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Sars-CoV2Phase 4COV-ENOXNCT04520620

Concentration-effect Relationship of Enoxaparin for Thromboembolic Prevention

A Phase 4 study testing Lovenox 40 MG in 0.4 mL Prefilled Syringe and Ultrasound of the lower limbs in people with Sars-CoV2, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Patients with COVID-19 have special demographic characteristics including thromboembolic risk factors . The pharmacokinetics of enoxaparin administered subcutaneously in the intensive care unit patient are not described. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sars-CoV2
What is being tested?
Lovenox 40 MG in 0.4 mL Prefilled Syringe and Ultrasound of the lower limbs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
4 sitesFrance
Study dates
2 May 2020to 10 Jul 2020
Phase
Phase 4
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

  • Aged > 18 ans
  • SARS-CoV-2 infected intensive care unit patients
  • Diagnosis of SARS-CoV-2 respiratory infection was made with a nasopharyngeal swab or a deep respiratory specimen.
  • Patient receiving enoxaparin treatment as part of care or as part of a clinical trial for the prevention or treatment of thromboembolic venous disease.
  • Patient affiliated or entitled to a social security scheme

Who cannot join

  • Creatinine clearance according to Cockcroft and Gault <30ml/min.
  • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWHs)
  • History of immune-mediated heparin-induced thrombocytopenia (HIT) in the last 100 days or in the presence of circulating antibodies
  • Active clinically significant bleeding or a condition associated with a high risk of bleeding, such as a recent hemorrhagic stroke, gastrointestinal ulcer, the presence of a malignant tumour at high risk of bleeding, recent brain, spinal or ophthalmologic surgery, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysm or major intrarachidian or intracerebral vascular abnormalities.
  • Spinal, epidural or locoregional anaesthesia or anaesthesia when enoxaparin sodium is used for curative treatment within the previous 24 hours

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Groupement Hospitalier des portes de Province

    Montélimar

  • Centre Hospitalier de Roanne

    Roanne

  • CHU de Saint-Etienne

    Saint-Etienne

  • Clinique Mutualiste

    Saint-Etienne

Other trials in France

About this study

Official title: Evaluation of the Concentration-effect Relationship of Enoxaparin for Thromboembolic Prevention in COVID-19 Intensive Unit Care Patients.

Patients with COVID-19 have special demographic characteristics including thromboembolic risk factors .

The pharmacokinetics of enoxaparin administered subcutaneously in the intensive care unit patient are not described.

Finally, given the lack of knowledge on the pharmacokinetic/pharmacodynamic properties of enoxaparin in intensive care unit patients infected with SARS-CoV-2, we propose to conduct a prospective multicenter cohort study to collect the biological data necessary for its study.

Read the detailed description

D-dimers greater than 1 μg/mL are a prognostic factor for 28-day mortality (odds ratio=18, 2-128). The use of preventive doses of enoxaparin (4,000 to 6,000 anti-Xa per day) or unfractionated heparin (10,000 to 15,000 IU per day) has been associated with a reduction in mortality of approximately one-third in patients with D-dimer levels greater than 3 μg/mL or those with sepsis-induced coagulopathy (SIC (sepsis-induced coagulopathy) score > 4)

For the intensive care unit patient, the preventive enoxaparin dosages were increased to 4,000 anti-Xa IU twice daily and to 6,000 anti-Xa IU twice daily if the patient weighs more than 120 kg. Curative treatment is even proposed in cases of marked inflammatory syndrome and/or hypercoagulability (e.g. fibrinogen > 8 g/L or D-Dimer > 3 μg/mL or 3000 ng/mL) even without symptomatic thrombosis.

Given the lack of data on the use of these high "prophylactic" doses of enoxaparin, it is proposed that anti-Xa activity be monitored after the 3rd injection, and then regularly in the event of renal failure (because LMWHs are renally eliminated), to look for overdosage exposing a higher risk of bleeding. It is also proposed to regularly monitor (at least every 48 hours) the hemostasis of patients in search of multivisceral failure, or of coagulopathy of consumption which will require a re-evaluation of the heparin therapy dosage, these events being associated with an increased risk of haemorrhage.

Conditions
Sars-CoV2
Being tested
Lovenox 40 MG in 0.4 mL Prefilled Syringe, Ultrasound of the lower limbs
Keywords
enoxaparin, intensive care unit, pharmacokinetics, SARS-Co-V-2, Lovenox

What participants receive

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

  • Lovenox 40 MG in 0.4 mL Prefilled SyringeDrug

    Also called enoxaparin

    Patients with a high thrombotic risk:

    In patients with a BMI included between < 30 kg/m² and > 30 kg/m² without added thrombotic risk factor:

    • Enoxaparin 40 milligrams, (4,000 IU) twice daily subcutaneously (SC) for the entire duration of the intensive care hospitalization
    • if weight > 120 kg, enoxaparin 60 milligrams (6000 IU) twice daily subcutaneously for the entire duration of the intensive care hospitalization

    Patients with a very high thrombotic risk:

    In patients with a BMI > 30 kg/m2 with added thrombotic risk factor (active cancer, recent personal history of thromboembolic event), or if iterative or unusual catheter thromboses, or if marked inflammatory syndrome and/or hypercoagulability (e.g. fibrinogen > 8 g/L or D-Dimer > 3 μg/ml or 3000 ng/ml)

    • Enoxaparin sodium curative at a dose of 100 IU/kg/12h subcutaneously (SC) not to exceed a dose of 100 mg/12 hours

  • Ultrasound of the lower limbsDevice

    A 4-point compression ultrasound will be performed. In case of suspicion, an angiologist will perform to check the absence of legs thrombosis.

Study groups in NCT04520620
Study groupRoleWhat they receive
enoxaparin treatmentExperimentalPatients infected by SARS-CoV-2 in intensive care unit with enoxaparin treatment will be included. They will have enoxaparin pharmacokinetic and ultrasound of the lower limbs at 7, 14 and 21 days after inclusion.
Receives: Drug: Lovenox 40 MG in 0.4 mL Prefilled Syringe; Device: Ultrasound of the lower limbs

What is being measured

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

  1. Measure of anti-Xa activity

    Measure of anti-Xa activity by chromogenic method.

    Measured: Up to 1 month

Secondary outcomes (6)

  1. Analysis of hemorrhagic risk

    Hemorrhagic risk is composite of :

    • Major haemorrhage as defined by the International Society on Thrombosis and Haemostasis (ISTH) definition
    • clinically significant haemorrhage

    Measured: Up to 1 month

  2. Venous thromboembolic events

    Venous thromboembolic events is composite of:

    • symptomatic or symptomatic proximal deep vein thrombosis
    • asymptomatic or symptomatic pulmonary embolism

    Measured: Up to 1 month

  3. Analysis individual patient characteristics by the biomarker of Kidney function

    Rate of creatinine.

    Measured: Up to 1 month

  4. Analysis individual patient characteristics by the biomarker of inflammation

    Biomarker of inflammation is composite of C-reactive protein (CRP) and inflammatory cytokines.

    Measured: Up to 1 month

  5. Analysis individual patient characteristics by the biomarker of coagulation

    Biomarker of coagulation is composite of fibrinogen and D-Dimers.

    Measured: Up to 1 month

  6. Demographic characteristics

    Analysis of weight, age, sex, height, presence of a high thrombotic risk factor (history of venous thrombotics, active cancer, invasive mechanical ventilation).

    Measured: Up to 1 month

Timeline

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

  1. First posted20 Aug 2020
  2. Study start2 May 2020
  3. Primary completion10 Jul 2020
  4. Study completion10 Jul 2020

Why it stopped: End of the COVID 19 epidemic in the region and decision to participate in a national study on the same subject (COVI-DOSE).

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04520620
Sponsor's protocol ID
20CH089
Other IDs
2020-001823-15
Acronym
COV-ENOX
Status last verified
Jul 2020
First submitted
22 Jul 2020
Last updated
20 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lovenox 40 MG in 0.4 mL Prefilled Syringe and Ultrasound of the lower limbs in people with Sars-CoV2, run by Centre Hospitalier Universitaire de Saint Etienne 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 20 Aug 2020. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Measure of anti-Xa activity (time frame: Up to 1 month). 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 NCT04520620.

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 20 Aug 2020.

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