NCT04448743

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

July 2, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2021

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

1.3 years

First QC Date

June 22, 2020

Last Update Submit

June 15, 2022

Conditions

Keywords

microparticlesmicrovesiclesvesselvasculatureendotheliumcoagulationthrombosis

Outcome Measures

Primary Outcomes (1)

  • Western blot measurement of ACE2 receptor expression in porcine cells

    Through study completion, an average of 1 year

Study Arms (3)

Covid-19 patients

Other: Blood sample

patients with coronary artery disease

Other: Blood sample

healthy volunteers

Other: Blood sample

Interventions

20 Ml blood sample

Covid-19 patientshealthy volunteerspatients with coronary artery disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Significant comorbidities (active cancer, auto-immune diseases…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Olivier MOREL

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

COVID-19Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 26, 2020

Study Start

July 2, 2020

Primary Completion

October 4, 2021

Study Completion

October 4, 2021

Last Updated

June 16, 2022

Record last verified: 2022-06

Locations