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

September 13, 2022 updated by: Hospital Universitario Infanta Leonor
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

311

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Spain
      • A Coruña, Spain
        • Complejo Hospitalario Universitario A Coruña
      • Alicante, Spain
        • Hospital Universitario del Vinalopó
      • Barcelona, Spain
        • Hospital Universitario Vall d'Hebrón
      • Barcelona, Spain
        • Hospital Clinic Barcelona
      • Burgos, Spain
        • Hospital Universitario De Burgos
      • Cuenca, Spain
        • Hospital Virgen De La Luz
      • Girona, Spain
        • Hospital Universitari de Girona Doctor Josep Trueta
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain
        • Hospital Universitario Infanta Leonor
      • Madrid, Spain
        • Hospital Universitario Infanta Sofía
      • Madrid, Spain
        • Hospital Universitario 12 Octubre
      • Madrid, Spain
        • Hospital de Emergencias Enfermera Isabel Zendal
      • Pontevedra, Spain
        • Complexo Hospitalario Universitario de Pontevedra
      • Valencia, Spain
        • Hospital Clinico Universitario de Valencia
      • Valladolid, Spain
        • Hospital Clínico Universitario de Valladolid
      • Vigo, Spain
        • Hospital Álvaro Cunqueiro

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

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined variable that includes outcomes 2, 3 and 4 detailed below
Time Frame: 30 days
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
Time Frame: 30 days
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
Time Frame: 30 days
Mechanical ventilation (invasive or non-invasive) free survival.
30 days
Overall survival at 30 days.
Time Frame: 30 days
Overall survival at 30 days: number of deaths.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Collaborators and Investigators

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

Sponsor

Hospital Universitario Infanta Leonor

Investigators

  • Study Chair: Nuria Muñoz Rivas, Hospital Universitario Infanta Leonor

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 (Actual)

February 1, 2021

Primary Completion (Actual)

October 20, 2021

Study Completion (Actual)

December 20, 2021

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 28, 2021

First Posted (Actual)

January 29, 2021

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROTHROMCOVID

Drug and device information, study documents

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

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.

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