Status:
UNKNOWN
Hemostasis in COVID-19: an Adaptive Clinical Trial
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
- Exclusion criteria at phase 1
- Platelet count \< 25,000/mm3
- Bacterial endocarditis
- Exclusion criteria at phase 2
- Platelet count \< 50,000/mm3
- History of surgery in the last 30 days
- Intervention A: allergy to ASA and long-term use of antiplatelet drug
- Intervention B: inhaled nitric oxide use
Key Trial Info
Start Date :
July 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2022
Estimated Enrollment :
379 Patients enrolled
Trial Details
Trial ID
NCT04466670
Start Date
July 11 2020
End Date
May 30 2022
Last Update
June 9 2021
Active Locations (1)
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1
Vanderson Rocha
São Paulo, Brazil, 05403-000