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

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ClinicalTrials.gov Identifier: NCT05036824
Recruitment Status : Recruiting
First Posted : September 8, 2021
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
K.Akinosoglou MD,PhD, University Hospital of Patras

Brief Summary:
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.

Condition or disease Intervention/treatment
Covid19 Hospitalization Drug: tinzaparin

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Intensive Dose Tinzaparin in Hospitalized COVID19 Patients
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : April 30, 2022

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 Name: Innohep




Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. 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).

  2. Length of hospital stay [ Time Frame: through study completion, an average of 6 months ]
    Evaluate the length of hospital stay (in days)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Hospitalized patients with COVID-19 infection administered thromboprophylaxis with tinzaparin
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05036824


Contacts
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Contact: Karolina Akinosoglou, MD,PhD +306977762897 akin@upatras.gr

Locations
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Greece
University Hospital of Patras Recruiting
Patras, Achaia, Greece, 26504
Contact: Karolina Akinosoglou, Ass. Prof.    +30 2610997254    akin@upatras.gr   
Evangelismos General Hospital Recruiting
Athens, Attica, Greece, 10676
Contact: George Marakomichelakis, M.D. Ph.D.         
Sub-Investigator: Christine Vadala, M.D. Ph.D.         
General Hopital Elpis Recruiting
Athens, Attica, Greece, 11522
Contact: Spyridon Savvanis, M.D. Ph.D         
University General Hospital of Ioannina Recruiting
Ioannina, Epirus, Greece, 45500
Contact: Haralampos ] Milionis, Ass. Prof.         
General Hospital of Kerkira "Ag. Irini" Recruiting
Korfu, Ionian Islands, Greece, 49100
Contact: Ilias Papanicolaou, M.D. Ph.D.         
General Hospital of Kozani "Mamatsio" Recruiting
Kozáni, Macedonia, Greece, 50100
Contact: Efthalia Randou, M.D. Ph.D.         
Genereal Hospital of Patras "Ag. Andreas" Recruiting
Patras, Peloponnese, Greece, 26335
Contact: George Efremidis, M.D. Ph.D.         
Sponsors and Collaborators
University Hospital of Patras
Investigators
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Principal Investigator: Karolina Akinosoglou, MD,PhD University Hospital of Patras
  Study Documents (Full-Text)

Documents provided by K.Akinosoglou MD,PhD, University Hospital of Patras:
Publications:
Bikdeli B, Madhavan MV, Jimenez D, Chuich T, Dreyfus I, Driggin E, Nigoghossian C, Ageno W, Madjid M, Guo Y, Tang LV, Hu Y, Giri J, Cushman M, Quéré I, Dimakakos EP, Gibson CM, Lippi G, Favaloro EJ, Fareed J, Caprini JA, Tafur AJ, Burton JR, Francese DP, Wang EY, Falanga A, McLintock C, Hunt BJ, Spyropoulos AC, Barnes GD, Eikelboom JW, Weinberg I, Schulman S, Carrier M, Piazza G, Beckman JA, Steg PG, Stone GW, Rosenkranz S, Goldhaber SZ, Parikh SA, Monreal M, Krumholz HM, Konstantinides SV, Weitz JI, Lip GYH; Global COVID-19 Thrombosis Collaborative Group, Endorsed by the ISTH, NATF, ESVM, and the IUA, Supported by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function. COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Jun 16;75(23):2950-2973. doi: 10.1016/j.jacc.2020.04.031. Epub 2020 Apr 17. Review.

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Responsible Party: K.Akinosoglou MD,PhD, Study Principal Investigator, University Hospital of Patras
ClinicalTrials.gov Identifier: NCT05036824    
Other Study ID Numbers: 18634/23-7-2021 pend. aprooval
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data can e available after publication of results to other researchers upon a reasonable request.

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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
Keywords provided by K.Akinosoglou MD,PhD, University Hospital of Patras:
SARS-CoV-2
Tinzaparin
LMWH
COVID-19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Tinzaparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action