Acute Respiratory FailureNCT05334654
Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients
A study testing Enoxaparin Sodium and Bivalirudin in people with Acute Respiratory Failure and SARS CoV 2 Infection, run by University Magna Graecia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, SARS CoV 2 Infection, Anticoagulants
- What is being tested?
- Enoxaparin Sodium and Bivalirudin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteItaly
- Study dates
- 20 Apr 2022to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- known allergies to one of the two investigated drugs
- presence of hematological diseases
- pregnancy
- recent (10 days) surgery
- presence of active bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bivalirudin Versus Enoxaparin for Anticoagulation in Critically Ill COVID-19 Patients: a Pilot Randomized Controlled Trial
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.
- Being tested
- Enoxaparin Sodium, Bivalirudin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin SodiumDrug
Enoxaparin will be subcutaneously administered at a dosage from 4000 to 8000 twice daily according
BivalirudinDrug
Bivalirudin will be intravenously administered to obtain an activated prothrombin time (aPTT) of 1.5 fold of the normal values.
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin sodium | Active comparator | Enoxaparin sodium twice daily, according to the renal function and clinical indication Receives: 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. Receives: Drug: Bivalirudin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent under invasive mechanical ventilation
number of days that patient would require invasive mechanical ventilation
Measured: from randomization till 28 days after randomization
Secondary outcomes (4)
Incidence of vein thrombosis and embolism
Number of patients with diagnosis of deep vein thrombosis and/or pulmonary embolism
Measured: from randomization till 28 days after randomization or ICU discharge
Gas Exchange
Daily evaluation of oxygenation through arterial blood gases
Measured: Every day till 28 days after randomization or ICU discharge
Intensive Care Unit length of stay
Number of days spent in Intensive Care Unit
Measured: Up to 1 year
Intensive Care Unit mortality
Number of patients died during the Intensive Care Unit stay
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start20 Apr 2022
- Primary completion30 Jun 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Longhini, University Magna Graecia
- Investigators
- Federico Longhini, MD, Principal investigator, Magna Graecia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334654
- Sponsor's protocol ID
- Bivalirudin COVID-19
- Status last verified
- Aug 2022
- First submitted
- 13 Apr 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bivalirudin Versus Enoxaparin for Anticoagulation in Critically Ill COVID-19 Patients: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05334654
- Acronym / sponsor ID
- Bivalirudin COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin sodium | Active comparator | Drug: Enoxaparin SodiumEnoxaparin sodium twice daily, according to the renal function and clinical indication |
| Bivalirudin | Experimental | Drug: BivalirudinBivalirudin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- known allergies to one of the two investigated drugs
- presence of hematological diseases
- pregnancy
- recent (10 days) surgery
- presence of active bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin SodiumEnoxaparin will be subcutaneously administered at a dosage from 4000 to 8000 twice daily according | Drug | Enoxaparin sodium |
| BivalirudinBivalirudin will be intravenously administered to obtain an activated prothrombin time (aPTT) of 1.5 fold of the normal values. | Drug | Bivalirudin |
Primary outcome
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
4 secondary outcomes
Incidence of vein thrombosis and embolism
Time frame: from randomization till 28 days after randomization or ICU discharge
Gas Exchange
Time frame: Every day till 28 days after randomization or ICU discharge
Intensive Care Unit length of stay
Time frame: Up to 1 year
Intensive Care Unit mortality
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico Longhini, MD principal investigator
Magna Graecia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enoxaparin Sodium and Bivalirudin in people with Acute Respiratory Failure and SARS CoV 2 Infection, run by University Magna Graecia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent under invasive mechanical ventilation (time frame: from randomization till 28 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.