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

Not Applicable

Completed

• Conditions: Covid19; Thrombosis
• Interventions: Drug: Tinzaparin

• Registration Number: NCT04730856
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-01-29
• Study Start: 2021-02-01
• Primary Completion: 2021-10-20
• Study Completion: 2021-12-20
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 311

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tinzaparin 4500 UI/day	Tinzaparin	Procedure: Tinzaparin 4500 UI/day SC until hospital discharge.
Tinzaparin 100 UI/Kg/day	Tinzaparin	Procedure: Tinzaparin 100 UI/Kg/day SC until hospital discharge.
Tinzaparin 175 UI/Kg/day	Tinzaparin	Procedure: Tinzaparin 175 UI/Kg/day SC until hospital discharge.

Primary Outcome Measures

Name	Time	Method
Reduction of suspicion of systemic thrombotic symptomatic events	30 days	Reduction of symptomatic thrombotic events: rate of venous thromboembolism confirmed by objective test.
Combined variable that includes outcomes 2, 3 and 4 detailed below	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).
Use of Mechanical ventilation invasive or non invasive including high flow nasal cannula oxigen	30 days	Mechanical ventilation (invasive or non-invasive) free survival.
Overall survival at 30 days.	30 days	Overall survival at 30 days: number of deaths.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (18)

Complejo Hospitalario Universitario A Coruña; 🇪🇸 A Coruña, Spain

Hospital Virgen de la Luz; 🇪🇸 Cuenca, Spain

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario del Vinalopó; 🇪🇸 Alicante, Spain

Hospital Clínic Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario de Burgos; 🇪🇸 Burgos, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital de Emergencias Enfermera Isabel Zendal; 🇪🇸 Madrid, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Universitari de Girona Doctor Josep Trueta; 🇪🇸 Girona, Spain

Hospital Universitario 12 Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain

Hospital Universitario Infanta Sofía; 🇪🇸 Madrid, Spain

Complexo Hospitalario Universitario de Pontevedra; 🇪🇸 Pontevedra, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Spain