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SepsisCOVID-TGTNCT04356950

Analysis of the Coagulopathy Developed by COVID-19 Infected Patients

An observational study of Sepsis and Blood Coagulation Disorders, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Increased D-dimers at admission of COVID-19 infected patients entering hospital due to a severe disease is a risk factor for death. Understanding this acquired coagulopathy is a prerequisite before specific interventional studies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis, Blood Coagulation Disorders, Thrombin
What is being tested?
Thrombin generation test assay and Fibrin generation markers assays
How many people
175 participants
Where
4 sitesFrance
Study dates
28 Apr 2020to 14 Feb 2022
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: Consecutive patients hospitalized for SARS-CoV-2 infection with symptomatology / severity requiring hospital treatment.

Who may be able to join

  • Patient with SARS-CoV-2 infection entering hospitalization with or without resuscitation
  • The patient (or their carer) must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan

Who cannot join

  • Pregnant or breastfeeding patient
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Thrombotic events during treatment: flare-up of venous thromboembolism, flare-up of atherothrombosis.
  • Long-term anticoagulant treatment (anti-vitamin K, direct oral anticoagulant).
  • Chronic anti-aggregation treatment.
  • Pre-existing constitutive or acquired known coagulation pathology: hemorrhagic diseases (thrombocytopenia, thrombocytopathy, hemophilia, von Willebrand's disease, hemorrhagiparous factor deficiency), and for thrombophilia (deficits in antithrombin, protein C or S , Factor V Leiden or Prothrombin 20201A mutation).

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • CHU de Bordeaux

    Bordeaux

  • CHU de Limoges

    Limoges

  • CHU de Montpellier

    Montpellier

  • CHU de Nimes

    Nîmes

Other trials in France

About this study

Official title: Analysis of the Coagulopathy Developed by COVID-19 Infected Patients: Thrombin Generation Potential in COVID-19 Infected Patients

Increased D-dimers at admission of COVID-19 infected patients entering hospital due to a severe disease is a risk factor for death. Understanding this acquired coagulopathy is a prerequisite before specific interventional studies. The study investigators aim to apply a normalized and automated thrombin generation test (TGT), developed for testing the thrombotic risk (triggered by 5 pM Tissue Factor, with a purified thrombomodulin (TM) challenge) and to study its association with survival.

Read the detailed description

Accumulating data describe, in COVID-19 severely infected patients necessitating hospitalized medical support, the development of an acquired coagulopathy, from a sepsis-induced coagulopathy to an overt-DIC, which is a strong risk factor for death. Understanding this coagulopathy is a prerequisite before specific interventional studies. Conventional coagulation tests, like prothrombin time PT and aPTT, only reflect 5% of the total thrombin generation and are insensitive to the patients' natural anticoagulants. The investigators thus wish to analyze the coagulopathy of SARS-CoV-2 using a global analytical test reflecting the full complexity of thrombin generation then inhibition, the thrombin generation test (TGT), in its version designed to analyze the thrombotic risk (initiation by an intermediate concentration of human Tissue: 5 pM), in its fully automated and standardized technical version. This test analyzes not only the generation of thrombin and its various informative phases (initiation phase, propagation phase culminating at the peak of formation, inhibition phase with natural anticoagulants) but also the capacity for an exogenous addition of purified thrombomodulin (TM), which quantifies the anticoagulant activity of the patient's protein C activated by thrombin, to inhibit this generation of thrombin.

The aim is to assay this TGT version in a centralized way, on the patients' plasma obtained at hospital admission, just after checking the positive COVID-19 testing , together with the traditional blood tests including platelet counts, PT, D-dimers (DDi) and soluble fibrin monomers (FMs). The various quantitative biological parameters describing the results of the TGT assay, together with relevant covariates, will be tested using multivariate analysis for their capacity to be risk factors for clinically-relevant qualitative outcomes.

Being tested
Thrombin generation test assay, Fibrin generation markers assays
Keywords
coagulation, survival, thrombin generation test
Medical subject headings
Sepsis, Blood Coagulation Disorders, Disseminated Intravascular Coagulation, COVID-19, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thrombin generation test assayOther

    lag time, initial velocity, time-to-peak, thrombin peak, total thrombin generation time, extrinsic thrombin potential (ETP). Crude quantitative values and relative values (%, by reference to the one obtained with an invariant reference plasma). Both without the addition of purified thrombomodulin (TM-) and with the addition of purified thrombomodulin (TM+). The ability of TM to inhibit thrombin generation will be calculated as follows: [ETP (%)(TM+) / ETP (%)(TM-)].

  • Fibrin generation markers assaysOther

    D-dimers (coagulation plus fibrinolysis), soluble fibrin monomers (coagulation only)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 28-day survival rate

    Death yes/no during hopstilization, 28 days after admittence

    Measured: 1 month

  2. Absolute thrombin generation test latent period

    Seconds; without (TM-) and with (TM+) purified thrombomodulin

    Measured: Day 0

  3. Relative thrombin generation test latent period compared to reference plasma

    %; without (TM-) and with (TM+) purified thrombomodulin

    Measured: Day 0

  4. Absolute thrombin generation test initial velocity

    nmol/s; without (TM-) and with (TM+) purified thrombomodulin

    Measured: Day 0

  5. Relative thrombin generation test initial velocity compared to reference plasma

    %; without (TM-) and with (TM+) purified thrombomodulin

    Measured: Day 0

  6. Relative thrombin generation test peak thrombin compared to reference plasma

    %; without (TM-) and with (TM+) purified thrombomodulin

    Measured: Day 0

  7. Absolute thrombin generation test peak thrombin

    nmol/L; without (TM-) and with (TM+) purified thrombomodulin

    Measured: Day 0

  8. Absolute thrombin generation test peak thrombin time

    Seconds; without (TM-) and with (TM+) purified thrombomodulin

    Measured: Day 0

  9. Relative thrombin generation test peak thrombin time compared to reference plasma

    %; without (TM-) and with (TM+) purified thrombomodulin

    Measured: Day 0

  10. Absolute thrombin generation test total thrombin generation time

    seconds; without (TM-) and with (TM+) purified thrombomodulin

    Measured: Day 0

  11. Relative thrombin generation test total thrombin generation time compared to reference plasma

    %; without (TM-) and with (TM+) purified thrombomodulin

    Measured: Day 0

  12. Absolute thrombin generation test endogenous thrombin potential

    Seconds; without (TM-) and with (TM+) purified thrombomodulin

    Measured: Day 0

  13. Relative thrombin generation test endogenous thrombin potential compared to reference plasma

    %; without (TM-) and with (TM+) purified thrombomodulin

    Measured: Day 0

Secondary outcomes (5)

  1. 3-month survival rate

    Death yes/no

    Measured: 3 months

  2. Transfer to intensive care unit during hospitalization

    Yes/no

    Measured: 3 months

  3. Thrombotic complication during hospitalization

    Yes/no (deep vein thrombosis, pulmonary embolism, atherothrombosis flare, arterial thrombosis)

    Measured: 3 months

  4. Plasma concentrations of D-dimers

    µg / L, assayed by automated enzyme linked fluorescent assay (Vidas® D-dimers Exclusion ™ II)

    Measured: Day 0

  5. Plasma concentrations of soluble fibrin monomers

    mg / L, measured by automated immunoagglutination (STA®-Liatest® FM)

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2020
  2. Study start28 Apr 2020
  3. Primary completion14 Feb 2022
  4. Study completion14 Feb 2022

Resources

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
Other
Time perspective
Prospective
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04356950
Sponsor's protocol ID
PHRC-I/2020/JCG-01
Other IDs
2020-A01068-31
Acronym
COVID-TGT
Status last verified
Sep 2022
First submitted
16 Apr 2020
Last updated
4 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gris JC, Guillotin F, Dos Santos TP, Chea M, Loubet P, Laureillard D, Sotto A, Muller L, Barbar SD, Roger C, Lefrant JY, Jung B, Klouche K, Mura T, Quere I, Perez-Martin A. Prognostic value of an automated thrombin generation assay in COVID-19 patients entering hospital: A multicentric, prospective observational study. Thromb Res. 2023 Feb;222:85-95. doi: 10.1016/j.thromres.2022.12.019. Epub 2023 Jan 2.

    PubMed 36608393

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis and Blood Coagulation Disorders, run by Centre Hospitalier Universitaire de Nīmes at 4 sites 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 7 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 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

28-day survival rate (time frame: 1 month). The study lists 13 primary outcomes in all. 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 NCT04356950, 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 4 Dec 2025.

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