Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04401293|
Recruitment Status : Completed
First Posted : May 26, 2020
Results First Posted : November 22, 2021
Last Update Posted : November 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Sars-CoV2 COVID||Drug: Enoxaparin Drug: Prophylactic/Intermediate Dose Enoxaparin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||257 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Due to the pragmatic nature of this study "open-label multi-center randomized active control trial" with pseudo-blinding mechanisms at the time of randomization the study subject and corresponding Site PIs will be blinded (unaware of specific treatment arm the patient is assigned to i.e. Arm 0 or Arm 1). The study pharmacists as well as data extractors and designated randomization personnel (i.e. research coordinators and/or research nurses performing the randomization process) will be un-blinded (aware of specific treatment arm the patient is assigned to i.e. Arm 0 or Arm 1). At the time of subject randomization study subjects will be stratified to either ICU level of care vs. Non-ICU level of care.|
|Official Title:||Systemic Anticoagulation With Full Dose Low Molecular Weight Heparin (LMWH) Vs. Prophylactic or Intermediate Dose LMWH in High Risk COVID-19 Patients (HEP-COVID Trial)|
|Actual Study Start Date :||April 26, 2020|
|Actual Primary Completion Date :||May 14, 2021|
|Actual Study Completion Date :||May 14, 2021|
Experimental: Full Dose LMWH anticoagulation therapy
Subjects in this study arm will be treated with therapeutic doses of subcutaneous low-molecular-weight heparin (enoxaparin). Enoxaparin 1mg/kg SQ BID for CrCl ≥ 30ml/min (or Enoxaparin 0.5mg/kg SQ BID for CrCl ≥ 15ml/min and < 30ml/min) during the course of their hospitalization.
Full Dose LMWH anticoagulation therapy
Active Comparator: Prophylactic/Intermediate Dose LMWH or UFH therapy
Subjects in this study arm will be treated with Local institutional standard-of-care for prophylactic-dose or intermediate-dose UFH or LMWH. Regimens allowed are UFH up to 22,500 IU daily in BID or TID doses (i.e. UFH 5000 IU SQ BID/TID or 7500 IU BID/TID), enoxaparin 30mg and 40mg SQ QD or BID (the use of weight-based enoxaparin i.e. 0.5mg/kg SQ BID for this arm is acceptable but strongly discouraged), dalteparin 2500IU or 5000IU QD.
Drug: Prophylactic/Intermediate Dose Enoxaparin
Prophylactic/Intermediate Dose LMWH or UFH therapy
- Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Day 30 ± 2 Days. [ Time Frame: Day 30 ± 2 days ]Risk of arterial thromboembolic events (including myocardial infarction, stroke, systemic embolism), venous thromboembolism (including symptomatic deep vein thrombosis (DVT) of the upper or lower extremity, asymptomatic proximal DVT of the lower extremity, non-fatal pulmonary embolism (PE)), and all-cause mortality at Day 30 ± 2 days.
- Major Bleeding [ Time Frame: Day 30 ± 2 days ]Risk of major bleeding defined using the International Society of Thrombosis and Haemostasis (ISTH) criteria
- Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Hospital Day 10 + 4 [ Time Frame: Day 10 + 4 ]The composite of arterial thromboembolic events (including myocardial infarction, stroke, systemic embolism), venous thromboembolism (including symptomatic deep vein thrombosis (DVT) of the upper or lower extremity, asymptomatic proximal DVT of the lower extremity, non-fatal pulmonary embolism (PE)), and all-cause mortality at Hospital Day 10 + 4
- Sepsis-induced Coagulopathy (SIC) Score [ Time Frame: Day 30 ± 2 days. ]
Sepsis-induced coagulopathy (SIC) score predicts likelihood of sepsis-induced coagulopathy based on ISTH guidelines.
The score uses the following domains:
- Platelets, K/uL (thousands per microliter)
- INR (International Normalized Ratio)
- D-Dimer Level
Platelet count > 100 cells x 10^9/L is 0 points, platelet count 50 to 100 cells x 10^9/L is 1 point and Platelet count < 50 cells x 10^9/L is 2 points. INR < 1.3 is 0 points, INR 1.3 to 1.7 is 1 point and INR > 1.7 is 2 points. D-Dimer level < 400 ng/mL is 0 points, D-Dimer level 400-4000 ng/mL is 2 points and D-Dimer level > 4000 ng/mL is 3 points. Fibrinogen level > 100 mg/dL is 0 points and fibrinogen level < 100 mg/dL is 1 point.
Calculated (SIC) scores yields a possible 0 to 6 points, where ≥4 predicts higher mortality rates within 30 days and greater risk of pulmonary embolism.
- Progression to Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: Day 30 ± 2 days. ]Progression to Acute Respiratory Distress Syndrome (ARDS) based on monitoring of patient conditions.
- Need for Intubation [ Time Frame: Day 30 ± 2 days. ]Need for Intubation will be based on monitoring of patient conditions.
- Re-hospitalization [ Time Frame: Day 30 ± 2 days. ]Need for Re-hospitalization will be based on monitoring of patient conditions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401293
|United States, New Jersey|
|Beth Israel Newark|
|Newark, New Jersey, United States, 07112|
|United States, New York|
|Bay Shore, New York, United States, 11706|
|Huntington, New York, United States, 11743|
|Lenox Hill Hospital|
|New York, New York, United States, 10075|
|Long Island Jewish Medical Center|
|Queens, New York, United States, 11040|
|Staten Island University Hospital|
|Staten Island, New York, United States, 10309|
|Principal Investigator:||Alex C Spyropoulos, MD||Northwell Health|