Hemostasis in COVID-19: an Adaptive Clinical Trial

  • STATUS
    Recruiting
  • participants needed
    310
  • sponsor
    University of Sao Paulo General Hospital
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Updated on 16 February 2024
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aspirin
respiratory distress
enoxaparin
covid-19
hemostasis
thrombophilia
hypercoagulability

Summary

Hypercoagulability has been demonstrated in COVID-19, leading to respiratory distress and increased mortality. This is adaptive clinical trial to compare effectiveness and safety of four therapeutic strategies in hospital mortality in patients with COVID-19: standard prophylaxis, therapeutic dose anticoagulation, inhaled UFH associated with standard prophylaxis and ASA associated with standard prophylaxis.

Details
Condition Covid 19
Age 18years - 100years
Treatment unfractionated Heparin, Enoxaparin, Unfractionated heparin nebulized, acetylsalicylic acid
Clinical Study IdentifierNCT04466670
SponsorUniversity of Sao Paulo General Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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

Exclusion Criteria

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
Known allergy to UFH or LMWH
History of heparin-induced thrombocytopenia (HIT) within the past 6 months
Bacterial endocarditis
Exclusion criteria at phase 1
Platelets < 25,000
\. Exclusion criteria at phase 2
Platelets < 50,000
History of surgery in the last 30 days
Intervention C: allergy to ASS and long-term use of antiplatelet drug
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