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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
311
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.
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital Universitario del Vinalopó
Alicante, Spain
Combined variable that includes outcomes 2, 3 and 4 detailed below
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).
Time frame: 30 days
Reduction of suspicion of systemic thrombotic symptomatic events
Reduction of symptomatic thrombotic events: rate of venous thromboembolism confirmed by objective test.
Time frame: 30 days
Use of Mechanical ventilation invasive or non invasive including high flow nasal cannula oxigen
Mechanical ventilation (invasive or non-invasive) free survival.
Time frame: 30 days
Overall survival at 30 days.
Overall survival at 30 days: number of deaths.
Time frame: 30 days
Number of bleedings and adverse reactions
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.
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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
...and 8 more locations
Time frame: 90 days