Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

NCT05334654 | Completed DMC

• 1 other identifier: Bivalirudin COVID-19
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure; SARS CoV 2 Infection; Anticoagulants

Outcome Measures

Primary Outcomes (1)

• Time spent under invasive mechanical ventilation

  number of days that patient would require invasive mechanical ventilation

  from randomization till 28 days after randomization

Secondary Outcomes (4)

• Incidence of vein thrombosis and embolism

  from randomization till 28 days after randomization or ICU discharge

• Gas Exchange

  Every day till 28 days after randomization or ICU discharge

• Intensive Care Unit length of stay

  Up to 1 year

• Intensive Care Unit mortality

  Up to 1 year

Study Arms (2)

Enoxaparin sodium

ACTIVE COMPARATOR

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

Drug: Enoxaparin Sodium

Bivalirudin

EXPERIMENTAL

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.

Drug: Bivalirudin

Interventions

Enoxaparin Sodium DRUG

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

Enoxaparin sodium

Bivalirudin DRUG

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

Bivalirudin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

AOU Mater Domini

Catanzaro, Italy

Location

MeSH Terms

Conditions

COVID-19

Interventions

enoxaparin sodium; bivalirudin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Federico Longhini, MD

  Magna Graecia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Intensive Care and Anesthesia Department

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 19, 2022
• Study Start: April 20, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after publication on an indexed international and peer-reviewed journal
• Access Criteria: Access will be allowed after contacting by email the principal investigator, by providing and intelligible and scientific proposal

Locations

IT (1)