A Phase 2 interventional study of acetylsalicylic acid and Unfractionated heparin nebulized in COVID-19, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-09.
Sponsored by University of Sao Paulo General Hospital · Phase 2, Interventional, and Treatment
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.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's planned enrollment of 379 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Sao Paulo General Hospital is the lead sponsor of 608 studies on the registry; 97 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Only at phase 2:
Exclusion Criteria:
General
Exclusion criteria at phase 1
Exclusion criteria at phase 2
Observational arm
Acetylsalicylic acid
Drug: acetylsalicylic acid
inhaled unfractionated heparin
Drug: Unfractionated heparin nebulized
Placebo arm for Phase 2A
Drug: acetylsalicylic acid
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.
Also known as: aspirin
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.
Hospital 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 study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aspirin
University of Sao Paulo General Hospital →