COVID-19COVID'HEMOSNCT04367662
Study of the Vascular Compartment and Hypercoagulability During Coronavirus Infection COVID-19
A study testing blood sampling in people with COVID-19, run by University Hospital, Rouen at 1 site in France.
Trial summary
Coronavirus COVID-19 is an emerging virus also called Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Eighty percent of patients are poor or asymptomatic. However, there are major respiratory complications for some patients, requiring intensive care hospitalization and possibly leading to death in 5% of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2020to 14 May 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any adult patient admitted to Rouen University Hospital for documented SARS-Cov-2 infection (PCR Test or CT scan)
- Patient who accept to participate to research after reading the information note
- Patient affiliated with Social Security
Who cannot join
- Patient under protective guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Coronavirus COVID-19 is an emerging virus also called Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Eighty percent of patients are poor or asymptomatic. However, there are major respiratory complications for some patients, requiring intensive care hospitalization and possibly leading to death in 5% of cases. One of the hypotheses put forward is that much of the pathophysiology is due to endothelial dysfunction associated with disseminated intravascular coagulation.
The covid-19 pathology could induce coagulation impairment as observed during sepsis. An increase in D-dimer levels during covid-19 disease is itself associated with excess mortality. While D-dimers are highly sensitive, they are not specific for clotting activity. They may be increased in many other circumstances, particularly in inflammation.
Read more
On the other hand, the infection stimulates the release of extracellular vesicles. These vesicles, of multiple cellular origin, are an actor of vascular homeostasis, and participate in the state of hyperactivation of coagulation. They have a major role in the prothrombotic state and the development of coagulopathy associated with sepsis.
The aim of our monocentric prospective study would be to study early and more specific markers of hypercoagulability and markers of routine endothelial dysfunction, as soon as the patient is hospitalized, in order to predict the risk of hospitalization in intensive care.
- Conditions
- COVID-19
- Being tested
- blood sampling
- Keywords
- Hemostasis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingProcedure or surgery
blood sampling in hospitalized patient for COVID-19 infection
| Study group | Role | What they receive |
|---|---|---|
| Patient with COVID-19 infection | Experimental | Patient with COVID-19 infection hospitalized in a COVID unit Receives: Procedure: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical worsening (yes/no) of the patient during hospitalization
Measured: in the 15 days from admission
D-DIMERS plasma levels in blood
Biological analysis using initial blood sampling
Measured: 1 hour after admission
Fibrin monomers plasma levels in blood
Biological analysis using initial blood sampling
Measured: 1 hour after admission
Antithrombin plasma levels in blood
Biological analysis using initial blood sampling
Measured: 1 hour after admission
Prothrombin Fragment 1 plasma levels in blood
Biological analysis using initial blood sampling
Measured: 1 hour after admission
Prothrombin Fragment 2 plasma levels in blood
Biological analysis using initial blood sampling
Measured: 1 hour after admission
Thrombin generation test plasma levels in blood
Biological analysis using initial blood sampling
Measured: 1 hour after admission
Microvesicles of platelet plasma levels in blood
Biological analysis using initial blood sampling
Measured: 1 hour after admission
Cross-linked platelets plasma levels in blood
Biological analysis using initial blood sampling
Measured: 1 hour after admission
Willebrand Factor plasma levels in blood
Biological analysis using initial blood sampling
Measured: 1 hour after admission
Factor VIII plasma levels in blood
Biological analysis using initial blood sampling
Measured: 1 hour after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start9 Apr 2020
- Primary completion14 May 2020
- Study completion14 May 2020
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, RouenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul BILLOIR, pharmacist, Principal investigator, University Hospital, RouenVéronique LE CAM, MD, Study director, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367662
- Sponsor's protocol ID
- 2020/0104/OB
- Acronym
- COVID'HEMOS
- Status last verified
- Jun 2020
- First submitted
- 16 Apr 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Vascular Compartment and Hypercoagulability During Coronavirus Infection COVID-19
- ClinicalTrials.gov ID
- NCT04367662
- Acronym / sponsor ID
- COVID'HEMOS / 2020/0104/OB
- Conditions
- COVID-19
- Keywords
- Hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 29 Apr 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.
Coronavirus COVID-19 is an emerging virus also called Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Eighty percent of patients are poor or asymptomatic. However, there are major respiratory complications for some patients, requiring intensive care hospitalization and possibly leading to death in 5% of cases. One of the hypotheses put forward is that much of the pathophysiology is due to endothelial dysfunction associated with disseminated intravascular coagulation.
The covid-19 pathology could induce coagulation impairment as observed during sepsis. An increase in D-dimer levels during covid-19 disease is itself associated with excess mortality. While D-dimers are highly sensitive, they are not specific for clotting activity. They may be increased in many other circumstances, particularly in inflammation.
On the other hand, the infection stimulates the release of extracellular vesicles. These vesicles, of multiple cellular origin, are an actor of vascular homeostasis, and participate in the state of hyperactivation of coagulation. They have a major role in the prothrombotic state and the development of coagulopathy associated with sepsis.
The aim of our monocentric prospective study would be to study early and more specific markers of hypercoagulability and markers of routine endothelial dysfunction, as soon as the patient is hospitalized, in order to predict the risk of hospitalization in intensive care.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with COVID-19 infection | Experimental | Procedure: blood samplingPatient with COVID-19 infection hospitalized in a COVID unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any adult patient admitted to Rouen University Hospital for documented SARS-Cov-2 infection (PCR Test or CT scan)
- Patient who accept to participate to research after reading the information note
- Patient affiliated with Social Security
Key exclusion criteria (1 listed)
- Patient under protective guardianship or curatorship
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 samplingblood sampling in hospitalized patient for COVID-19 infection | Procedure or surgery | Patient with COVID-19 infection |
Primary outcome
Clinical worsening (yes/no) of the patient during hospitalization
Time frame: in the 15 days from admission
D-DIMERS plasma levels in blood
Time frame: 1 hour after admission
Biological analysis using initial blood sampling
Fibrin monomers plasma levels in blood
Time frame: 1 hour after admission
Biological analysis using initial blood sampling
Antithrombin plasma levels in blood
Time frame: 1 hour after admission
Biological analysis using initial blood sampling
Prothrombin Fragment 1 plasma levels in blood
Time frame: 1 hour after admission
Biological analysis using initial blood sampling
Prothrombin Fragment 2 plasma levels in blood
Time frame: 1 hour after admission
Biological analysis using initial blood sampling
Thrombin generation test plasma levels in blood
Time frame: 1 hour after admission
Biological analysis using initial blood sampling
Microvesicles of platelet plasma levels in blood
Time frame: 1 hour after admission
Biological analysis using initial blood sampling
Cross-linked platelets plasma levels in blood
Time frame: 1 hour after admission
Biological analysis using initial blood sampling
Willebrand Factor plasma levels in blood
Time frame: 1 hour after admission
Biological analysis using initial blood sampling
Factor VIII plasma levels in blood
Time frame: 1 hour after admission
Biological analysis using initial blood sampling
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 9 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Paul BILLOIR, pharmacist principal investigator
University Hospital, Rouen
Véronique LE CAM, MD study director
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with COVID-19, run by University Hospital, Rouen 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 3 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 9 Jun 2020. 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?
Clinical worsening (yes/no) of the patient during hospitalization (time frame: in the 15 days from admission). The study lists 11 primary outcomes in all. 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 9 Jun 2020.