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NCT04448743 Clinical Trial

Role of Microparticles in Covid-19 Infection

COVID-19 Clinical Trial

— MICO  

Official title:
Role of Circulating Microparticles in Covid-19 Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04448743
Other study ID # 7829
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2, 2020
Est. completion date October 4, 2021

Study information
Verified date June 2022
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Among the distinctive features of Covid-19, numerous reports have stressed the importance of vascular damages associated with coagulopathy onset. Microparticles (MPs) shed by apoptotic/stimulated cells are reliable markers of vascular damage released upon pro-inflammatory conditions and behave as active participants in the early steps of clot formation. In addition, MPs carry ACE1 and ACE2, the cell-entry receptor for SARS-Cov2 in the vasculature and up-regulate ACE1 expression in neighbouring endothelial cells. This may contribute to unopposed angiotensin II accumulation which further exacerbate tissue injury and promote both inflammation and thrombosis. The aim of the study is to evaluate the impact of circulating MPs on ACE2 expression, the cell-entry receptor for SARS-Cov2 on endothelial cells.

Description:

Circulating MPs will be isolated from Covid-19 patients with lupus anticoagulant, from coronary artery diseases patients and from healthy volunteers without cardiovascular risk factors. Quantification of MPs will be realized by prothrombinase assay. Primary endothelial cells (ECs) from porcine coronary artery or porcine pulmonary artery will be isolated and cultured. ECs will be exposed to circulating MPs. Phenotypical changes (ACE2 expression, cytoadhesins, cytokines, tissue factor expression) of ECs will be examined. Susceptibility of ECs to SARS-COV-2 infection will be determined.

Recruitment information / eligibility
Status Completed
Enrollment 189
Est. completion date October 4, 2021
Est. primary completion date October 4, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - COVID-19 patients: age > 18 yr - SARS-COV-2 infection within 12 months and positive lupus anticoagulant - Patients with cardiovascular risk factors: at least among - Hypertension, Dyslipidemia, Diabetes mellitus, obesity, smoker, Healthy volunteers Exclusion Criteria: - Significant comorbidities (active cancer, auto-immune diseases…)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood sample
20 Ml blood sample

Locations
Country Name City State
France Olivier MOREL Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Western blot measurement of ACE2 receptor expression in porcine cells Through study completion, an average of 1 year
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