Official Title
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.

Completed
COVID19
Thrombosis

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.

Eligibility 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Spain
Locations

Complejo Hospitalario Universitario A Coruña
A Coruña, Spain

Hospital Universitario del Vinalopó
Alicante, Spain

Hospital Clínic Barcelona
Barcelona, Spain

Hospital Universitario Vall d'Hebron
Barcelona, Spain

Hospital Universitario de Burgos
Burgos, Spain

Hospital Virgen de la Luz
Cuenca, Spain

Hospital Universitari de Girona Doctor Josep Trueta
Girona, Spain

Hospital Clínico San Carlos
Madrid, Spain

Hospital de Emergencias Enfermera Isabel Zendal
Madrid, Spain

Hospital General Universitario Gregorio Marañón
Madrid, Spain

Hospital Universitario 12 Octubre
Madrid, Spain

Hospital Universitario Infanta Leonor
Madrid, Spain

Hospital Universitario Infanta Sofía
Madrid, Spain

Hospital Universitario Ramón y Cajal
Madrid, Spain

Complexo Hospitalario Universitario de Pontevedra
Pontevedra, Spain

Hospital Clínico Universitario de Valencia
Valencia, Spain

Hospital Clínico Universitario de Valladolid
Valladolid, Spain

Hospital Álvaro Cunqueiro
Vigo, Spain

Nuria Muñoz Rivas, Study Chair
Hospital Universitario Infanta Leonor

Hospital Universitario Infanta Leonor
NCT Number
MeSH Terms
COVID-19
Pneumonia
Thrombosis
Tinzaparin
Heparin, Low-Molecular-Weight
Dalteparin