Phase 3
N=257
Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients
Sars-CoV2 · COVID
Bottom Line
View on ClinicalTrials.gov: NCT04401293 ↗Enrolled (actual)
257
Serious AEs
0.8%
Results posted
Nov 2021
Primary outcome: Primary: Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Day 30 ± 2 Days. — 25; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Enoxaparin (Drug); Prophylactic/Intermediate Dose Enoxaparin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Day 30 ± 2 Days. |
25; 31 | — |
| SECONDARY Major Bleeding |
6; 2 | — |
| SECONDARY Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Hospital Day 10 + 4 |
2; 3 | — |
| SECONDARY Sepsis-induced Coagulopathy (SIC) Score |
2.35; 2.31 | — |
| SECONDARY Progression to Acute Respiratory Distress Syndrome (ARDS) |
11; 6 | — |
| SECONDARY Need for Intubation |
17; 21 | — |
| SECONDARY Re-hospitalization |
1; 3 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04401293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.