Hemostasis in COVID-19: an Adaptive Clinical Trial

• Status: Recruiting
• Trial end date: 2022-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Treatments: Aspirin; Calcium heparin; Enoxaparin; Heparin

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:

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. Exclusion criteria at phase 1

• Platelet count < 25,000/mm3

• Bacterial endocarditis

3. 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