Hypercoagulability has been demonstrated in COVID-19, leading to respiratory distress and increased mortality. This is an adaptive clinical trial to compare the efficacy and safety of two experimental strategies in patients with COVID-19: ASA or inhaled UFH associated with standard VTE prophylaxis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
379
acetylsalicylic acid (ASA) 100 mg daily PO up to 14 days OR arterial oxygen saturation greater than or equal to 92% on room air OR PaO2 to FiO2 ratio greater than 200 for 2 consecutive days, whichever is first.
unfractionated heparin - 25,000 U/ 5 ml nebulized inhalation every 6 hours up to 14 days OR arterial oxygen saturation greater than or equal to 92% on room air OR PaO2 to FiO2 ratio greater than 200 for 2 consecutive days, whichever is first.
Vanderson Rocha
São Paulo, Brazil
RECRUITINGHospital discharge - alive / death
Number of COVID-19 positive patients who are alive within 30 days of symptoms onset
Time frame: 30 days
Length of mechanical ventilation free days
Comparison of length of mechanical ventilation free days between each treatment arm
Time frame: 30 days
Length of renal replacement therapy free days
Comparison of length of renal replacement therapy free days between each treatment arm
Time frame: 30 days
Number of documented venous thromboembolism or arterial thrombosis
Comparison of number of thrombosis events between each treatment arm.
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.