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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04511923
Other study ID # NUIG-2020-003
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date December 23, 2020
Est. completion date January 2022

Study information

Verified date February 2021
Source University College Hospital Galway
Contact John Laffey
Phone +353 91 544074
Email John.laffey@nuigalway.ie
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date January 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Nebulised heparin
Nebulised unfractionated heparin 25000 units administered 6 hourly for 10 days

Locations

Country Name City State
Ireland University Hospital Galway Galway

Sponsors (1)

Lead Sponsor Collaborator
University College Hospital Galway

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary D-dimer profile 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.
Primary Frequenccy of Severe Adverse Outcomes 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 Oxygenation Index Determine the impact of nebulised heparin on oxygenation index Up to day 10
Secondary Indices of Inflammation Effect of nebulised heparin on indices of inflammation (Interleukin (IL)-1ß, 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
Secondary Ratios of Indices of Inflammation Effect of nebulised heparin on the ratios of IL-1ß/IL-10 and IL-6/IL-10 will also be assessed. Up to day 10
Secondary Indices of Coagulation 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
Secondary Quasi-Static Lung Compliance 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
Secondary Time to separation from advanced respiratory support Time to separation from advanced respiratory support, where non survivors are treated as though not separated from advanced respiratory support. Up to day 28
Secondary Number treated with neuromuscular blockers Number treated with neuromuscular blockers instituted after enrolment Up to day 10
Secondary Number treated with Prone positioning Number treated with prone positioning instituted after enrolment Up to day 10
Secondary Number treated with extra-corporeal membrane oxygenation Number treated with extra-corporeal membrane oxygenation instituted after enrolment Up to day 10
Secondary Number requiring Tracheostomy Number tracheotomised Up to day 28
Secondary Time to separation from invasive ventilation among survivors Time to separation from invasive ventilation among survivors Up to day 28
Secondary Discharge to ward 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
Secondary Discharge to ward in survivors Time to discharge from the ICU to day 28, among survivors Up to day 28
Secondary Patient Survival Survival to day 28; Survival to day 60; and Survival to hospital discharge, censored at day 60 Up to day 60
Secondary Number of patients residing at home or in a community setting at day 60 Number residing at home or in a community setting at day 60 Up to day 60
Secondary Number of surviving patients residing at home or in a community Number residing at home or in a community setting at day 60, among survivors Up to day 60
Secondary Ventilatory ratio Effect of nebulised heparin on ventilatory ratio measured every 6 hours Up to day 10
Secondary Number treated with awake prone positioning Number of patients treated with awake prone positioning Up to day 10
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