This trial will be carried out in invasively ventilated ICU patients with suspected or confirmed COVID-19 infection
Conditions
Interventions
Trade Name: Heparin Sodium
Product Name: Heparin Sodium
Product Code: PA0281/229/005
Pharmaceutical Form: Solution for injection
INN or Proposed INN: HEPARIN SODIUM
CAS Number: 9041-08-1
Other descri
Sponsors
NUIG
Eligibility
Sex/Gender
All
Inclusion criteria
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 in the ICU / HDU 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
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 weaned from advanced respiratory support 18. Receiving any direct / novel oral anticoagulant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. Safety of nebulised heparin delivered by Aerogun vibrating-mesh nebuliser in patients with COVID-19 induced severe respiratory failure, as measured by the incidence of severe adverse events. ;Secondary Objective: -Determine the impact nebulised heparin (NH)on indices of oxygenation measured 6 hourly -Determine the effect of NH on ventilatory ratio measured every 6 hours. -Determine the effect of NH on pulmonary compliance measured on days 1,3,5 and 10. -Effect of NH on other inflammatory and soluble TNF receptor 1 and coagulation indices will be assessed. -In this study, ‘day 0’ describes the period from randomisation to midnight on the day of enrolment, ‘day 1’ the first calendar day after the day of enrolment, ‘day 2’ the second calendar day after the day of enrolment, and so forth. -Number tracheotomised 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 intensive care -Survival to day 28; Survival to day 60; to hospital discharge, censored at day 60- ;Primary end point(s): Nebulised heparin is administered 6-hourly from enrolment to day 10 post enrolment, provided the patient is receiving invasive mechanical ventilation. Data collection will be completed at day 60. ;Timepoint(s) of evaluation of this end point: Nebulised heparin is administered 6-hourly from enrolment to day 10 post enrolment, provided the patient is receiving invasive mechanical ventilation. Data collection will be completed at day 60. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: Data collection will be completed at day 60. | — |
Countries
Ireland
Contacts
Public ContactProf John Laffey
National University of Ireland Galway
Outcome results
None listed