ACTRN12620000517976.

Study name	A randomised controlled trial of nebulised heparin in critically ill mechanically ventilated patients with COVID‐19 to assess the effect on the duration of mechanical ventilation
Starting date	21 May 2020
Contact information	Barry Dixon St Vincent’s Hospital, Melbourne, Australia +613439618815 | barry.dixon@svha.org.au
Methods	Prospective, multicentre, 2‐armed, parallel‐assignment RCT
Participants	172 participants, ≥ 18 years, female and male Inclusion criteria Confirmed or suspected COVID‐19 infection Age ≥ 18 years Endotracheal tube in place Intubated yesterday or today PaO2 to FIO2 ratio ≤ 300 while intubated Acute opacities on chest imaging affecting at least 1 lung quadrant Exclusion criteria Enrolled in another clinical study that is unapproved for co‐enrolment Heparin allergy or heparin‐induced thrombocytopaenia aPTT > 120 s and this is not due to anticoagulant therapy Platelet count < 20 x 109/L Pulmonary bleeding Uncontrolled bleeding Obvious or suspected pregnancy Receiving or about to commence ECMO or HFOV Myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently e.g. Guillain‐Barre syndrome Usually receives home oxygen Dependent on others for personal care due to physical or cognitive decline Death is imminent or inevitable within 24 h The clinical team would not be able to set up the study nebuliser and ventilator circuit as required including with active humidification Clinician objection
Interventions	Experimental: nebulised (vibrating mesh nebuliser) heparin sodium 25,000 IU in 5 mL 6‐hourly/day 10 while invasively ventilated in addition to standard care. The medication will be prescribed and administration documented in the medical record. Comparator: standard care represents the treatments routinely provided by the medical team managing the patient. Standard care will be at the discretion of the medical team.
Outcomes	Primary Time to separation from invasive ventilation, censored at day 28, with non‐survivors treated as though never separated from the ventilator. This will be assessed from review of the medical records. Secondary Time to separation from invasive ventilation, censored at day 28, among survivors. This will be assessed from review of the medical records. Time to separation from ICU, censored at day 28, with non‐survivors treated as though not separated from the ICU. This will be assessed from review of the medical records. Time to separation from ICU, censored at day 28, among survivors. This will be assessed from review of the medical record. Tracheotomy. This will be assessed from review of the medical records. Readmission to ICU. This will be assessed from review of the medical records. Survival to hospital discharge. This will be assessed from review of the medical records. Survival. This will be assessed from review of the medical records. Place of residence. This will be assessed from review of the medical records and contact with the participant.
Notes	ACTRN12620000517976p | No data provided