COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003349-12/IE

National University of Ireland Galway - Prof John Laffey

john.laffey@nuigalway.ie

2020-08-14

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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.

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

2

NUIG

18

100

Ireland

Critical disease at enrollment

8: Critical disease at enrollment

40

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.

nan

Phase 2

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