drugset / Trial / NCT04367831

Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19

NCT04367831

Phase 4 Completed 94 enrolled Columbia University
RandomizedParallel-groupSingle-blindTreatment

Summary

This study is being conducted to assess the effectiveness of intermediate versus prophylactic doses of anticoagulation (blood thinners) in patients critically ill with COVID-19 in the intensive care units (ICUs) throughout the hospital. Anticoagulation is part of the patient's usual standard of care but determining the dose of anticoagulation is based on physician preference. The investigators are conducting this study (a randomized trial with adaptive design employing cluster randomization) with the support of all of the ICUs to collect data in order to determine what should be the standard of care in terms of anticoagulation in these critically ill patients. The patients care will not be altered other than the choice of anticoagulation (both approved and used throughout the hospital as standard of care) based on the ICU bed they are assigned. Patient data will be collected until discharge.

Timeline

Start
2020-05-02
Primary completion
2021-05-12
Completion
2021-05-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Enoxaparin sodium Other / unclassified 1 mg/kg Subcutaneous
Comparator Enoxaparin sodium Other / unclassified 40 mg Subcutaneous
Comparator Enoxaparin sodium Other / unclassified 60 mg Subcutaneous
Subject Heparin Other / unclassified 10 iu/kg Subcutaneous
Subject Heparin Other / unclassified 5000 iu Subcutaneous
Subject Heparin Other / unclassified 7500 iu Subcutaneous