Inhaled Heparin for Hospitalised Patients With Coronavirus Disease 2019 (COVID-19)

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Australian National University
• Collaborators: John Hunter Hospital; Royal North Shore Hospital; St George Hospital, Australia; St Vincent's Hospital Melbourne; The George Institute
• Treatments: Calcium heparin; Heparin

Criteria

Inclusion Criteria:

• Age 18 years or older

• Currently admitted to hospital

• There is a positive sample for COVID-19 within the past 21 days. The sample can be a nasal or pharyngeal swab, sputum, tracheal aspirate, bronchoalveolar lavage, or another sample from the patient

• 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 109 per L

• Pulmonary bleeding or uncontrolled bleeding

• Pregnant or might be pregnant

• 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

• Refusal of participant consent