Nebulised Heparin to Reduce COVID-19 Induced Acute Lung Injury (CHARTER-Irl)

July 23, 2024 updated by: John Laffey, University College Hospital Galway

Can Nebulised HepArin Reduce acuTE Lung Injury in Patients With SARS-CoV-2 Requiring Respiratory Support in Ireland

The investigators present a randomised open label phase Ib/IIa trial of nebulised unfractionated heparin to evaluate the effect of nebulised unfractionated heparin on the procoagulant response in ICU patients with SARS-CoV-2 requiring advanced respiratory support. As this is one of the first studies of nebulised heparin in COVID 19 lung disease the investigators will assess safety as a co-primary outcome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Ireland
      • Galway, Ireland
        • University Hospital Galway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

To be eligible, a patient must satisfy all these inclusion criteria:

  1. Confirmed or suspected COVID-19. Note, if 'suspected', results must be pending or testing intended
  2. Ability to obtain informed consent/assent to participate in study
  3. Age 18 years or older
  4. Requiring high flow nasal oxygen or positive pressure ventilator support or invasive mechanical ventilation for a time period of no greater than 48 hours
  5. D-dimers > 200 ng/ml
  6. PaO2 to FIO2 ratio less than or equal to 300
  7. Acute opacities on chest imaging affecting at least one lung quadrant. Note 'Acute opacities' do not include effusions, lobar/lung collapse or nodules
  8. Currently in a higher level of care area designated for inpatient care of patients where therapies including non-positive pressure ventilatory support can be provided.

Exclusion criteria

To be eligible, a patient must have none of these exclusion criteria:

  1. Enrolled in another clinical trial that is unapproved for co-enrolment
  2. Heparin allergy or heparin-induced thrombocytopaenia
  3. APTT > 100 seconds
  4. Platelet count < 50 x 109 per L
  5. Pulmonary bleeding, which is frank bleeding in the trachea, bronchi or lungs with repeated haemoptysis or requiring repeated suctioning
  6. Uncontrolled bleeding
  7. Pregnant or suspected pregnancy (Urine or serum HCG will be recorded)
  8. Receiving or about to commence ECMO or HFOV
  9. Myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently e.g. Guillain-Barre syndrome
  10. Usually receives home oxygen
  11. Dependent on others for personal care due to physical or cognitive decline (pre-morbid status)
  12. Death is imminent or inevitable within 24 hours
  13. The clinical team would not be able to set up the study nebuliser and ventilator circuit as required including with active humidification
  14. Clinician objection.
  15. The use or anticipated use of nebulised tobramycin during this clinical episode
  16. Any other specific contraindication to anticoagulation including prophylactic anticoagulation not otherwise listed here
  17. Relapse in clinical condition in patient that had fully weaned from advanced respiratory support
  18. Any systemic anticoagulation other than prophylactic anticoagulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard Care
Standard care
Experimental: Heparin
Standard care plus nebulised unfractionated heparin 25000 units every 6 hours for 10 days
Drug: Nebulised heparin
Nebulised unfractionated heparin 25000 units administered 6 hourly for 10 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
D-dimer profile
Time Frame: Up to day 10.
Effect of nebulised heparin on d-dimer profile, assessed via d-dimer AUC and via a mixed effects model, with data collected on days 1, 3, 5 and 10.
Up to day 10.
Frequenccy of Severe Adverse Outcomes
Time Frame: Up to day 60
Safety of nebulised heparin delivered by aerogen solo nebuliser in patients with COVID-19 induced severe respiratory failure, as measured by the incidence of severe adverse events.
Up to day 60

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oxygenation Index
Time Frame: Up to day 10
Determine the impact of nebulised heparin on oxygenation index
Up to day 10
Indices of Inflammation
Time Frame: Up to day 10
Effect of nebulised heparin on indices of inflammation (Interleukin (IL)-1β, IL-6, IL-8, IL-10 and soluble TNF receptor 1 (sTNFR1), C-reactive protein, procalcitonin, Ferritin,) will be assessed (AUC on days 1, 3, 5 and 10)
Up to day 10
Ratios of Indices of Inflammation
Time Frame: Up to day 10
Effect of nebulised heparin on the ratios of IL-1β/IL-10 and IL-6/IL-10 will also be assessed.
Up to day 10
Indices of Coagulation
Time Frame: Up to day 10
Effect of nebulised heparin on other indices of coagulation (Fibrinogen; lactate dehydrogenase) will be assessed (AUC on days 1, 3, 5 and 10).
Up to day 10
Quasi-Static Lung Compliance
Time Frame: Up to day 10
Determine the effect of nebulised heparin on Quasi-Static Lung Compliance (i.e. tidal volume/(Plateau pressure-PEEP) measured on days 1,3,5,10.
Up to day 10
Time to separation from advanced respiratory support
Time Frame: Up to day 28
Time to separation from advanced respiratory support, where non survivors are treated as though not separated from advanced respiratory support.
Up to day 28
Number treated with neuromuscular blockers
Time Frame: Up to day 10
Number treated with neuromuscular blockers instituted after enrolment
Up to day 10
Number treated with Prone positioning
Time Frame: Up to day 10
Number treated with prone positioning instituted after enrolment
Up to day 10
Number treated with extra-corporeal membrane oxygenation
Time Frame: Up to day 10
Number treated with extra-corporeal membrane oxygenation instituted after enrolment
Up to day 10
Number requiring Tracheostomy
Time Frame: Up to day 28
Number tracheotomised
Up to day 28
Time to separation from invasive ventilation among survivors
Time Frame: Up to day 28
Time to separation from invasive ventilation among survivors
Up to day 28
Discharge to ward
Time Frame: Up to day 28
Time to separation from the ICU to day 28, where non-survivors to day 28 are treated as though not separated from invasive care
Up to day 28
Discharge to ward in survivors
Time Frame: Up to day 28
Time to discharge from the ICU to day 28, among survivors
Up to day 28
Patient Survival
Time Frame: Up to day 60
Survival to day 28; Survival to day 60; and Survival to hospital discharge, censored at day 60
Up to day 60
Number of patients residing at home or in a community setting at day 60
Time Frame: Up to day 60
Number residing at home or in a community setting at day 60
Up to day 60
Number of surviving patients residing at home or in a community
Time Frame: Up to day 60
Number residing at home or in a community setting at day 60, among survivors
Up to day 60
Ventilatory ratio
Time Frame: Up to day 10
Effect of nebulised heparin on ventilatory ratio measured every 6 hours
Up to day 10
Number treated with awake prone positioning
Time Frame: Up to day 10
Number of patients treated with awake prone positioning
Up to day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College Hospital Galway

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Laffey, Professor of Anaesthesia and Intensive Care Medicine, National University of Ireland, Galway, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NUIG-2020-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Investigator will consider requests to share anonymised data for the purposes of meta-analysis following discussion with the sponsor.

IPD Sharing Time Frame

Investigator will consider release of the above data once the study report has been completed.

IPD Sharing Access Criteria

To be confirmed, prior to enrollment of the first patient.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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