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Role of Microparticles in Covid-19 Infection (MICO)

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ClinicalTrials.gov Identifier: NCT04448743
Recruitment Status : Not yet recruiting
First Posted : June 26, 2020
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief 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.

Condition or disease Intervention/treatment
COVID-19 Other: Blood sample

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.

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Study Type : Observational
Estimated Enrollment : 175 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Circulating Microparticles in Covid-19 Infection
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Group/Cohort Intervention/treatment
Covid-19 patients Other: Blood sample
20 Ml blood sample

patients with coronary artery disease Other: Blood sample
20 Ml blood sample

healthy volunteers Other: Blood sample
20 Ml blood sample




Primary Outcome Measures :
  1. Western blot measurement of ACE2 receptor expression in porcine cells [ Time Frame: Through study completion, an average of 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Covid-19 patients
  • patients with coronary artery disease
  • healthy volunteers
Criteria

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…)
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04448743    
Other Study ID Numbers: 7829
First Posted: June 26, 2020    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
microparticles
microvesicles
vessel
vasculature
endothelium
coagulation
thrombosis
Additional relevant MeSH terms:
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Infection