CompletedNot Applicable

Analysis of the Coagulopathy Developed by COVID-19 Infected Patients

France175 participantsStarted 2020-04-28

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

28-day survival rate

Timeframe: 1 month

Absolute thrombin generation test latent period

Timeframe: Day 0

Relative thrombin generation test latent period compared to reference plasma

Timeframe: Day 0

Absolute thrombin generation test initial velocity

Timeframe: Day 0

Relative thrombin generation test initial velocity compared to reference plasma

Timeframe: Day 0

Relative thrombin generation test peak thrombin compared to reference plasma

Timeframe: Day 0

Absolute thrombin generation test peak thrombin

Timeframe: Day 0

Absolute thrombin generation test peak thrombin time

Trial details

NCT IDNCT04356950

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-02-14

View on ClinicalTrials.gov More Sepsis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

28-day survival rate

Timeframe: 1 month

Absolute thrombin generation test latent period

Timeframe: Day 0

Relative thrombin generation test latent period compared to reference plasma

Timeframe: Day 0

Absolute thrombin generation test initial velocity

Timeframe: Day 0

Relative thrombin generation test initial velocity compared to reference plasma

Timeframe: Day 0

Relative thrombin generation test peak thrombin compared to reference plasma

Timeframe: Day 0

Absolute thrombin generation test peak thrombin

Timeframe: Day 0

Absolute thrombin generation test peak thrombin time