NCT04730856

Brief Summary

The main objective is to evaluate the efficacy and safety of three doses of tinzaparin (prophylactic, intermediate and therapeutic) in hospitalized patients with COVID-19 pneumonia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
311

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

January 14, 2021

Last Update Submit

September 13, 2022

Conditions

Covid19Thrombosis

Outcome Measures

Primary Outcomes (4)

  • Combined variable that includes outcomes 2, 3 and 4 detailed below

    Combined variable that includes outcomes 2, 3 and 4 detailed below (reduction of suspicion of systemic thrombotic symptomatic events and/or need for mechanical ventilation and/or death at day 30 after randomization).

    30 days

  • Reduction of suspicion of systemic thrombotic symptomatic events

    Reduction of symptomatic thrombotic events: rate of venous thromboembolism confirmed by objective test.

    30 days

  • Use of Mechanical ventilation invasive or non invasive including high flow nasal cannula oxigen

    Mechanical ventilation (invasive or non-invasive) free survival.

    30 days

  • Overall survival at 30 days.

    Overall survival at 30 days: number of deaths.

    30 days

Secondary Outcomes (1)

  • Number of bleedings and adverse reactions

    90 days

Study Arms (3)

Tinzaparin 4500 UI/day

ACTIVE COMPARATOR

Procedure: Tinzaparin 4500 UI/day SC until hospital discharge.

Drug: Tinzaparin

Tinzaparin 100 UI/Kg/day

ACTIVE COMPARATOR

Procedure: Tinzaparin 100 UI/Kg/day SC until hospital discharge.

Drug: Tinzaparin

Tinzaparin 175 UI/Kg/day

ACTIVE COMPARATOR

Procedure: Tinzaparin 175 UI/Kg/day SC until hospital discharge.

Drug: Tinzaparin

Interventions

TinzaparinDRUG

day subcutaneously • Follow-up phase 1 (Day 15 to day 30): The information is obtained at discharge and on day +14, + 28 on 30 days. The latter information is obtained from patients, from medical records or by telephone contact at the patient's home. • Follow-up phase 2 (At 3 months: Information is obtained from patients, medical records, or by telephone contact at the patient's home.

Tinzaparin 100 UI/Kg/dayTinzaparin 175 UI/Kg/dayTinzaparin 4500 UI/day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to hospital with COVID-19, PCR and/or Antigens Test + SARS-CoV-2 infection or (presence of infiltrate compatible with Chest X-ray or TC)
  • Patients with, at least, one of the following evolution disease risk criteria:
  • Sat 02\<94%
  • Need for oxygen therapy or pAO2/FiO2\<300mmHg or estimated PaO2/FiO2 based on SpO2/FiO2\<300 mmHg.
  • DD\>1000µg/L
  • PCR \>150mg/L
  • IL6 \>40pg/ml
  • Age \> 18 years
  • Weight 50-100 Kg
  • After receiving oral and written information about the study, patient must give Informed Consent duly signed and dated before performing any activity related to the study.

You may not qualify if:

  • Patients who need mechanical ventilation (invasive or non-invasive), high flow nasal cannula or admission to ICU at the moment of randomization.
  • Current diagnosis of acute bronchial asthma attack.
  • History or clinical suspicion of pulmonary fibrosis.
  • Current diagnosis or suspicion of pulmonary thromboembolism or deep vein thrombosis.
  • Patients who need anticoagulant treatment due to previous venous or arterial thrombotic disease, or due to atrial fibrillation.
  • Patients with pneumonectomy or lobectomy.
  • Renal failure with Glomerular filtration \<30 ml/min/1.73m2
  • Patients with contraindication for anticoagulant treatment.
  • Congenital bleeding disorders.
  • Hypersensitivity to tinzaparin or UFH or some of its excipients.
  • History of heparin-induced thrombocytopenia.
  • Active bleeding or situation that predispose to bleeding.
  • Moderate or severe anaemia (Hb\<10 g/dl)
  • Low platelet count \< 80000/µl
  • Patients with life expectancy less than 3 months due to primary disease evaluated by the physician.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Location

Hospital Universitario del Vinalopó

Alicante, Spain

Location

Hospital Clínic Barcelona

Barcelona, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario de Burgos

Burgos, Spain

Location

Hospital Virgen de la Luz

Cuenca, Spain

Location

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital de Emergencias Enfermera Isabel Zendal

Madrid, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario 12 Octubre

Madrid, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, Spain

Location

Hospital Universitario Infanta Sofía

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Complexo Hospitalario Universitario de Pontevedra

Pontevedra, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Spain

Location

Related Publications (5)

  • Lew TW, Kwek TK, Tai D, Earnest A, Loo S, Singh K, Kwan KM, Chan Y, Yim CF, Bek SL, Kor AC, Yap WS, Chelliah YR, Lai YC, Goh SK. Acute respiratory distress syndrome in critically ill patients with severe acute respiratory syndrome. JAMA. 2003 Jul 16;290(3):374-80. doi: 10.1001/jama.290.3.374.

    PMID: 12865379BACKGROUND

  • 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: 32311448BACKGROUND

  • Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

    PMID: 32171076BACKGROUND

  • Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

    PMID: 31986264RESULT

  • Munoz-Rivas N, Aibar J, Gabara-Xanco C, Trueba-Vicente A, Urbelz-Perez A, Gomez-Del Olmo V, Demelo-Rodriguez P, Rivera-Gallego A, Bosch-Nicolau P, Perez-Pinar M, Rios-Prego M, Madridano-Cobo O, Ramos-Alonso L, Alonso-Carrillo J, Francisco-Albelsa I, Marti-Saez E, Maestre-Peiro A, Mendez-Bailon M, Hernandez-Rivas JA, Torres-Macho J; PROTHROMCOVID Trial Investigators. Efficacy and Safety of Tinzaparin in Prophylactic, Intermediate and Therapeutic Doses in Non-Critically Ill Patients Hospitalized with COVID-19: The PROTHROMCOVID Randomized Controlled Trial. J Clin Med. 2022 Sep 24;11(19):5632. doi: 10.3390/jcm11195632.

    PMID: 36233500DERIVED

MeSH Terms

Conditions

COVID-19Thrombosis

Interventions

Tinzaparin

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Nuria Muñoz Rivas

    Hospital Universitario Infanta Leonor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 29, 2021

Study Start

February 1, 2021

Primary Completion

October 20, 2021

Study Completion

December 20, 2021

Last Updated

September 15, 2022

Record last verified: 2022-09

Locations

ES(18)