Clinical trial
COVID-19-associated Coagulopathy: Safety and Efficacy of Prophylactic Anticoagulation Therapy in Hospitalized Adults With COVID-19
Name
202004235
Description
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).
Trial arms
Trial start
2020-05-06
Estimated PCD
2021-04-16
Trial end
2021-04-16
Status
Completed
Phase
Early phase I
Treatment
Intermediate dose thromboprophylaxis
2) Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI\<30kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).
Arms:
Interventional
Other names:
intermediate dose Enoxaparin
Standard of Care thromboprophylaxis
Patients randomized to the standard of care arm will receive standard prophylactic dose enoxaparin (40 mg subcutaneously daily if BMI \<30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30 kg/m2).
Arms:
Standard of Care
Size
176
Primary endpoint
Mortality
30 Days post intervention
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a multi-center, randomized, open-label study comparing standard prophylactic dose enoxaparin (40 mg SC daily or 30 or 40 mg SC twice daily if BMI ≥30kg/m2; standard of care arm) versus intermediate-dose enoxaparin (1 mg/kg SC daily or 0.5 mg/kg SC twice daily if BMI≥30kg/m2; intervention arm) in hospitalized patients with laboratory-confirmed SARS-CoV-2 infection.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 176, 'type': 'ACTUAL'}}
Updated at
2023-03-01
1 organization
2 products
1 indication
Organization
University of IowaIndication
COVID-19 Associated Coagulopathy