Status:
WITHDRAWN
Inhaled Heparin for Hospitalised Patients With Coronavirus Disease 2019 (COVID-19)
Lead Sponsor:
Australian National University
Collaborating Sponsors:
The George Institute
St George Hospital, Australia
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 infec...
Detailed Description
Heparin has been used as a medicine for over 75 years. It is used mostly as an anticoagulant (blood thinner), injected under the skin or infused into a vein to prevent or treat large blood clots. Mos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05184101
Start Date
August 1 2023
End Date
March 1 2024
Last Update
February 26 2024
Active Locations (1)
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1
St George Hospital
Kogarah, New South Wales, Australia, 2217