NCT04511923.

Study name	Can nebulised heparin reduce acute lung injury in patients with SARS‐CoV‐2 requiring respiratory support in Ireland
Starting date	23 December 2020
Contact information	John Laffey University Hospital Galway Galway, Ireland +353 91 544074 | John.laffey@nuigalway.ie
Methods	Open‐label, parallel‐assignment RCT
Participants	40 participants, ≥ 18 years, female and male Inclusion criteria: Confirmed or suspected COVID‐19. Note, if 'suspected', results must be pending or testing intended Ability to obtain informed consent/assent to participate in study Age ≥ 18 years Requiring high‐flow nasal oxygen or positive pressure ventilator support or invasive mechanical ventilation for a time period of no greater than 48 h D‐dimers > 200 ng/mL PaO2 to FIO2 ratio ≤ 300 Acute opacities on chest imaging affecting at least one lung quadrant. Note 'Acute opacities' do not include effusions, lobar/lung collapse or nodules 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 Enrolled in another clinical trial that is unapproved for co‐enrolment Heparin allergy or HIT aPTT > 100 seconds Platelet count < 50 x 109/L Pulmonary bleeding, which is frank bleeding in the trachea, bronchi or lungs with repeated haemoptysis or requiring repeated suctioning Uncontrolled bleeding Pregnant or suspected pregnancy (urine or serum HCG will be recorded) 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 (pre‐morbid status) 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 The use or anticipated use of nebulised tobramycin during this clinical episode Any other specific contraindication to anticoagulation including prophylactic anticoagulation not otherwise listed here Relapse in clinical condition in patient that had fully weaned from advanced respiratory support Any systemic anticoagulation other than prophylactic anticoagulation
Interventions	Experimental: heparin Standard care plus nebulised UFH 25,000 units every 6 h for 10 days Comparator: standard care
Outcomes	Primary D‐dimer profile (time frame: up to day 10) Frequency of SAEs (time frame: up to day 60) Secondary Oxygenation index (time frame: up to day 10) Indices of inflammation (time frame: up to day 10) Ratios of indices of inflammation (time frame: up to day 10) Indices of coagulation (time frame: up to day 10) Quasi‐static lung compliance (time frame: up to day 10) Time to separation from advanced respiratory support (time frame: up to day 28) Number treated with neuromuscular blockers (time frame: up to day 10) Number treated with prone positioning (time frame: up to day 10) Number treated with ECMO (time frame: up to day 10) Number requiring tracheostomy (time frame: up to day 28) Time to separation from invasive ventilation among survivors (time frame: up to day 28) Discharge to ward (time frame: up to day 28) Discharge to ward in survivors (time frame: up to day 28) Patient survival (time frame: up to day 60) Number of participants residing at home or in a community setting at day 60 (time frame: up to day 60) Number of surviving participants residing at home or in a community (time frame: up to day 60 ) Ventilatory ratio (time frame: up to day 10) Number treated with awake prone positioning (time frame: up to day 10)
Notes	NCT04511923 | No data provided