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

Sponsor
Hospital Universitario Infanta Leonor (Other)
Overall Status
Recruiting
CT.gov ID
NCT04730856
Collaborator
(none)
600
Enrollment
18
Locations
3
Arms
5.9
Anticipated Duration (Months)
33.3
Patients Per Site
5.6
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jul 31, 2021

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Reduction of suspicion of systemic thrombotic symptomatic events [30 days]

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

  2. Use of Mechanical ventilation [30 days]

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

  3. Progression on the WHO Progression Scale during follow-up. [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. [30 days]

    Overall survival at 30 days: number of deaths.

  5. Length of hospital stay (days) [30 days]

    Length of hospital stay (days): number of days from hospital admission to hospital discharge

  6. Length of ICU stay (days) [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. Age > 18 years

  2. Weight 50-100 Kg

  3. 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Complejo Hospitalario Universitario A CoruñaA CoruñaSpain
2Hospital Universitario del VinalopóAlicanteSpain
3Hospital Clínic BarcelonaBarcelonaSpain
4Hospital Universitario Vall d'HebronBarcelonaSpain
5Hospital Universitario de BurgosBurgosSpain
6Hospital Virgen de la LuzCuencaSpain
7Hospital Universitari de Girona Doctor Josep TruetaGironaSpain
8Hospital Clínico San CarlosMadridSpain
9Hospital de Emergencias Enfermera Isabel ZendalMadridSpain
10Hospital General Universitario Gregorio MarañónMadridSpain
11Hospital Universitario 12 OctubreMadridSpain
12Hospital Universitario Infanta LeonorMadridSpain
13Hospital Universitario Infanta SofíaMadridSpain
14Hospital Universitario Ramón y CajalMadridSpain
15Complexo Hospitalario Universitario de PontevedraPontevedraSpain
16Hospital Clínico Universitario de ValenciaValenciaSpain
17Hospital Clínico Universitario de ValladolidValladolidSpain
18Hospital Álvaro CunqueiroVigoSpain

Sponsors and Collaborators

  • Hospital Universitario Infanta Leonor

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hospital Universitario Infanta Leonor
ClinicalTrials.gov Identifier:
NCT04730856
Other Study ID Numbers:
  • PROTHROMCOVID
First Posted:
Jan 29, 2021
Last Update Posted:
Jun 4, 2021
Last Verified:
Apr 1, 2021
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:

Study Results

No Results Posted as of Jun 4, 2021