Nebulised Heparin in Patients With Severe COVID-19 (CHARTER-MT)
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|ClinicalTrials.gov Identifier: NCT04545541|
Recruitment Status : Recruiting
First Posted : September 11, 2020
Last Update Posted : January 19, 2021
The Can nebulised HepArin Reduce morTality and time to Extubation in Patients with COVID-19 Requiring mechanical ventilation Meta-Trial (CHARTER-MT) is a prospective collaborative individual patient data analysis of randomised controlled trials and early phase studies. Individual studies are being conducted in multiple countries, including Australia, Ireland, the USA, and the UK.
Mechanically ventilated patients with confirmed or strongly suspected SARS-CoV-2 infection, hypoxaemia and an acute pulmonary opacity in at least one lung quadrant on chest X-ray, will be randomised to nebulised heparin 25,000 Units every 6 hours or standard care (open label studies) or placebo (blinded placebo controlled studies) for up to 10 days while mechanically ventilated. All trials will collect a minimum core dataset. The primary outcome for the meta-trial is ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation. Individual studies may have additional outcomes.
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Respiratory Failure||Drug: Nebulised unfractionated heparin (UFH)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Can Nebulised HepArin Reduce morTality and Time to Extubation in Patients With COVID-19 Requiring Mechanical Ventilation Meta-Trial (CHARTER-MT): Protocol for an Investigator-initiated International Meta-trial of Randomised Studies|
|Actual Study Start Date :||November 1, 2020|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||June 2022|
Experimental: Nebulised heparin
Participants assigned to "nebulised UFH" will receive nebulised UFH in addition to the standard care required as determined by the treating team. Nebulised UFH (25,000 Units in 5 mL) will be administered 6-hourly via an Aerogen Solo vibrating mesh nebuliser while patients receive invasive mechanical ventilation in ICU and for a maximum of 10 days.
Drug: Nebulised unfractionated heparin (UFH)
Nebulised UFH (25,000 Units in 5 mL) will be administered 6-hourly via an Aerogen Solo vibrating mesh nebuliser while patients receive invasive mechanical ventilation in ICU and for a maximum of 10 days.
No Intervention: Control group
Participants assigned to 'standard care' will receive the standard care required as determined by the treating team and will not be treated with nebulised heparin (Australia, Ireland).
Participants assigned to "placebo" will receive Nebulised 0.9% Sodium Chloride (5 mL) administered 6-hourly via an Aerogen Solo vibrating mesh nebuliser while patients receive invasive mechanical ventilation in ICU and for a maximum of 10 days (USA).
- Alive and Ventilator Free Score [ Time Frame: Day 28 ]Validated hierarchical composite endpoint, based on mortality and ventilator free days, which is less prone to favour a treatment with discordant effects on survival and days free of ventilation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545541
|Contact: Frank MP van Haren, MD, PhDemail@example.com|
|United States, Maryland|
|Frederick Health Hospital||Recruiting|
|Frederick, Maryland, United States, 21701|
|Contact: Thomas Smoot, PharmD BCPS 240-566-3250 firstname.lastname@example.org|
|Study Chair:||Frank MP van Haren, MD, PhD||Australian National University|