Role of Microparticles in Covid-19 Infection (MICO)

June 15, 2022 updated by: University Hospital, Strasbourg, France

Role of Circulating Microparticles in Covid-19 Infection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

189

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67000
        • Olivier MOREL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Covid-19 patients
  • patients with coronary artery disease
  • healthy volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy volunteers
Other: Blood sample
20 Ml blood sample
patients with coronary artery disease
Other: Blood sample
20 Ml blood sample
Covid-19 patients
Other: Blood sample
20 Ml blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Western blot measurement of ACE2 receptor expression in porcine cells
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2020

Primary Completion (Actual)

October 4, 2021

Study Completion (Actual)

October 4, 2021

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 25, 2020

First Posted (Actual)

June 26, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2022

Last Update Submitted That Met QC Criteria

June 15, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7829

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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