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Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis Admitted With COVID-19 Pneumonia (PROTHROMCOVID)

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ClinicalTrials.gov Identifier: NCT04730856
Recruitment Status : Recruiting
First Posted : January 29, 2021
Last Update Posted : June 4, 2021
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario Infanta Leonor

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.

Condition or disease Intervention/treatment Phase
Covid19 Thrombosis Drug: Tinzaparin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis Admitted With COVID-19 Pneumonia (PROTHROMCOVID)
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tinzaparin 4500 UI/day
Procedure: Tinzaparin 4500 UI/day SC until hospital discharge.
Drug: Tinzaparin

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.


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

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.


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

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.





Primary Outcome Measures :
  1. Reduction of suspicion of systemic thrombotic symptomatic events [ Time Frame: 30 days ]
    Reduction of symptomatic thrombotic events: rate of venous thromboembolism confirmed by objective test.

  2. Use of Mechanical ventilation [ Time Frame: 30 days ]
    Mechanical ventilation (invasive or non-invasive) free survival.

  3. Progression on the WHO Progression Scale during follow-up. [ Time Frame: 30 days ]
    Progression on the WHO (World Health Organization) Progression Scale during follow-up. Score: 0 to 8 points. Worst situation corresponds to 8 points.

  4. Overall survival at 30 days. [ Time Frame: 30 days ]
    Overall survival at 30 days: number of deaths.

  5. Length of hospital stay (days) [ Time Frame: 30 days ]
    Length of hospital stay (days): number of days from hospital admission to hospital discharge

  6. Length of ICU stay (days) [ Time Frame: 30 days ]
    Length of ICU stay (days): number of days from admission to ICU to discharge ICU


Secondary Outcome Measures :
  1. Number of bleedings and adverse reactions [ Time Frame: 90 days ]

    Safety of the different strategies of prophylaxis and anticoagulation: number of bleedings and adverse reactions in each group:

    Evaluation of the following variables:

    Incidence of major bleeding, defined as meeting any of these criteria:

    a) fatal bleeding or bleeding that occurs in a critical area or organ (for example, intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome), b ) causes a drop in hemoglobin level of 20 g/L or more, or c) requires the transfusion of 2 or more units of whole blood or packed red blood cells.

    Incidence of clinically relevant non-major bleeding: manifest, spontaneous or post-traumatic bleeding, which does not meet the criteria for major bleeding but which in the judgment of the investigator is relevant.

    Incidence of clinically relevant bleeding: all major and non-major hemorrhages clinically relevant.

    Incidence of adverse reactions.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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)
  2. 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
  3. Age > 18 years
  4. Weight 50-100 Kg
  5. 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.

Exclusion Criteria:

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

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): NCT04730856


Contacts
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Contact: ANGEL PUEYO +34 618 448 807 angel.pueyo@salud.madrid.org

Locations
Show Show 18 study locations
Sponsors and Collaborators
Hospital Universitario Infanta Leonor
Investigators
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Study Chair: Nuria Muñoz Rivas Hospital Universitario Infanta Leonor
Publications of Results:
Other 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: Hospital Universitario Infanta Leonor
ClinicalTrials.gov Identifier: NCT04730856    
Other Study ID Numbers: PROTHROMCOVID
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pneumonia
Thrombosis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Tinzaparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action