To determine efficacy, safety and optimal dosing of anticoagulant strategies to prevent adverse outcomes in hospitalized COVID-19 patients.

Phase 4

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Registration Number: CTRI/2020/11/029345

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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 Î¼g /mL

ii. CRP >2 mg/L

iii. Ferritin >300 Î¼g /L

iv. Lymphopenia <1500 cells /m3

2. Patient or legal guardian provides written informed consent

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

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

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

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 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?? Effectiveness â?? The primary effectiveness outcome endpoint <br/ ><br>is the time to first event rate within 30 days of randomization of <br/ ><br>the composite of all-cause mortality, intubation requiring <br/ ><br>mechanical ventilation, systemic thromboembolism (including <br/ ><br>pulmonary emboli) confirmed by imaging or requiring surgical <br/ ><br>intervention OR ischemic stroke confirmed by imaging <br/ ><br>â?? Safety â?? The primary safety outcome endpoint is the in-hospital <br/ ><br>rate of BARC 3 or 5 bleeding (binary)Timepoint: within 30 days of randomization

Secondary Outcome Measures

Name	Time	Method
Myocardial infarction <br/ ><br>Deep vein thrombosis <br/ ><br>Intubation and mechanical ventilation <br/ ><br>All-cause death <br/ ><br>Cause specific death <br/ ><br>Stroke <br/ ><br>Pulmonary emboli <br/ ><br>Systemic thromboembolism <br/ ><br>surgical intervention <br/ ><br>Organ support-free days <br/ ><br>Total ICU days <br/ ><br>Need for non-invasive mechanical ventilation/high flow nasal <br/ ><br>cannula <br/ ><br>Ventilator-free days <br/ ><br>Total hospital days <br/ ><br>Hospital-free days <br/ ><br>BARC 2, 3 or 5 bleeding <br/ ><br>Laboratory confirmed Heparin induced thrombocytopenia (HIT)Timepoint: each <br/ ><br>assessed at 30 days <br/ ><br>and 90 days after <br/ ><br>randomization