COVID-19 MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ENOXAPARIN SODIUM
CAS Number: 9041-08-1
Concentration unit: mg/l milligram(s)/litre
Concentration type: range
Concentration number: 20-1
Sponsors
Icahn School of Medicine at Mount Sinai
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 125
Exclusion criteria
Exclusion criteria: 1. Age 200 mmHg or dBP > 120 mmHg) l. other physician-perceived contraindications to anticoagulation m. Platelet count 2.0, or baseline aPTT >50 seconds n. Hemoglobin 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effectiveness of enoxaparin and apixaban in patients hospitalized (but not yet intubated) with confirmed COVID-19;Secondary Objective: To determine the safety of enoxaparin and apixaban in patients hospitalized (but not yet intubated) with confirmed COVID-19;Primary end point(s): Effectiveness – The primary effectiveness outcome endpoint is the time to first event rate within 30 days of randomization of the composite of all-cause mortality, intubation requiring mechanical ventilation, systemic thromboembolism (including pulmonary emboli) confirmed by imaging or requiring surgical intervention OR ischemic stroke confirmed by imaging ? Safety – The primary safety outcome endpoint is the in-hospital rate of BARC 3 or 5 bleeding (binary);Timepoint(s) of evaluation of this end point: 30 days after the randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Myocardial infarction (according to the 4th universal definition, types 1,2, and 3) 2. Deep vein thrombosis with confirmation on imaging 3. Intubation and mechanical ventilation 4. All-cause death 5. Cause specific death 6. Stroke confirmed by imaging or autopsy (all, ischemic and hemorrhagic) 7. Pulmonary emboli confirmed by imaging or autopsy 8. Systemic thromboembolism confirmed by imaging or requiring surgical intervention 9. Organ support-free days 10. Total ICU days 11. ICU-free days 12. Need for non-invasive mechanical ventilation or high flow nasal cannula 13. Ventilator-free days (days alive free of mechanical ventilator support) 14. Total hospital days 15. Hospital-free days (days alive out of hospital assessed through 90 days post randomization) 16. BARC 2, 3 or 5 bleeding 17. Laboratory confirmed Heparin induced thrombocytopenia (HIT);Timepoint(s) of evaluation of this end point: 30 days and 90 days after randomization) | — |
Countries
Italy, Poland, Portugal, Spain, United States
Contacts
Public ContactClinical Trials Information
Valentin Fuster,MD.PhD
Outcome results
None listed