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Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

NCT05334654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-08-19

No results posted yet for this study

Summary

Coronavirus Disease (COVID-19) is characterized by a hypercoagulable state, sometimes difficult to be managed with heparin. Bivalirudin, a member of the direct thrombin inhibitor drug class, offers potential advantages compared to heparin, including to its ability to exert its effect by directly attaching to and inhibiting freely circulating and fibrin-bound thrombin.

Investigators have therefore designed this pilot open-label randomized controlled trial to assess if a off-label infusion of bivalirudin may reduce thrombosis, mortality, Intensive Care Unit (ICU) length of stay and increase ventilator free days of patients admitted in ICU for acute respiratory failure due to COVID-19, as compared to first-line treatment with heparin.

Conditions

  • Acute Respiratory Failure
  • SARS CoV 2 Infection
  • Anticoagulants

Interventions

DRUG

Enoxaparin Sodium

Enoxaparin will be subcutaneously administered at a dosage from 4000 to 8000 twice daily according

DRUG

Bivalirudin

Bivalirudin will be intravenously administered to obtain an activated prothrombin time (aPTT) of 1.5 fold of the normal values.

Sponsors & Collaborators

  • University Magna Graecia

    lead OTHER

Principal Investigators

  • Federico Longhini, MD · Magna Graecia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-20
Primary Completion
2022-06-30
Completion
2022-07-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05334654 on ClinicalTrials.gov