Hemostasis in COVID-19: an Adaptive Clinical Trial

COVID-19 Clinical Trial

Official title:

Dynamics of Hemostatic Parameters in COVID-19 and Comparison of Intervention Strategies Through Adaptive Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04466670
• Other study ID #: 33788820.9.0000.0068
• Status: Recruiting
• Phase: Phase 2
• Start date: July 11, 2020
• Est. completion date: May 30, 2022

Study information

• Verified date: June 2021
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 379
• Est. completion date: May 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• acetylsalicylic acid
acetylsalicylic acid (ASA) 100 mg daily PO up to 14 days OR arterial oxygen saturation greater than or equal to 92% on room air OR PaO2 to FiO2 ratio greater than 200 for 2 consecutive days, whichever is first.
• Unfractionated heparin nebulized
unfractionated heparin - 25,000 U/ 5 ml nebulized inhalation every 6 hours up to 14 days OR arterial oxygen saturation greater than or equal to 92% on room air OR PaO2 to FiO2 ratio greater than 200 for 2 consecutive days, whichever is first.

Locations

Country	Name	City	State
Brazil	Vanderson Rocha	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital discharge - alive / death	Number of COVID-19 positive patients who are alive within 30 days of symptoms onset	30 days
Secondary	Length of mechanical ventilation free days	Comparison of length of mechanical ventilation free days between each treatment arm	30 days
Secondary	Length of renal replacement therapy free days	Comparison of length of renal replacement therapy free days between each treatment arm	30 days
Secondary	Number of documented venous thromboembolism or arterial thrombosis	Comparison of number of thrombosis events between each treatment arm.	3 months