Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 14, 2021
First Posted Date  ICMJE January 29, 2021
Last Update Posted Date June 4, 2021
Actual Study Start Date  ICMJE February 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2021)
  • 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.
  • Use of Mechanical ventilation [ Time Frame: 30 days ]
    Mechanical ventilation (invasive or non-invasive) free survival.
  • 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.
  • Overall survival at 30 days. [ Time Frame: 30 days ]
    Overall survival at 30 days: number of deaths.
  • Length of hospital stay (days) [ Time Frame: 30 days ]
    Length of hospital stay (days): number of days from hospital admission to hospital discharge
  • Length of ICU stay (days) [ Time Frame: 30 days ]
    Length of ICU stay (days): number of days from admission to ICU to discharge ICU
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2021)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2021)
Number of bleedings and adverse reactions [ Time Frame: 30 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis Admitted With COVID-19 Pneumonia (PROTHROMCOVID)
Official Title  ICMJE Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis Admitted With COVID-19 Pneumonia (PROTHROMCOVID)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • Thrombosis
Intervention  ICMJE 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.

Study Arms  ICMJE
  • Active Comparator: Tinzaparin 4500 UI/day
    Procedure: Tinzaparin 4500 UI/day SC until hospital discharge.
    Intervention: Drug: Tinzaparin
  • Active Comparator: Tinzaparin 100 UI/Kg/day
    Procedure: Tinzaparin 100 UI/Kg/day SC until hospital discharge.
    Intervention: Drug: Tinzaparin
  • Active Comparator: Tinzaparin 175 UI/Kg/day
    Procedure: Tinzaparin 175 UI/Kg/day SC until hospital discharge.
    Intervention: Drug: Tinzaparin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2021)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ANGEL PUEYO +34 618 448 807 angel.pueyo@salud.madrid.org
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04730856
Other Study ID Numbers  ICMJE PROTHROMCOVID
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital Universitario Infanta Leonor
Study Sponsor  ICMJE Hospital Universitario Infanta Leonor
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Nuria Muñoz Rivas Hospital Universitario Infanta Leonor
PRS Account Hospital Universitario Infanta Leonor
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP