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Completed

NCT Number: NCT05334654

Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

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.

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Key information

Conditions

Acute Respiratory Failure Anticoagulants COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS CoV 2 Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Mater Domini

Catanzaro, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enoxaparin sodium

Drug

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

Bivalirudin

Drug

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

Primary outcomes

  1. Time spent under invasive mechanical ventilation

    Time frame: from randomization till 28 days after randomization

    number of days that patient would require invasive mechanical ventilation

Secondary outcomes

  1. Incidence of vein thrombosis and embolism

    Time frame: from randomization till 28 days after randomization or ICU discharge

    Number of patients with diagnosis of deep vein thrombosis and/or pulmonary embolism

  2. Gas Exchange

    Time frame: Every day till 28 days after randomization or ICU discharge

    Daily evaluation of oxygenation through arterial blood gases

  3. Intensive Care Unit length of stay

    Time frame: Up to 1 year

    Number of days spent in Intensive Care Unit

  4. Intensive Care Unit mortality

    Time frame: Up to 1 year

    Number of patients died during the Intensive Care Unit stay

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

Bivalirudin Versus Enoxaparin for Anticoagulation in Critically Ill COVID-19 Patients: a Pilot Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2022
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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