NCT04406389

Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial)

InterMediate ProphylACtic Versus Therapeutic Dose Anticoagulation in Critically Ill Patients With COVID-19: A Prospective Randomized Study (The IMPACT Trial)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if therapeutic dose anticoagulation (experimental group) improves 30-day mortality in participants with COVID-19 compared to those patients receiving the intermediate dose prophylaxis (control group). Following screening, subjects will be randomized 1:1 to intermediate dose prophylaxis or therapeutic dose anticoagulation treatment arms.Treatment will continue for 28 days, followed by a 6 month follow-up period.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Enoxaparin sodium	Intermediate Dose Prophylaxis Arm: 0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min --OR-- 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min Therapeutic Dose Anticoagulation Arm: 1 mg/kg subcutaneously every 12 hours
DRUG	Unfractionated heparin	Intermediate Dose Prophylaxis Arm: 7,500 units subcutaneously every 8 hours Therapeutic Dose Anticoagulation Arm: Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
DRUG	Fondapariniux	Intermediate Dose Prophylaxis Arm: 2.5 mg daily subcutaneously Therapeutic Dose Anticoagulation Arm: Dose by weight: * If greater than or equal to 100 kg: 10 mg daily * If less than 100 kg but greater than or equal to 50 kg: 7.5 mg daily * If less than 50 kg: 5 mg daily
DRUG	Argatroban	Therapeutic Dose Anticoagulation Arm: Dosed according to institutional protocol

Timeline

• Start date: 2020-10-13
• Primary completion: 2021-04-17
• Completion: 2022-04-21
• First posted: 2020-05-28
• Last updated: 2023-09-21
• Results posted: 2023-09-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study