COVID-19THROMBOCOVIDNCT04366752
Thrombo Embolic Events in Critical Care Patients With Covid-19 Serious Acute Pneumopathy
An observational study of COVID-19 and Pneumonia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. Complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- venous ultrasound and blood sample
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2020to 22 Sep 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: every patient hospitalized in CHU Amiens medical ICU with pneumonia due to COVID-19 infection
Who may be able to join
- patients hospitalized in medical ICU with pneumonia due to COVID-19 infection
Who cannot join
- patients< 18 years
Trial locations and contacts
1 site in 1 country.
About this study
The understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. Complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components. Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xa may increase inflammation by promoting the production of pro-inflammatory cytokines, chemokines, growth factors and adhesion molecules that lead to a procoagulant state amplifying the pathological process. Recent evidence supports inflammation as a common pathogenic contributor to both arterial and venous thrombosis, giving rise to the concept of inflammation-induced thrombosis.
Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk of thromboembolism. Very few data are available regarding the biological disorders of coagulation in these patients. Th purpose of this project is to analyze hemostasis and coagulation of patients with infection of COVID-19 and severe pneumonia.
- Conditions
- COVID-19, Pneumonia, ARDS, Hemostasis, Coagulation
- Being tested
- venous ultrasound, blood sample
- Keywords
- COVID-19, pneumonia, ARDS, venous ultrasound, hemostasis, coagulation
- Medical subject headings
- COVID-19, Pneumonia, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venous ultrasoundOther
Venous ultrasound will be performed on patients once a week, every week from the day of admission in ICU until the day of patient discharge
blood sampleOther
blood sample for coagulation and hemostasis analysis will be withdrawn from artery catheter from the day of admission in ICU until the day of patient discharge
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of thrombin time (in secondes) in Covid-19 patients with pneumonia admitted in ICU.
The reference range for the thrombin time is usually less than 20 seconds (ie, 15-19 seconds)
Measured: up to 6 weeks
Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
Measured: up to 6 weeks
Variation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
Variation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
Measured: up to 6 weeks
Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Covid-19 patients with pneumonia admitted in ICU.
Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Covid-19 patients with pneumonia admitted in ICU.
Measured: up to 6 weeks
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 start22 Apr 2020
- Primary completion22 Aug 2020
- Study completion22 Sep 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 Centre Hospitalier Universitaire, AmiensThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366752
- Sponsor's protocol ID
- PI2020_843_0036
- Acronym
- THROMBOCOVID
- Status last verified
- Mar 2023
- First submitted
- 27 Apr 2020
- Last updated
- 22 Mar 2023
- 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 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombo Embolic Events in Critical Care Patients With Covid-19 Serious Acute Pneumopathy
- ClinicalTrials.gov ID
- NCT04366752
- Acronym / sponsor ID
- THROMBOCOVID / PI2020_843_0036
- Conditions
- COVID-19, Pneumonia, ARDS, Hemostasis, Coagulation
- Keywords
- COVID-19, pneumonia, ARDS, venous ultrasound, hemostasis, coagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 22 Aug 2020 (actual)
- Study completion
- 22 Sep 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.
The understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. Complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components. Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xa may increase inflammation by promoting the production of pro-inflammatory cytokines, chemokines, growth factors and adhesion molecules that lead to a procoagulant state amplifying the pathological process. Recent evidence supports inflammation as a common pathogenic contributor to both arterial and venous thrombosis, giving rise to the concept of inflammation-induced thrombosis.
Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk of thromboembolism. Very few data are available regarding the biological disorders of coagulation in these patients. Th purpose of this project is to analyze hemostasis and coagulation of patients with infection of COVID-19 and severe pneumonia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- every patient hospitalized in CHU Amiens medical ICU with pneumonia due to COVID-19 infection
Key inclusion criteria (1 listed)
- patients hospitalized in medical ICU with pneumonia due to COVID-19 infection
Key exclusion criteria (1 listed)
- patients< 18 years
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 |
|---|---|---|
| venous ultrasoundVenous ultrasound will be performed on patients once a week, every week from the day of admission in ICU until the day of patient discharge | Other | – |
| blood sampleblood sample for coagulation and hemostasis analysis will be withdrawn from artery catheter from the day of admission in ICU until the day of patient discharge | Other | – |
Primary outcome
Variation of thrombin time (in secondes) in Covid-19 patients with pneumonia admitted in ICU.
Time frame: up to 6 weeks
The reference range for the thrombin time is usually less than 20 seconds (ie, 15-19 seconds)
Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
Time frame: up to 6 weeks
Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
Variation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
Time frame: up to 6 weeks
Variation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Covid-19 patients with pneumonia admitted in ICU.
Time frame: up to 6 weeks
Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Covid-19 patients with pneumonia admitted in ICU.
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 22 Mar 2023.
- 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.
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 and Pneumonia, run by Centre Hospitalier Universitaire, Amiens 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 1 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 22 Mar 2023. 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?
Variation of thrombin time (in secondes) in Covid-19 patients with pneumonia admitted in ICU. (time frame: up to 6 weeks). The study lists 4 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 22 Mar 2023.