Phase 4
N=176
Covid-19 Associated Coagulopathy
COVID 19 Associated Coagulopathy
Bottom Line
View on ClinicalTrials.gov: NCT04360824 ↗Enrolled (actual)
176
Serious AEs
36.4%
Results posted
Mar 2023
Primary outcome: Primary: Mortality — 18; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Intermediate dose thromboprophylaxis (Drug); Standard of Care thromboprophylaxis (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Iowa
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality |
18; 13 | — |
| SECONDARY Number of Participants With Acute Kidney Injury |
15; 11 | — |
| SECONDARY Number of Participants With Arterial Thrombosis |
3; 5 | — |
| SECONDARY Number of Participants With Venous Thrombosis |
6; 7 | — |
| SECONDARY Number of Participants With Major Bleeding |
2; 2 | — |
| SECONDARY Number of Participants With Minor Bleeding |
6; 6 | — |
Summary
This prospective, randomized, open-label, multi-center interventional study is designed to compare the safety and efficacy of two LMWH dosing protocols in patients admitted to the University of Iowa Hospitals with COVID-19 who meet the modified ISTH Overt DIC criteria score ≥3. Patients will be randomized to standard prophylactic dose LMWH (standard of care arm) or intermediate-dose LMWH (intervention arm).
Eligibility Criteria
Inclusion Criteria
- Laboratory confirmed SARS-CoV-2 infection
- Age ≥18 years
- Requires hospital admission for further clinical management
- Modified ISTH Overt DIC score ≥ 3
Exclusion Criteria
- Indication for full therapeutic-dose anticoagulation
- Acute venous thromboembolism (deep vein thrombosis or pulmonary embolism) within prior 3 months
- Acute cardiovascular event within prior 3 months
- Acute stroke (ischemic or hemorrhagic) within prior 3 months
- Active major bleeding
- Severe thrombocytopenia (<25,000/mm3)
- Increased risk of bleeding, as assessed by the investigator
- Acute or chronic renal insufficiency with Creatinine Clearance < 30 ml/min calculated by the modified Cockcroft and Gault formula
- Weight < 40 kg
- Known allergies to ingredients contained in enoxaparin, allergy to heparin products or history of heparin induced thrombocytopenia
Data sourced from ClinicalTrials.gov (NCT04360824). 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.