Status:
COMPLETED
Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis Admitted With COVID-19 Pneumonia (PROTHROMCOVID)
Lead Sponsor:
Hospital Universitario Infanta Leonor
Conditions:
Covid19
Thrombosis
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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)
- 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
- Age \> 18 years
- Weight 50-100 Kg
- 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
- Patients who need mechanical ventilation (invasive or non-invasive), high flow nasal cannula or admission to ICU at the moment of randomization.
- Current diagnosis of acute bronchial asthma attack.
- History or clinical suspicion of pulmonary fibrosis.
- Current diagnosis or suspicion of pulmonary thromboembolism or deep vein thrombosis.
- Patients who need anticoagulant treatment due to previous venous or arterial thrombotic disease, or due to atrial fibrillation.
- Patients with pneumonectomy or lobectomy.
- Renal failure with Glomerular filtration \<30 ml/min/1.73m2
- Patients with contraindication for anticoagulant treatment.
- Congenital bleeding disorders.
- Hypersensitivity to tinzaparin or UFH or some of its excipients.
- History of heparin-induced thrombocytopenia.
- Active bleeding or situation that predispose to bleeding.
- Moderate or severe anaemia (Hb\<10 g/dl)
- Low platelet count \< 80000/µl
- Patients with life expectancy less than 3 months due to primary disease evaluated by the physician.
- Patients currently intubated or intubated between the screening and the randomization.
- Pregnancy.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2021
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT04730856
Start Date
February 1 2021
End Date
December 20 2021
Last Update
September 15 2022
Active Locations (18)
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1
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
2
Hospital Universitario del Vinalopó
Alicante, Spain
3
Hospital Clínic Barcelona
Barcelona, Spain
4
Hospital Universitario Vall d'Hebron
Barcelona, Spain