COVID-19 InfectionTHROMBOVIDNCT04359992
Study of Hemostasis in Case of Severe COVID-19
An observational study of COVID-19 Infection, run by University Hospital, Strasbourg, France.
Trial summary
The COVID-19 outbreak has led to a significant increase in the number of patients admitted to intensive care for respiratory distress. Early data indicate a particularly high risk of thrombotic risk to viral lung disease, particularly in the most severe patients, with a particularly high incidence of pulmonary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- Extra blood sample
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 17 Apr 2020to 1 May 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients hospitalized in intensive care for severe COVID-19 infection
Who may be able to join
- Adult patient (<18y)
- With a SARS-CoV-2 infection confirmed by RT-PCR
- Hospitalized in intensive care
Who cannot join
- Patients under guardianship/curator
- Anemia at 7 g/dL at inclusion
Trial locations and contacts
No sites are listed yet.
About this study
The COVID-19 outbreak has led to a significant increase in the number of patients admitted to intensive care for respiratory distress. Early data indicate a particularly high risk of thrombotic risk to viral lung disease, particularly in the most severe patients, with a particularly high incidence of pulmonary embolism. Catheter thrombosis and extra-renal purification filters are also abnormally common. These thrombotic complications could contribute to the mortality observed in this pathology. The introduction of early curative anticoagulation in the most severe patients has just been proposed by the perioperative hemostasis interest group
Biologically, a significant proportion of patients hospitalized in intensive care have a marked biological inflammatory syndrome, associated with signs of activation of clotting (a frank increase in D-dimers). The presence of circulating anticoagulants is common. Interestingly, thrombocytosis, normally observed in such inflammatory syndromes, is absent.
In this context, it seems legitimate to explore these patients from a hemostasis perspective to identify the factors that cause this thrombotic over-risk, in order to minimize the occurrence of these complications.
- Conditions
- COVID-19 Infection
- Being tested
- Extra blood sample
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra blood sampleOther
3 extra blood samples at day 0, 2 and 7
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet activation intensity with the occurrence of clinical thrombotic complications
Measured: Change of platelet activity from admission's day in intensive care unit to 2 days and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start17 Apr 2020 (estimated)
- Primary completion17 Apr 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 InfectionStudies 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
- 50 participants (estimated)
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
- NCT04359992
- Sponsor's protocol ID
- 7774
- Acronym
- THROMBOVID
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tacquard C, Mouriaux C, Delabranche X, Bourdon C, Eckly A, Magnenat S, Sattler L, Gachet C, Mertes PM, Hechler B, Mangin PH. Platelet dysfunction and thrombus instability in flow conditions in patients with severe COVID-19. Thromb Res. 2023 Jan;221:137-148. doi: 10.1016/j.thromres.2022.11.004. Epub 2022 Nov 8.
PubMed 36376109
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hemostasis in Case of Severe COVID-19
- ClinicalTrials.gov ID
- NCT04359992
- Acronym / sponsor ID
- THROMBOVID / 7774
- Conditions
- COVID-19 Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 17 Apr 2020 (estimated)
- Primary completion
- 17 Apr 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 24 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 COVID-19 outbreak has led to a significant increase in the number of patients admitted to intensive care for respiratory distress. Early data indicate a particularly high risk of thrombotic risk to viral lung disease, particularly in the most severe patients, with a particularly high incidence of pulmonary embolism. Catheter thrombosis and extra-renal purification filters are also abnormally common. These thrombotic complications could contribute to the mortality observed in this pathology. The introduction of early curative anticoagulation in the most severe patients has just been proposed by the perioperative hemostasis interest group
Biologically, a significant proportion of patients hospitalized in intensive care have a marked biological inflammatory syndrome, associated with signs of activation of clotting (a frank increase in D-dimers). The presence of circulating anticoagulants is common. Interestingly, thrombocytosis, normally observed in such inflammatory syndromes, is absent.
In this context, it seems legitimate to explore these patients from a hemostasis perspective to identify the factors that cause this thrombotic over-risk, in order to minimize the occurrence of these complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients hospitalized in intensive care for severe COVID-19 infection
Key inclusion criteria (3 listed)
- Adult patient (<18y)
- With a SARS-CoV-2 infection confirmed by RT-PCR
- Hospitalized in intensive care
Key exclusion criteria (2 listed)
- Patients under guardianship/curator
- Anemia at 7 g/dL at inclusion
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 |
|---|---|---|
| Extra blood sample3 extra blood samples at day 0, 2 and 7 | Other | – |
Primary outcome
Platelet activation intensity with the occurrence of clinical thrombotic complications
Time frame: Change of platelet activity from admission's day in intensive care unit to 2 days and 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 36376109Tacquard C, Mouriaux C, Delabranche X, Bourdon C, Eckly A, Magnenat S, Sattler L, Gachet C, Mertes PM, Hechler B, Mangin PH. Platelet dysfunction and thrombus instability in flow conditions in patients with severe COVID-19. Thromb Res. 2023 Jan;221:137-148. doi: 10.1016/j.thromres.2022.11.004. Epub 2022 Nov 8.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Infection, run by University Hospital, Strasbourg, 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 2 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: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles TACQUARD (369551608 ext. +33, charlesambroise.tacquard@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet activation intensity with the occurrence of clinical thrombotic complications (time frame: Change of platelet activity from admission's day in intensive care unit to 2 days and 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359992, which also lists 1 linked publication.
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 24 Apr 2020.