NCT04466670
Unknown
Phase 2
Dynamics of Hemostatic Parameters in COVID-19 and Comparison of Intervention Strategies Through Adaptive Clinical Trial
ConditionsCOVID-19
Overview
- Phase
- Phase 2
- Intervention
- Unfractionated heparin nebulized
- Conditions
- COVID-19
- Sponsor
- University of Sao Paulo General Hospital
- Enrollment
- 379
- Locations
- 1
- Primary Endpoint
- Hospital discharge - alive / death
- Last Updated
- 4 years ago
Overview
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.
Investigators
Vanderson Geraldo Rocha
Full professor
University of Sao Paulo General Hospital
Eligibility Criteria
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
- •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
Arms & Interventions
phase 2B
inhaled unfractionated heparin
Intervention: Unfractionated heparin nebulized
phase 2A
Acetylsalicylic acid
Intervention: acetylsalicylic acid
Placebo
Placebo arm for Phase 2A
Intervention: acetylsalicylic acid
Outcomes
Primary Outcomes
Hospital discharge - alive / death
Time Frame: 30 days
Number of COVID-19 positive patients who are alive within 30 days of symptoms onset
Secondary Outcomes
- Length of renal replacement therapy free days(30 days)
- Length of mechanical ventilation free days(30 days)
- Number of documented venous thromboembolism or arterial thrombosis(3 months)
Study Sites (1)
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