Pragmatic randomized clinical trial of patients admitted to the hospital with confirmed COVID-19 infection and elevated D-Dimer. Randomization 1:1 - Group 1 will undergo a routine full anticoagulation (oral or parenteral when needed) strategy; and group 2 will receive usual standard of care with prophylactic anticoagulation
Patients admitted to hospital with confirmed COVID-19, and who meet the eligibility criteria will be invited to participate in the proposed study. Following the application of the informed consent form, they will collect the D-dimer (if they have not yet collected it routinely from the hospital) and confirm the value over the normal limit in patients with confirmed COVID-19, will be randomized to 2 groups in the 1:1 ratio. Group 1 will follow the strategy of routine use of full anticoagulation therapy (oral or parenteral when indicated); and group 2 will follow the usual standard care with in-hospital prophylactic anticoagulation (without routine full anticoagulation).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
615
Routine full anticoagulation strategy
Usual standard of care and currently have no indication of full anticoagulation.
Hierarchical composite endpoint composed of mortality, number of days alive, number of days in the hospital and number of days with oxygen therapy at the end of 30 days.
The primary objective will be analyzed using the win ratio approach comparing every participant of treatment group to every participant of control group to determine a winner.
Time frame: In 30 days
Incidence of Venous thromboembolism
Time frame: In 30 days
Incidence of acute myocardial infarction
Time frame: In 30 days
Incidence of stroke
Time frame: In 30 days
Number of days using oxygen therapy
Time frame: In 30 days
Peak of troponin
Time frame: In 30 days
Peak of D-dimer
Time frame: In 30 days
Incidence of Major bleeding and clinically relevant non-major bleeding by the ISTH criteria
It will be considered the main safety endpoint
Time frame: In 30 days
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