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 19 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	18-100 years
Treatment	unfractionated Heparin, Enoxaparin, Unfractionated heparin nebulized, acetylsalicylic acid
Clinical Study Identifier	NCT04466670
Sponsor	University of Sao Paulo General Hospital
Last Modified on	19 February 2024

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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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Hemostasis in COVID-19: an Adaptive Clinical Trial