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Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

Primary Purpose

Acute Respiratory Failure, SARS CoV 2 Infection, Anticoagulants

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Enoxaparin Sodium
Bivalirudin
Sponsored by
University Magna Graecia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ratio between arterial partial pressure to inspired fraction of oxygen (PaO2/FiO2) < 200 mmHg
  • age equal or greater of 18 years/old
  • detection of coronavirus 2019 at the nasal swab;
  • need for endotracheal intubation and invasive mechanical ventilation

Exclusion Criteria:

  • known allergies to one of the two investigated drugs
  • presence of hematological diseases
  • pregnancy
  • recent (10 days) surgery
  • presence of active bleeding

Sites / Locations

  • AOU Mater Domini

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Enoxaparin sodium

Bivalirudin

Arm Description

Enoxaparin sodium twice daily, according to the renal function and clinical indication

Bivalirudin will be administered by continuous infusion, until day 7. Bivalirudin will be administered at dosage of 0,25 mg/kg in first 30 minutes, followed by continuous infusion of 0,2 mg/kg/h until 7 days. The infusion rate will be adjusted targeting a prothrombin time ratio of about 1.5.

Outcomes

Primary Outcome Measures

Time spent under invasive mechanical ventilation
number of days that patient would require invasive mechanical ventilation

Secondary Outcome Measures

Incidence of vein thrombosis and embolism
Number of patients with diagnosis of deep vein thrombosis and/or pulmonary embolism
Gas Exchange
Daily evaluation of oxygenation through arterial blood gases
Intensive Care Unit length of stay
Number of days spent in Intensive Care Unit
Intensive Care Unit mortality
Number of patients died during the Intensive Care Unit stay

Full Information

First Posted
April 13, 2022
Last Updated
August 17, 2022
Sponsor
University Magna Graecia
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1. Study Identification

Unique Protocol Identification Number
NCT05334654
Brief Title
Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients
Official Title
Bivalirudin Versus Enoxaparin for Anticoagulation in Critically Ill COVID-19 Patients: a Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Magna Graecia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, SARS CoV 2 Infection, Anticoagulants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Investigators and Outcome assessors will not take part in the care of patients. Data will be provide in anonymous form without any indication to the assigned treatment.
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enoxaparin sodium
Arm Type
Active Comparator
Arm Description
Enoxaparin sodium twice daily, according to the renal function and clinical indication
Arm Title
Bivalirudin
Arm Type
Experimental
Arm Description
Bivalirudin will be administered by continuous infusion, until day 7. Bivalirudin will be administered at dosage of 0,25 mg/kg in first 30 minutes, followed by continuous infusion of 0,2 mg/kg/h until 7 days. The infusion rate will be adjusted targeting a prothrombin time ratio of about 1.5.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin Sodium
Intervention Description
Enoxaparin will be subcutaneously administered at a dosage from 4000 to 8000 twice daily according
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Intervention Description
Bivalirudin will be intravenously administered to obtain an activated prothrombin time (aPTT) of 1.5 fold of the normal values.
Primary Outcome Measure Information:
Title
Time spent under invasive mechanical ventilation
Description
number of days that patient would require invasive mechanical ventilation
Time Frame
from randomization till 28 days after randomization
Secondary Outcome Measure Information:
Title
Incidence of vein thrombosis and embolism
Description
Number of patients with diagnosis of deep vein thrombosis and/or pulmonary embolism
Time Frame
from randomization till 28 days after randomization or ICU discharge
Title
Gas Exchange
Description
Daily evaluation of oxygenation through arterial blood gases
Time Frame
Every day till 28 days after randomization or ICU discharge
Title
Intensive Care Unit length of stay
Description
Number of days spent in Intensive Care Unit
Time Frame
Up to 1 year
Title
Intensive Care Unit mortality
Description
Number of patients died during the Intensive Care Unit stay
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ratio between arterial partial pressure to inspired fraction of oxygen (PaO2/FiO2) < 200 mmHg age equal or greater of 18 years/old detection of coronavirus 2019 at the nasal swab; need for endotracheal intubation and invasive mechanical ventilation Exclusion Criteria: known allergies to one of the two investigated drugs presence of hematological diseases pregnancy recent (10 days) surgery presence of active bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federico Longhini, MD
Organizational Affiliation
Magna Graecia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Mater Domini
City
Catanzaro
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The individual patients data will be shared only after the publication of the study on an international peer-reviewed journal and on scientific and intelligible proposal
IPD Sharing Time Frame
Data will be available after publication on an indexed international and peer-reviewed journal
IPD Sharing Access Criteria
Access will be allowed after contacting by email the principal investigator, by providing and intelligible and scientific proposal

Learn more about this trial

Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

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