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NCT05334654·Not applicable·INTERVENTIONAL

Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

BivalirudinOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

58

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Apr 19, 2022

  2. Study start

    Apr 20, 2022

  3. Primary completion

    Jun 30, 2022

  4. Study completion

    Jul 30, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Aug 19, 2022

Outcomes

What the study measures.

Primary outcomes

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

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

Gas Exchange

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

Daily evaluation of oxygenation through arterial blood gases

Intensive Care Unit length of stay

Time frame · Up to 1 year

Number of days spent in Intensive Care Unit

Intensive Care Unit mortality

Time frame · Up to 1 year

Number of patients died during the Intensive Care Unit stay

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

Italy. Showing up to 24 locations stored in the fast local snapshot.

AOU Mater Domini

Catanzaro, Italy

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsBivalirudin trial dashboard →DatabaseBivalirudin database entry →ResearchBivalirudin research guide →