of COVID-19 patients. For example, Whichman et al. show that thrombotic complications could lead to a severe clinical outcome in COVID-19 patients.
Despite the evidence that shows the presence of this relation between COVID-19 and coagulation complications, the specific interactions are not yet known.
Therefore we aim to develop an in-vitro model, Blood-vessel-on-chip, that can mimic COVID-19 related hypercoagulability. We also intend to use these models in evaluating new antithrombotic treatments.
Study objective
Blood-vessel-on-chip technology can mimic the hypercoagulability in COVID-19 patients.
Study design
The primary outcome will be measured using fluorescent microscopy.
The secondary outcome will be measured via several laboratory procedures, such as ELISA.
Intervention
Blood taking procedure (total amount of 22.1 mL blood)
Inclusion criteria
- Age of 18 years or older
- A suspected SARS-CoV-2 virus infection
- Need for oxygen supplementation
- CRP level > 50 mg/L
- D-dimer level > 0.5 mg/L
- Ability to provide written informed consent
Exclusion criteria
- History of venous thromboembolism
- Use of anticoagulant therapy at inclusion
- Known hereditary or acquired thrombophilia
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9211 |
| Other | METC AMC : METC 2020_256 |