FREEDOM COVID Anticoagulation Strategy Randomized Trial

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 3600

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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

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
e. history of intracranial bleeding
f. history of bleeding diatheses (e.g., hemophilia)
g. history of gastrointestinal bleeding within previous 3 months
4
h. thrombolysis within the previous 7 days
i. presence of an epidural or spinal catheter
j. recent major surgery <14 days
k. uncontrolled hypertension (sBP > 200 mmHg or dBP > 120 mmHg)
l. other physician-perceived contraindications to anticoagulation
m. Platelet count <50 x109/L, INR >2.0, or baseline aPTT
>50 seconds
n. Hemoglobin <80 g/L (to minimize the likelihood of requiring red blood cell transfusion if potential bleeding were to occur)
o. current treatment with antithrombotics or antiplatelet agents including but not limited to ticagrelor, prasugrel, and aspirin> 100mg, or non-steroidal anti-inflammatory drugs (e.g. ibuprofen, naproxyn, etc.) due to increased risk of bleeding, unless such agents can be permanently discontinued (aspirin <= 100mg and clopidogrel <=75mg is permitted)
7. Acute or subacute bacterial endocarditis
8. History of heparin induced thrombocytopenia (HIT) or other heparin allergy including hypersensitivity
9. Patients with non-COVID-19 related clinical condition for which life expectancy is <6 months
10. Pregnancy (women of childbearing potential are required to have a negative pregnancy test prior to enrollment)
11. Active enrollment in other trials related to anticoagulation
12. Patients has end stage kidney disease (ESKD) on chronic dialysis
13. Patient is a member of a vulnerable population: In the judgment of the investigator the patient is unable to give Informed Consent for reasons of severe chronic incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention. Note: Patients who are unable to give informed consent because of their acute illness may enter the trial if consent is provided by a legally authorized representative.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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