Status:
COMPLETED
Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients
Lead Sponsor:
Northwell Health
Conditions:
Sars-CoV2
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 h...
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...
Eligibility Criteria
Inclusion
- Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- Understands and agrees to comply with planned study procedures.
- Male or non-pregnant female adult ≥18 years of age at time of enrollment.
- Subject consents to randomization within 72 hours of hospital admission or transfer from another facility within 72 hours of index presentation.
- Subjects with a positive COVID-19 diagnosis by nasal swab or serologic testing.
- Hospitalized with a requirement for supplemental oxygen.
- Have:
- Either a D- Dimer \> 4.0 X ULN, OR
- Sepsis-induced coagulopathy (SIC) score of ≥4
Exclusion
- Indications for therapeutic anticoagulation
- Absolute contraindication to anticoagulation including:
- active bleeding,
- recent (within 1 month) history of bleed,
- dual (but not single) antiplatelet therapy,
- active gastrointestinal and intracranial cancer,
- a history of bronchiectasis or pulmonary cavitation,
- Hepatic failure with a baseline INR \> 1.5,
- CrCl \< 15ml/min,
- a platelet count \< 25,000,
- a history of heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies,
- contraindications to enoxaparin including a hypersensitivity to enoxaparin sodium, hypersensitivity to heparin or pork products, hypersensitivity to benzyl alcohol,
- pregnant female,
- inability to give or designate to give informed consent,
- participation in another blinded trial of investigational drug therapy for COVID-19
Key Trial Info
Start Date :
April 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2021
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT04401293
Start Date
April 26 2020
End Date
May 14 2021
Last Update
November 22 2021
Active Locations (6)
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1
Beth Israel Newark
Newark, New Jersey, United States, 07112
2
Southside Hospital
Bay Shore, New York, United States, 11706
3
Huntington Hospital
Huntington, New York, United States, 11743
4
Lenox Hill Hospital
New York, New York, United States, 10075