INHALEd Nebulised Unfractionated HEParin for the Treatment of Hospitalised Patients With COVID-19 (INHALE-HEP) Australia

INHALE-HEP Australia Version 3

Investigator-initiated, multi-centre, randomised, open-label trial of nebulised heparin sodium in addition to standard care compared to standard care alone in hospitalised patients with COVID-19 infection.

2023-08-01

2023-12-01

2024-03-01

Withdrawn

Early phase I

Inclusion Criteria: * Age 18 years or older * Currently admitted to hospital * There is a positive sample for COVID-19 within the past 14 days. The sample can be a nasal or pharyngeal swab, sputum, tracheal aspirate, bronchoalveolar lavage, or another sample from the patient * Requiring oxygenation according to the modified ordinal clinical scale 4-5 Exclusion Criteria: * Intubated and on mechanical ventilation, or requiring immediate intubation as per the treating clinician's assessment * Heparin allergy or heparin-induced thrombocytopaenia * Activated partial thromboplastin time (APTT) \> 120 seconds, not due to anticoagulant therapy and does not correct with administration of fresh frozen plasma * Platelet count \< 20 x 10\^9 per L within 48 hours of randomisation * Pulmonary bleeding or uncontrolled bleeding within 48 hours of randomisation * Known or suspected pregnancy * Acute brain injury that may result in long-term disability * Myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently e.g. Guillain-Barre syndrome * Treatment limitations in place, i.e. not for intubation, not for ICU admission * Death is imminent or inevitable within 24 hours * Clinician objection * Participant consent declined

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2024-02-26