Intensive Dose Tinzaparin in Hospitalized COVID-19 Patients (INTERACT)

September 6, 2021 updated by: K.Akinosoglou MD,PhD, University Hospital of Patras

Intensive Dose Tinzaparin in Hospitalized COVID19 Patients

The primary objective of this study is to evaluate the current management approach with "intermediate" or "therapeutic" doses of tinzaparin for thromboprophylaxis in hospitalized patients, non on ICU organ support, with confirmed COVID-19.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A prothrombotic state, attributable to a cytokine storm induced by severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) and leading to activation of the coagulation cascade, is a recognized feature of Coronavirus disease 2019 (COVID-19) infection. This can manifest in venous thromboembolism (VTE), arterial thrombosis events (ATE), and disseminated intravenous coagulation (DIC) and coagulopathy are reflective of more severe disease and adverse prognosis. A significant number of patients with COVID-19 require single or multiple organ support on the Intensive Care Unit (ICU), estimated to be between 12 and 17% of patients. with the reported mortality in these cohorts between 25 and 40%.

International guidelines recommend that hospitalized patients with COVID-19 should receive pharmacological prophylaxis against VTE, in the absence of contraindications. With respect to how VTE prophylaxis is achieved, Low Molecular Weight Heparins (LMWH), in addition to their well-known anticoagulant properties, appear to have additional antiviral and anti-inflammatory effects that may be potentially beneficial in hospitalized COVID-19 patients.

Though international and national guidelines state that all hospitalized patients with COVID-19 should receive pharmacologic thromboprophylaxis, the rising incidence of thrombotic complications in COVID-19 patients has led a lot of hospitals to adopt the strategy of increasing the dose of anticoagulation for prophylaxis to 'intermediate' or "therapeutic" doses using a risk-adapted strategy with increased doses administration based on factors associated with increased risk; clinicians weigh the benefits and risks of therapeutic anticoagulation in terms of thrombosis and major bleeding risk for individual patients.

Additionally, LMWHs have different physicochemical characteristics as a result of the diverse methods of their manufacturing. The variations in molecular composition and pharmacological properties of LMWHs are reflected in differences in their clinical efficacy and safety. Each LMWH should, therefore, be considered as a unique substance. Tinzaparin is the only LMWH known that is prepared by enzymatic hydrolysis with heparinase. Due to its preparation method, tinzaparin has distinct properties than other LMWHs including and not limited to: higher Anti-IIa activity and Anti-Xa/Anti-IIa activity ratio, the higher release of Tissue Factor Pathway Inhibitor (TFPI), less dependence from renal function for its clearance, and more complete neutralization from its antidote, if needed. Due to the key role of increased Thrombin generation (IIa) and Tissue factor (TF) pathway activation in COVID-19-associated thrombosis , special properties of tinzaparin in Anti-IIa activity and TFPI production and release from endothelial cells, as well as significant effects of TFPI in various vascular, inflammatory, cardiovascular, hematological and oncological disorders, tinzaparin could have an expanded role beyond its well-known anticoagulant function.

The purpose of this study is to evaluate the overall clinical effectiveness and safety of 'intermediate' or "therapeutic" doses of anticoagulation with tinzaparin administered for thromboprophylaxis in COVID-19 patients with moderate disease severity during hospitalization in Greek hospitals.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Karolina Akinosoglou, MD,PhD
  • Phone Number: +306977762897
  • Email: akin@upatras.gr

Study Locations

  • Greece
    • Achaia
      • Patras, Achaia, Greece, 26504
        • Recruiting
        • University Hospital of Patras
        • Contact:
          • Karolina Akinosoglou, Ass. Prof.
          • Phone Number: +30 2610997254
          • Email: akin@upatras.gr
    • Attica
      • Athens, Attica, Greece, 10676
        • Recruiting
        • Evangelismos General Hospital
        • Contact:
          • George Marakomichelakis, M.D. Ph.D.
        • Sub-Investigator:
          • Christine Vadala, M.D. Ph.D.
      • Athens, Attica, Greece, 11522
        • Recruiting
        • General Hopital Elpis
        • Contact:
          • Spyridon Savvanis, M.D. Ph.D
    • Epirus
      • Ioannina, Epirus, Greece, 45500
        • Recruiting
        • University General Hospital of Ioannina
        • Contact:
          • Haralampos ] Milionis, Ass. Prof.
    • Ionian Islands
      • Korfu, Ionian Islands, Greece, 49100
        • Recruiting
        • General Hospital of Kerkira "Ag. Irini"
        • Contact:
          • Ilias Papanicolaou, M.D. Ph.D.
    • Macedonia
      • Kozáni, Macedonia, Greece, 50100
        • Recruiting
        • General Hospital of Kozani "Mamatsio"
        • Contact:
          • Efthalia Randou, M.D. Ph.D.
    • Peloponnese
      • Patras, Peloponnese, Greece, 26335
        • Recruiting
        • Genereal Hospital of Patras "Ag. Andreas"
        • Contact:
          • George Efremidis, M.D. Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hospitalized patients with COVID-19 infection administered thromboprophylaxis with tinzaparin

Description

Inclusion Criteria

  1. Patients admitted to hospital with COVID-19, PCR+ SARS-CoV-2 infection (from any specimen) administered thromboprophylaxis with tinzaparin in intermediate or therapeutic dose
  2. Age ≥ 18 years
  3. Signed informed consent

Exclusion Criteria

  1. Patients admitted to ICU with COVID-19, PCR+ SARS-CoV-2 infection (from any specimen)
  2. Age < 18 years
  3. Pregnancy
  4. Current diagnosis or suspicion of pulmonary thromboembolism or deep vein thrombosis
  5. Progression to death was imminent and inevitable within 24 hours from the admission, irrespective of the provision of treatments
  6. Not signed informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 patients

Patients admitted to hospital with COVID-19, PCR+ SARS-CoV-2 infection administered thromboprophylaxis with tinzaparin.

Dosage: intermediate or therapeutic dose Frequency of tinzaparin administration: once daily Duration: Unknown
Drug: tinzaparin
Daily tinzaparin administration: 8000 - 14000 Anti-Xa IU
Other Names:
  • Innohep

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of thrombotic events
Time Frame: through study completion, an average of 6 months
Evaluate the incidence of thrombotic events: total & per type e.g. PE, DVT, symptomatic, incidental, proximal, distant etc. (Measured as percentage of events in relation to the study population)
through study completion, an average of 6 months
Incidence of bleeding events
Time Frame: through study completion, an average of 6 months
Evaluate τηε ιncidence of bleeding events (total & per type e.g. Major, CRNMB and minor) (Measured as percentage of events in relation to the study population)
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WHO progression scale
Time Frame: through study completion, an average of 6 months
Evaluate the patients in relation to World Health Organization (WHO) progression scale (range from 0 (healthy) to 10 (death); values below or equal to 5 correspond to the absence of any oxygen supply beside nasal or facial mask).
through study completion, an average of 6 months
Length of hospital stay
Time Frame: through study completion, an average of 6 months
Evaluate the length of hospital stay (in days)
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Patras

Investigators

  • Principal Investigator: Karolina Akinosoglou, MD,PhD, University Hospital of Patras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

March 31, 2022

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

August 13, 2021

First Submitted That Met QC Criteria

September 6, 2021

First Posted (Actual)

September 8, 2021

Study Record Updates

Last Update Posted (Actual)

September 8, 2021

Last Update Submitted That Met QC Criteria

September 6, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18634/23-7-2021 pend. aprooval

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data can e available after publication of results to other researchers upon a reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on tinzaparin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe