EUCTR2020-005763-31-PL
Active, not recruiting
Phase 1
FREEDOM COVID Anticoagulation Strategy Randomized Trial - FREEDOM COVID-19
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 3600
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Hospitalization within the prior 24 hours for either confirmed (based on PCR or antigen positive test for SARS\-CoV\-2\) or suspected COVID\-19 based on 3 criteria (all 3 must be present for suspected cases):
- •a. Fever \>38 degrees Celsius
- •b. O2 saturation \=94
- •c. Abnormal laboratory marker (at least 1\)
- •i. d\-dimer \=1\.0 µg /mL
- •ii. CRP \>2 mg/L
- •iii. Ferritin \>300 µg /L
- •iv. Lymphopenia \<1500 cells /m3
- •2\. Patient or legal guardian provides written informed consent
- •Are the trial subjects under 18? no
Exclusion Criteria
- •1\. Age \<18 years
- •2\. Mechanical ventilation on admission or high likelihood for the need for invasive mechanical ventilation within 24 hours of admission
- •3\. Anticipated duration of hospital stay \<72 hours
- •4\. Treatment with therapeutic dose UFH or LMWH, vitamin K antagonists, or NOACs within seven days
- •5\. Active bleeding
- •6\. Risk factors for bleeding, including:
- •a. intracranial surgery or stroke within 3 months
- •b. history of intracerebral arteriovenous malformation
- •c. cerebral aneurysm or mass lesions of the central nervous system
- •d. intracranial malignancy
Outcomes
Primary Outcomes
Not specified
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