ClinicalTrials.gov

History of Changes for Study: NCT04401293
Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients
Latest version (submitted December 1, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 21, 2020 None (earliest Version on record)
2 June 4, 2020 Contacts/Locations, Study Status and Study Description
3 December 1, 2020 Study Status
Comparison Format:

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Changes (Side-by-Side) for Study: NCT04401293
June 4, 2020 (v2) -- December 1, 2020 (v3)

Changes in: Study Status

Study Identification
Unique Protocol ID: 20-0340 20-0340
Brief Title: Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients
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) 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)
Secondary IDs:
Study Status
Record Verification: June 2020 June 2020
Overall Status: Recruiting Recruiting
Study Start: April 26, 2020 April 26, 2020
Primary Completion: October 22, 2020 [Anticipated ] April 26, 2021 [Anticipated ]
Study Completion: April 26, 2021 [Anticipated ] April 26, 2021 [Anticipated ]
First Submitted: May 20, 2020 May 20, 2020
First Submitted that
Met QC Criteria:
May 21, 2020 May 21, 2020
First Posted: May 26, 2020 [Actual ] May 26, 2020 [Actual ]
Last Update Submitted that
Met QC Criteria:
June 4, 2020 December 1, 2020
Last Update Posted: June 9, 2020 [Actual ] December 3, 2020 [Actual ]
Sponsor/Collaborators
Sponsor: Northwell Health Northwell Health
Responsible Party: Principal Investigator
Investigator: Alex Spyropoulos
Official Title: System Director - Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital
Affiliation: Northwell Health
Principal Investigator
Investigator: Alex Spyropoulos
Official Title: System Director - Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital
Affiliation: Northwell Health
Collaborators:
Oversight
U.S. FDA-regulated Drug: Yes Yes
U.S. FDA-regulated Device: No No
Product Exported from U.S.: No No
Data Monitoring: Yes Yes
Study Description
Brief Summary: The aim of this study is to test the hypothesis that prophylaxis of severe COVID-19 patients with treatment dose LMWH leads to better thromboembolic-free outcomes and associated complications during hospitalization than prophylaxis with institutional standard of care with prophylactic to intermediate-doses of UFH or LMWH The aim of this study is to test the hypothesis that prophylaxis of severe COVID-19 patients with treatment dose LMWH leads to better thromboembolic-free outcomes and associated complications during hospitalization than prophylaxis with institutional standard of care with prophylactic to intermediate-doses of UFH or LMWH
Detailed Description:

There are clinical data to support the observation that hospitalized acutely ill medical patients with severe viral pneumonitis/Acute Respiratory Distress Syndrome (ARDS), such as those with influenza H1N1 infection, have an over 23-fold increased risk for venous thromboembolism (VTE) - especially pulmonary embolism (PE) - with an overall 44% incidence of VTE in ARDS associated with H1N1 pneumonia. Multicenter studies from China report that key markers of inflammation and/or coagulopathy are associated with morbidity and increased mortality in COVID-19 patients. Elevated D-dimer levels (that are sometime greater than 4 or 6 times the upper limit of normal [ULN]) are strongly associated with mortality in patients with severe COVID-19 illness. Recent data also shows that mortality among COVID-19 patients is markedly higher in patients with elevated Troponin-T (TnT) levels than in patients with normal TnT levels. Recently a cohort of 81 patients retrospectively evaluated diagnosed with severe COVID-19 pneumonia and reported a lower extremity VTE incidence of 25% (20/81) and a mortality of 40% (8/20) in the presence of VTE. Reported a case of bilateral pulmonary embolism in a 75 year old woman diagnosed with severe COVID-19, in the absence of predisposing risk factors and a negative lower extremity US. Lastly the investigated use of Tissue Plasminogen Activator (tPA) in the treatment of COVID-19 associated ARDS and reported promising, but transient, results in terms of pulmonary function improvement. It appears that either the SARS-CoV2 infection itself induces a hypercoagulable state, possibly by hypofibrinolytic mechanisms, or the cytokine storm in COVID-19 patients with severe disease induces a prothrombotic state, which leads to clinical deterioration, hypoxia and hemodynamic instability secondary to thromboembolic phenomena and potentially cardiac ischemia. Preliminary data from Northwell Health System, which has one of the largest populations of hospitalized COVID-19 patients in the US, reveals a positivity rate for deep vein thrombosis (DVT) of 40% of those COVID-19 patients screened by Doppler compression ultrasonography of the lower extremities.

Heparin has been shown to have anti-inflammatory and immunomodulatory properties in addition to its anticoagulation effect, which could play a beneficial role in sepsis. In addition, there is in vitro evidence that the large negatively charged sulfated glycosaminoglycans of unfractionated heparin may act as an alternate ligand for the SARS-CoV2 receptor irrespective of ACE2. Whether this in vitro evidence supports the role of a protective or deleterious mechanism in COVID-19 infection is not known. However, an early report with empiric use of treatment dose unfractionated heparin (UFH) in ARDS from a different viral family, influenza H1N1, revealed that H1N1 ARDS patients under systemic anticoagulation had 33-fold fewer VTE events than those treated given prophylactic doses of UFH/low-molecular weight heparin (LMWH) thromboprophylaxis. Very recent evidence suggests that therapy with prophylactic to intermediate doses of the LMWH enoxaparin (30mg to 60mg QD) in severe hospitalized COVID-19 patents with a SIC score ≥ 4 or D-dimer (Dd) > 6 X ULN improves outcomes and prognosis. All-cause mortality at 28 days was reduced from 64.2% to 40.0% in those patients with a SIC score ≥ 4 (p=0.029), and from 52.4% to 32.8% in those patients with an elevated Dd > 6 x ULN (P=0.017). Notably, Klok and colleagues investigated 184 ICU patients infected with COVID-19 and reported a 13% mortality rate, a relatively high incidence of CTPA- or ultrasonography-confirmed VTE rate (27%), and arterial thrombotic events (3.7%) despite the use of standard dose thromboprophylaxis. Postulated mechanisms for the improved prognosis with the use of treatment doses of LMWH in the sick COVID-19 population include the decrease in the risk of microthrombi, especially in the pulmonary vasculature, which can lead to hypoxemia, pulmonary vasoconstriction and right ventricular dysfunction as well as the decrease in the risk of progression to disseminated intravascular coagulopathy as a contributor to the high mortality seen in these patients.

The optimal dose of heparin (either LMWH or UFH) in hospitalized COVID-19 patients is unknown, as patients on conventional prophylactic dose heparin (UFH or LMWH) as supported by international guidance statements on hospitalized COVID-19 patients appear to remain at risk for thromboembolic events. There is data to support improved efficacy with treatment doses of twice daily enoxaparin versus once-daily weight-adjusted enoxaparin for the management of VTE, especially with large thrombus burden. There is also long-standing data to support that treatment-dose heparin can reduce major cardiovascular events. Our current standard of care in our 24 hospital Northwell Health System, which has a very large hospitalized COVID-19 patient population, is to use Lovenox 40mg SQ QD for patients with a BMI < 30 and Creatinine Clearance (CrCl) > 15ml/min, Lovenox 40mg SQ BID for patients with a BMI > 30 and CrCl > 15ml/min, and UFH 5000U SQ BID or TID in patients with a CrCl < 15ml/min and BMI < 30 and UFH 7500U SQ BID or TID with a CrCl < 15ml/min and BMI > 30. Large healthcare institutions in the US and elsewhere have protocols for in-patient thromboprophylaxis ranging from prophylactic-to-intermediate dose UFH or LMWH for the management of patients with COVID-19 associated coagulopathy. The aim of this study is to test the hypothesis that prophylaxis of severe COVID-19 patients with treatment dose LMWH leads to better thromboembolic-free outcomes and associated complications during hospitalization than prophylaxis with institutional standard of care with prophylactic to intermediate-doses of UFH or LMWH.

There are clinical data to support the observation that hospitalized acutely ill medical patients with severe viral pneumonitis/Acute Respiratory Distress Syndrome (ARDS), such as those with influenza H1N1 infection, have an over 23-fold increased risk for venous thromboembolism (VTE) - especially pulmonary embolism (PE) - with an overall 44% incidence of VTE in ARDS associated with H1N1 pneumonia. Multicenter studies from China report that key markers of inflammation and/or coagulopathy are associated with morbidity and increased mortality in COVID-19 patients. Elevated D-dimer levels (that are sometime greater than 4 or 6 times the upper limit of normal [ULN]) are strongly associated with mortality in patients with severe COVID-19 illness. Recent data also shows that mortality among COVID-19 patients is markedly higher in patients with elevated Troponin-T (TnT) levels than in patients with normal TnT levels. Recently a cohort of 81 patients retrospectively evaluated diagnosed with severe COVID-19 pneumonia and reported a lower extremity VTE incidence of 25% (20/81) and a mortality of 40% (8/20) in the presence of VTE. Reported a case of bilateral pulmonary embolism in a 75 year old woman diagnosed with severe COVID-19, in the absence of predisposing risk factors and a negative lower extremity US. Lastly the investigated use of Tissue Plasminogen Activator (tPA) in the treatment of COVID-19 associated ARDS and reported promising, but transient, results in terms of pulmonary function improvement. It appears that either the SARS-CoV2 infection itself induces a hypercoagulable state, possibly by hypofibrinolytic mechanisms, or the cytokine storm in COVID-19 patients with severe disease induces a prothrombotic state, which leads to clinical deterioration, hypoxia and hemodynamic instability secondary to thromboembolic phenomena and potentially cardiac ischemia. Preliminary data from Northwell Health System, which has one of the largest populations of hospitalized COVID-19 patients in the US, reveals a positivity rate for deep vein thrombosis (DVT) of 40% of those COVID-19 patients screened by Doppler compression ultrasonography of the lower extremities.

Heparin has been shown to have anti-inflammatory and immunomodulatory properties in addition to its anticoagulation effect, which could play a beneficial role in sepsis. In addition, there is in vitro evidence that the large negatively charged sulfated glycosaminoglycans of unfractionated heparin may act as an alternate ligand for the SARS-CoV2 receptor irrespective of ACE2. Whether this in vitro evidence supports the role of a protective or deleterious mechanism in COVID-19 infection is not known. However, an early report with empiric use of treatment dose unfractionated heparin (UFH) in ARDS from a different viral family, influenza H1N1, revealed that H1N1 ARDS patients under systemic anticoagulation had 33-fold fewer VTE events than those treated given prophylactic doses of UFH/low-molecular weight heparin (LMWH) thromboprophylaxis. Very recent evidence suggests that therapy with prophylactic to intermediate doses of the LMWH enoxaparin (30mg to 60mg QD) in severe hospitalized COVID-19 patents with a SIC score ≥ 4 or D-dimer (Dd) > 6 X ULN improves outcomes and prognosis. All-cause mortality at 28 days was reduced from 64.2% to 40.0% in those patients with a SIC score ≥ 4 (p=0.029), and from 52.4% to 32.8% in those patients with an elevated Dd > 6 x ULN (P=0.017). Notably, Klok and colleagues investigated 184 ICU patients infected with COVID-19 and reported a 13% mortality rate, a relatively high incidence of CTPA- or ultrasonography-confirmed VTE rate (27%), and arterial thrombotic events (3.7%) despite the use of standard dose thromboprophylaxis. Postulated mechanisms for the improved prognosis with the use of treatment doses of LMWH in the sick COVID-19 population include the decrease in the risk of microthrombi, especially in the pulmonary vasculature, which can lead to hypoxemia, pulmonary vasoconstriction and right ventricular dysfunction as well as the decrease in the risk of progression to disseminated intravascular coagulopathy as a contributor to the high mortality seen in these patients.

The optimal dose of heparin (either LMWH or UFH) in hospitalized COVID-19 patients is unknown, as patients on conventional prophylactic dose heparin (UFH or LMWH) as supported by international guidance statements on hospitalized COVID-19 patients appear to remain at risk for thromboembolic events. There is data to support improved efficacy with treatment doses of twice daily enoxaparin versus once-daily weight-adjusted enoxaparin for the management of VTE, especially with large thrombus burden. There is also long-standing data to support that treatment-dose heparin can reduce major cardiovascular events. Our current standard of care in our 24 hospital Northwell Health System, which has a very large hospitalized COVID-19 patient population, is to use Lovenox 40mg SQ QD for patients with a BMI < 30 and Creatinine Clearance (CrCl) > 15ml/min, Lovenox 40mg SQ BID for patients with a BMI > 30 and CrCl > 15ml/min, and UFH 5000U SQ BID or TID in patients with a CrCl < 15ml/min and BMI < 30 and UFH 7500U SQ BID or TID with a CrCl < 15ml/min and BMI > 30. Large healthcare institutions in the US and elsewhere have protocols for in-patient thromboprophylaxis ranging from prophylactic-to-intermediate dose UFH or LMWH for the management of patients with COVID-19 associated coagulopathy. The aim of this study is to test the hypothesis that prophylaxis of severe COVID-19 patients with treatment dose LMWH leads to better thromboembolic-free outcomes and associated complications during hospitalization than prophylaxis with institutional standard of care with prophylactic to intermediate-doses of UFH or LMWH.

Conditions
Conditions: Sars-CoV2
COVID
Sars-CoV2
COVID
Keywords: COVID-19
Anticoagulation
Heparin
Coronavirus
Thrombosis
COVID-19
Anticoagulation
Heparin
Coronavirus
Thrombosis
Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Phase 3Phase 3
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 22
Masking: Triple (Participant, Care Provider, Investigator)Triple (Participant, Care Provider, Investigator)
Allocation: RandomizedRandomized
Enrollment: 308 [Anticipated ] 308 [Anticipated ]
Arms and Interventions
Arms Assigned Interventions
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.
Drug: Enoxaparin
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
Other Names:
  • Unfractionated heparin
  • dalteparin
Outcome Measures
Primary Outcome Measures:
1. Composite outcome of arterial thromboembolic events, venous thromboembolic events and all-cause mortality at 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.

[Time Frame: Day 30 ± 2 days ]
Composite outcome of arterial thromboembolic events, venous thromboembolic events and all-cause mortality at 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.

[Time Frame: Day 30 ± 2 days ]
Secondary Outcome Measures:
2. Major bleeding
Risk of major bleeding defined using the International Society of Thrombosis and Haemostasis (ISTH) criteria

[Time Frame: Day 30 ± 2 days ]
Major bleeding
Risk of major bleeding defined using the International Society of Thrombosis and Haemostasis (ISTH) criteria

[Time Frame: Day 30 ± 2 days ]
3. Composite outcome of arterial thromboembolic events, venous thromboembolic events and all-cause mortality at Hospital 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

[Time Frame: Day 10 + 4 ]
Composite outcome of arterial thromboembolic events, venous thromboembolic events and all-cause mortality at Hospital 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

[Time Frame: Day 10 + 4 ]
4. Sepsis-induced coagulopathy (SIC) score

Sepsis-induced coagulopathy (SIC) score based on ISTH guidelines.

  • Platelets, K/uL (thousands per microliter) [0-2]
  • INR (International Normalized Ratio) [0-2]
  • D-Dimer Levels, ng/mL [0-3]
  • Fibrinogen, mg/dL [0-1]

Calculated (SIC) scores greater or equal to 4 predicted higher mortality rates within 30 days and greater risk of pulmonary embolism.



[Time Frame: Day 30 ± 2 days. ]
Sepsis-induced coagulopathy (SIC) score

Sepsis-induced coagulopathy (SIC) score based on ISTH guidelines.

  • Platelets, K/uL (thousands per microliter) [0-2]
  • INR (International Normalized Ratio) [0-2]
  • D-Dimer Levels, ng/mL [0-3]
  • Fibrinogen, mg/dL [0-1]

Calculated (SIC) scores greater or equal to 4 predicted higher mortality rates within 30 days and greater risk of pulmonary embolism.



[Time Frame: Day 30 ± 2 days. ]
5. Progression to Acute Respiratory Distress Syndrome (ARDS)
Progression to Acute Respiratory Distress Syndrome (ARDS) based on monitoring of patient conditions.

[Time Frame: Day 30 ± 2 days. ]
Progression to Acute Respiratory Distress Syndrome (ARDS)
Progression to Acute Respiratory Distress Syndrome (ARDS) based on monitoring of patient conditions.

[Time Frame: Day 30 ± 2 days. ]
6. Need for Intubation
Need for Intubation will be based on monitoring of patient conditions.

[Time Frame: Day 30 ± 2 days. ]
Need for Intubation
Need for Intubation will be based on monitoring of patient conditions.

[Time Frame: Day 30 ± 2 days. ]
7. Re-hospitalization
Need for Re-hospitalization will be based on monitoring of patient conditions.

[Time Frame: Day 30 ± 2 days. ]
Re-hospitalization
Need for Re-hospitalization will be based on monitoring of patient conditions.

[Time Frame: Day 30 ± 2 days. ]
Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age:
Sex: All All
Gender Based:
Accepts Healthy Volunteers: NoNo
Criteria:

Inclusion Criteria:

  1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
  2. Understands and agrees to comply with planned study procedures.
  3. Male or non-pregnant female adult ≥18 years of age at time of enrollment.
  4. Subject consents to randomization within 72 hours of hospital admission or transfer from another facility within 72 hours of index presentation.
  5. Subjects with a positive COVID-19 diagnosis by nasal swab or serologic testing.
  6. Hospitalized with a requirement for supplemental oxygen.
  7. Have:
    • Either a D- Dimer > 4.0 X ULN, OR
    • Sepsis-induced coagulopathy (SIC) score of ≥4

Exclusion Criteria:

  1. Indications for therapeutic anticoagulation
  2. Absolute contraindication to anticoagulation including:
    1. active bleeding,
    2. recent (within 1 month) history of bleed,
    3. dual (but not single) antiplatelet therapy,
    4. active gastrointestinal and intracranial cancer,
    5. a history of bronchiectasis or pulmonary cavitation,
    6. Hepatic failure with a baseline INR > 1.5,
    7. CrCl < 15ml/min,
    8. a platelet count < 25,000,
    9. a history of heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies,
    10. contraindications to enoxaparin including a hypersensitivity to enoxaparin sodium, hypersensitivity to heparin or pork products, hypersensitivity to benzyl alcohol,
    11. pregnant female,
    12. inability to give or designate to give informed consent,
    13. participation in another blinded trial of investigational drug therapy for COVID-19

Inclusion Criteria:

  1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
  2. Understands and agrees to comply with planned study procedures.
  3. Male or non-pregnant female adult ≥18 years of age at time of enrollment.
  4. Subject consents to randomization within 72 hours of hospital admission or transfer from another facility within 72 hours of index presentation.
  5. Subjects with a positive COVID-19 diagnosis by nasal swab or serologic testing.
  6. Hospitalized with a requirement for supplemental oxygen.
  7. Have:
    • Either a D- Dimer > 4.0 X ULN, OR
    • Sepsis-induced coagulopathy (SIC) score of ≥4

Exclusion Criteria:

  1. Indications for therapeutic anticoagulation
  2. Absolute contraindication to anticoagulation including:
    1. active bleeding,
    2. recent (within 1 month) history of bleed,
    3. dual (but not single) antiplatelet therapy,
    4. active gastrointestinal and intracranial cancer,
    5. a history of bronchiectasis or pulmonary cavitation,
    6. Hepatic failure with a baseline INR > 1.5,
    7. CrCl < 15ml/min,
    8. a platelet count < 25,000,
    9. a history of heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies,
    10. contraindications to enoxaparin including a hypersensitivity to enoxaparin sodium, hypersensitivity to heparin or pork products, hypersensitivity to benzyl alcohol,
    11. pregnant female,
    12. inability to give or designate to give informed consent,
    13. participation in another blinded trial of investigational drug therapy for COVID-19
Contacts/Locations
Central Contact: Damian N Inlall, CCRC
Telephone: (516) 600-1482
Email: dinlall@northwell.edu
Damian N Inlall, CCRC
Telephone: (516) 600-1482
Email: dinlall@northwell.edu
Central Contact Backup: Dimitrios Giannis, MD
Telephone: (516) 600-1434
Email: dgiannis@northwell.edu
Dimitrios Giannis, MD
Telephone: (516) 600-1434
Email: dgiannis@northwell.edu
Study Officials: Alex C Spyropoulos, MD
Principal Investigator
Northwell Health
Alex C Spyropoulos, MD
Principal Investigator
Northwell Health
Locations: United States, New JerseyUnited States, New Jersey
Beth Israel Newark
[Recruiting]
Newark, New Jersey, United States, 07112
Contact: Kevin Molina 973-926-8451 kevin.molina@rwjbh.org
Principal Investigator: Marc Cohen, MD
Beth Israel Newark
[Recruiting]
Newark, New Jersey, United States, 07112
Contact: Kevin Molina 973-926-8451 kevin.molina@rwjbh.org
Principal Investigator: Marc Cohen, MD
United States, New YorkUnited States, New York
Southside Hospital
[Recruiting]
Bay Shore, New York, United States, 11706
Contact: Barbara Shannon, RN 631-968-3016 bshannon@northwell.edu
Contact: Lisa Lumley, RN 631-647-3840 llumley@northwell.edu
Sub-Investigator: Gulru Sharifova, MD
Sub-Investigator: Aaron Harrison, MD
Sub-Investigator: Luis Gruberg, MD
Sub-Investigator: Puneet Gandotra, MD
Southside Hospital
[Recruiting]
Bay Shore, New York, United States, 11706
Contact: Barbara Shannon, RN 631-968-3016 bshannon@northwell.edu
Contact: Lisa Lumley, RN 631-647-3840 llumley@northwell.edu
Sub-Investigator: Gulru Sharifova, MD
Sub-Investigator: Aaron Harrison, MD
Sub-Investigator: Luis Gruberg, MD
Sub-Investigator: Puneet Gandotra, MD
Huntington Hospital
[Recruiting]
Huntington, New York, United States, 11743
Contact: Dana Kuziw, RN 631-351-2798 dkuziw@northwell.edu
Contact: Jane Hubert, RN 631-351-2798 jhubert@northwell.edu
Sub-Investigator: Paul Maccaro, MD
Sub-Investigator: Adrian Popp, MD
Sub-Investigator: George Surguladze, MD
Sub-Investigator: Cynthia Price, NP
Huntington Hospital
[Recruiting]
Huntington, New York, United States, 11743
Contact: Dana Kuziw, RN 631-351-2798 dkuziw@northwell.edu
Contact: Jane Hubert, RN 631-351-2798 jhubert@northwell.edu
Sub-Investigator: Paul Maccaro, MD
Sub-Investigator: Adrian Popp, MD
Sub-Investigator: George Surguladze, MD
Sub-Investigator: Cynthia Price, NP
Lenox Hill Hospital
[Recruiting]
New York, New York, United States, 10075
Contact: Christina Brennan, MD 516-881-7083 cbrennan@northwell.edu
Sub-Investigator: Andrea Mignatti, MD
Sub-Investigator: Eugenia Gianos, MD
Sub-Investigator: Jeremy Jacobson, MD
Sub-Investigator: Nazish Ilyas, MD
Lenox Hill Hospital
[Recruiting]
New York, New York, United States, 10075
Contact: Christina Brennan, MD 516-881-7083 cbrennan@northwell.edu
Sub-Investigator: Andrea Mignatti, MD
Sub-Investigator: Eugenia Gianos, MD
Sub-Investigator: Jeremy Jacobson, MD
Sub-Investigator: Nazish Ilyas, MD
Long Island Jewish Medical Center
[Recruiting]
Queens, New York, United States, 11040
Contact: Richard Dima, MD 516-881-7064 rdima@northwell.edu
Sub-Investigator: Mark Goldin, MD
Sub-Investigator: Janice Wang, MD
Sub-Investigator: Negin Hajizadeh, MD
Sub-Investigator: Mangala Narasimhan, MD
Long Island Jewish Medical Center
[Recruiting]
Queens, New York, United States, 11040
Contact: Richard Dima, MD 516-881-7064 rdima@northwell.edu
Sub-Investigator: Mark Goldin, MD
Sub-Investigator: Janice Wang, MD
Sub-Investigator: Negin Hajizadeh, MD
Sub-Investigator: Mangala Narasimhan, MD
Staten Island University Hospital
[Recruiting]
Staten Island, New York, United States, 10309
Contact: Melissa Panzo, RN 718-226-6629 mpanzo1@northwell.edu
Contact: Sean Taylor 718-226-6591 staylor12@northwell.edu
Sub-Investigator: Wassim Diab, MD
Sub-Investigator: John Flynt, MD
Sub-Investigator: Phyllis Suen, MD
Sub-Investigator: Michael Krzyzak, MD
Staten Island University Hospital
[Recruiting]
Staten Island, New York, United States, 10309
Contact: Melissa Panzo, RN 718-226-6629 mpanzo1@northwell.edu
Contact: Sean Taylor 718-226-6591 staylor12@northwell.edu
Sub-Investigator: Wassim Diab, MD
Sub-Investigator: John Flynt, MD
Sub-Investigator: Phyllis Suen, MD
Sub-Investigator: Michael Krzyzak, MD
IPDSharing
Plan to Share IPD: No No
References
Citations:
Links:
Description: Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the Coronavirus Disease 2019 (COVID-19) Pandemic
Description: Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the Coronavirus Disease 2019 (COVID-19) Pandemic
Description: Empirical systemic anticoagulation is associated with decreased venous thromboembolism in critically ill influenza A H1N1 acute respiratory distress syndrome patients
Description: Empirical systemic anticoagulation is associated with decreased venous thromboembolism in critically ill influenza A H1N1 acute respiratory distress syndrome patients
Description: Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia
Description: Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia
Description: Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy
Description: Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy
Description: Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19)
Description: Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19)
Description: Prevalence of venous thromboembolism in patients with severe novel coronavirus pneumonia
Description: Prevalence of venous thromboembolism in patients with severe novel coronavirus pneumonia
Description: Acute pulmonary embolism and COVID-19 pneumonia: a random association
Description: Acute pulmonary embolism and COVID-19 pneumonia: a random association
Description: Tissue Plasminogen Activator (tPA) Treatment for COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS): A Case Series
Description: Tissue Plasminogen Activator (tPA) Treatment for COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS): A Case Series
Description: Pharmacology of Heparin and Related Drugs
Description: Pharmacology of Heparin and Related Drugs
Description: Incidence of thrombotic complications in critically ill ICU patients with COVID-19
Description: Incidence of thrombotic complications in critically ill ICU patients with COVID-19
Description: Hypothesis for potential pathogenesis of SARS-CoV-2 infection-a review of immune changes in patients with viral pneumonia
Description: Hypothesis for potential pathogenesis of SARS-CoV-2 infection-a review of immune changes in patients with viral pneumonia
Description: Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes
Description: Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes
Description: Emergence of Institutional Antithrombotic Protocols for Coronavirus 2019
Description: Emergence of Institutional Antithrombotic Protocols for Coronavirus 2019
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