COVID-19: Can Nebulised HepArin Reduce Time to Extubation in SARS-CoV-2 patients requiring mechanical ventilation (CHARTER Study)

Phase 3

• Conditions: COVID-19 Respiratory Failure; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12620000517976
• Lead Sponsor: St Vincents Hospital Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-27
• Study Completion: 2022-08-17
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Age 18 years or older
In ICU or scheduled for transfer to ICU
Endotracheal tube in place
Intubated yesterday or today
PaO2 to FIO2 ratio less than or equal to 300 while intubated
Acute opacities not fully explained by effusions, lobar/lung collapse and nodules, affecting at least one lung quadrant on chest X-ray or CT
The acute opacities on chest X-ray or CT are most likely due to COVID-19
There is a PCR positive sample for SARS-CoV-2 within the past 21 days or there are results pending or further testing is planned

Exclusion Criteria

Enrolled in another clinical trial that is unapproved for co-enrolment
Heparin allergy or heparin-induced thrombocytopaenia
APTT > 120 seconds and this is not due to anticoagulant therapy
Platelet count < 20 x 10^9 per L
Pulmonary bleeding
Uncontrolled bleeding
Pregnant or might be pregnant
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
Acute brain injury that may result in long-term disability
Usually receives home oxygen
Dependent on others for personal care due to physical or cognitive decline
Death is imminent or inevitable within 24 hours
The clinical team would not be able to set up the study nebuliser and ventilator circuit as required including with active humidification
Clinician objection

Study & Design

• Study Type: Interventional
• Study Design: Not specified