Intensive Dose Tinzaparin in Hospitalized COVID-19 Patients

NCT05036824 | Unknown FDA Drug

• 1 other identifier: 18634/23-7-2021 pend. aprooval
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 7

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.

Conditions

Covid19; Hospitalization

Keywords

SARS-CoV-2; Tinzaparin; LMWH; COVID-19

Outcome Measures

Primary Outcomes (2)

• Incidence of thrombotic events

  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

  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 Outcomes (2)

• WHO progression scale

  through study completion, an average of 6 months

• Length of hospital stay

  through study completion, an average of 6 months

Study Arms (1)

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

Interventions

tinzaparin DRUG

Daily tinzaparin administration: 8000 - 14000 Anti-Xa IU

Also known as: Innohep

COVID-19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospitalized patients with COVID-19 infection administered thromboprophylaxis with tinzaparin

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (7)

University Hospital of Patras

Pátrai, Achaia, 26504, Greece

RECRUITING

Evangelismos General Hospital

Athens, Attica, 10676, Greece

RECRUITING

General Hopital Elpis

Athens, Attica, 11522, Greece

RECRUITING

University General Hospital of Ioannina

Ioannina, Epirus, 45500, Greece

RECRUITING

General Hospital of Kerkira "Ag. Irini"

Corfu, Ionian Islands, 49100, Greece

RECRUITING

General Hospital of Kozani "Mamatsio"

Kozani, Macedonia, 50100, Greece

RECRUITING

Genereal Hospital of Patras "Ag. Andreas"

Patras, Peloponnese, 26335, Greece

RECRUITING

Related Publications (18)

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  PMID: 32291954 BACKGROUND

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  PMID: 32178769 BACKGROUND

• Grasselli G, Pesenti A, Cecconi M. Critical Care Utilization for the COVID-19 Outbreak in Lombardy, Italy: Early Experience and Forecast During an Emergency Response. JAMA. 2020 Apr 28;323(16):1545-1546. doi: 10.1001/jama.2020.4031. No abstract available.

  PMID: 32167538 BACKGROUND

• Docherty AB, Harrison EM, Green CA, Hardwick HE, Pius R, Norman L, Holden KA, Read JM, Dondelinger F, Carson G, Merson L, Lee J, Plotkin D, Sigfrid L, Halpin S, Jackson C, Gamble C, Horby PW, Nguyen-Van-Tam JS, Ho A, Russell CD, Dunning J, Openshaw PJ, Baillie JK, Semple MG; ISARIC4C investigators. Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study. BMJ. 2020 May 22;369:m1985. doi: 10.1136/bmj.m1985.

  PMID: 32444460 BACKGROUND

• Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.

  PMID: 32320003 BACKGROUND

• Moores LK, Tritschler T, Brosnahan S, Carrier M, Collen JF, Doerschug K, Holley AB, Jimenez D, Le Gal G, Rali P, Wells P. Prevention, Diagnosis, and Treatment of VTE in Patients With Coronavirus Disease 2019: CHEST Guideline and Expert Panel Report. Chest. 2020 Sep;158(3):1143-1163. doi: 10.1016/j.chest.2020.05.559. Epub 2020 Jun 2.

  PMID: 32502594 BACKGROUND

• Spyropoulos AC, Levy JH, Ageno W, Connors JM, Hunt BJ, Iba T, Levi M, Samama CM, Thachil J, Giannis D, Douketis JD; Subcommittee on Perioperative, Critical Care Thrombosis, Haemostasis of the Scientific, Standardization Committee of the International Society on Thrombosis and Haemostasis. Scientific and Standardization Committee communication: Clinical guidance on the diagnosis, prevention, and treatment of venous thromboembolism in hospitalized patients with COVID-19. J Thromb Haemost. 2020 Aug;18(8):1859-1865. doi: 10.1111/jth.14929. No abstract available.

  PMID: 32459046 BACKGROUND

• 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, Quere 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.

  PMID: 32311448 BACKGROUND

• Poterucha TJ, Libby P, Goldhaber SZ. More than an anticoagulant: Do heparins have direct anti-inflammatory effects? Thromb Haemost. 2017 Feb 28;117(3):437-444. doi: 10.1160/TH16-08-0620. Epub 2016 Dec 15.

  PMID: 27975101 BACKGROUND

• Thachil J. The versatile heparin in COVID-19. J Thromb Haemost. 2020 May;18(5):1020-1022. doi: 10.1111/jth.14821. Epub 2020 Apr 27. No abstract available.

  PMID: 32239799 BACKGROUND

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• Linhardt RJ, Gunay NS. Production and chemical processing of low molecular weight heparins. Semin Thromb Hemost. 1999;25 Suppl 3:5-16.

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• Matzsch T, Bergqvist D, Hedner U, Ostergaard P. Effects of an enzymatically depolymerized heparin as compared with conventional heparin in healthy volunteers. Thromb Haemost. 1987 Feb 3;57(1):97-101.

  PMID: 3590085 BACKGROUND

• Padilla A, Gray E, Pepper DS, Barrowcliffe TW. Inhibition of thrombin generation by heparin and low molecular weight (LMW) heparins in the absence and presence of platelet factor 4 (PF4). Br J Haematol. 1992 Oct;82(2):406-13. doi: 10.1111/j.1365-2141.1992.tb06437.x.

  PMID: 1329921 BACKGROUND

• McFadyen JD, Stevens H, Peter K. The Emerging Threat of (Micro)Thrombosis in COVID-19 and Its Therapeutic Implications. Circ Res. 2020 Jul 31;127(4):571-587. doi: 10.1161/CIRCRESAHA.120.317447. Epub 2020 Jun 26.

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  PMID: 11772296 BACKGROUND

• Bochenek J, Puskulluoglu M, Krzemieniecki K. The antineoplastic effect of low-molecular-weight heparins - a literature review. Contemp Oncol (Pozn). 2013;17(1):6-13. doi: 10.5114/wo.2013.33766. Epub 2013 Mar 15.

  PMID: 23788954 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Tinzaparin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Karolina Akinosoglou, MD,PhD

  University Hospital of Patras

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolina Akinosoglou, MD,PhD

CONTACT

+306977762897; akin@upatras.gr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: September 8, 2021
• Study Start: October 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: April 30, 2022
• Last Updated: September 8, 2021

Record last verified: 2021-09

Locations

GR (7)