COVID-19
Conditions
Keywords
SARS-CoV-2, Thrombosis, Coagulopathy, Anticoagulation, Respiratory failure
Brief summary
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.
Interventions
DRUGacetylsalicylic 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.
DRUGUnfractionated heparin nebulized
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.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult ≥18 years of age at time of enrollment * Subjects with a positive COVID-19 diagnosis by RT-PCR or serologic testing * Subject (or legally authorized representative) must be willing, understanding and able to provide written informed consent. * Only at phase 2: * onset of symptoms must not exceed 4 weeks * ICU patients * PaO2 to FiO2 ratio \< 200
Exclusion criteria
1. General * Indications for therapeutic anticoagulation * History of chronic lung disease oxygen dependent * Pregnancy * Death considered imminent and inevitable within 24 hours * Patients under exclusive palliative care * Participation in another trial of investigational drug * Body weight \< 40 Kg * Total bilirubin \> 20 mg/dL * Severe active bleeding * Persistent GI bleeding * Known allergy to UFH or LMWH * History of heparin-induced thrombocytopenia (HIT) within the past 6 months 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital discharge - alive / death | 30 days | Number of COVID-19 positive patients who are alive within 30 days of symptoms onset |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of mechanical ventilation free days | 30 days | Comparison of length of mechanical ventilation free days between each treatment arm |
| Length of renal replacement therapy free days | 30 days | Comparison of length of renal replacement therapy free days between each treatment arm |
| Number of documented venous thromboembolism or arterial thrombosis | 3 months | Comparison of number of thrombosis events between each treatment arm. |
Countries
Brazil
Outcome results
None listed