COVID-19MICONCT04448743
Role of Microparticles in Covid-19 Infection
An observational study of COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Blood sample
- How many people
- 189 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2020to 4 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Covid-19 patients * patients with coronary artery disease * healthy volunteers
Who may be able to join
- 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
Who cannot join
- Significant comorbidities (active cancer, auto-immune diseases…)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Blood sample
- Keywords
- microparticles, microvesicles, vessel, vasculature, endothelium, coagulation, thrombosis
- Medical subject headings
- COVID-19, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
20 Ml blood sample
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 patients | Not described Receives: Other: Blood sample | |
| patients with coronary artery disease | Not described Receives: Other: Blood sample | |
| healthy volunteers | Not described Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western blot measurement of ACE2 receptor expression in porcine cells
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start2 Jul 2020
- Primary completion4 Oct 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448743
- Sponsor's protocol ID
- 7829
- Acronym
- MICO
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2020
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Circulating Microparticles in Covid-19 Infection
- ClinicalTrials.gov ID
- NCT04448743
- Acronym / sponsor ID
- MICO / 7829
- Conditions
- COVID-19
- Keywords
- microparticles, microvesicles, vessel, vasculature, endothelium, coagulation, thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 26 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Covid-19 patients | – | Other: Blood sample |
| patients with coronary artery disease | – | Other: Blood sample |
| healthy volunteers | – | Other: Blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Covid-19 patients * patients with coronary artery disease * healthy volunteers
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Significant comorbidities (active cancer, auto-immune diseases…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample20 Ml blood sample | Other | Covid-19 patients, healthy volunteers, patients with coronary artery disease |
Primary outcome
Western blot measurement of ACE2 receptor expression in porcine cells
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western blot measurement of ACE2 receptor expression in porcine cells (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.