Nebulized Heparin for Severe COVID-19 (CHARTER-MT Trial)

Phase 2 & 3

Recruiting

Research Sponsored by Australian National University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently in an intensive care unit (ICU) or scheduled for transfer to the ICU. ICU is defined as an area designated for inpatient care of the critically ill where therapies including invasive mechanical ventilation can be provided.

Age 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 28

Awards & highlights

CHARTER-MT Trial Summary

This trialexplores if nebulised Heparin can reduce mortality & time to extubation for patients with COVID-19 requiring mechanical ventilation.

Who is the study for?

This trial is for adults over 18 who are intubated in the ICU with severe COVID-19, showing lung opacities likely due to the virus. They must have been intubated recently and not be pregnant, allergic to heparin, or have certain bleeding disorders or other conditions that could interfere with treatment.Check my eligibility

What is being tested?

The CHARTER-MT study tests if nebulised unfractionated heparin can help patients on mechanical ventilation recover faster from severe COVID-19. Patients will receive either heparin or standard care/placebo every six hours for up to ten days while ventilated.See study design

What are the potential side effects?

Potential side effects of nebulised heparin may include bleeding complications, irritation of airways, and possible allergic reactions in those sensitive to heparin.

CHARTER-MT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently in the ICU or will be moved there soon.

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I am 18 years old or older.

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I was put on a breathing machine either today or yesterday.

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I have tested positive for COVID-19 or am waiting for test results.

CHARTER-MT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Alive and Ventilator Free Score

CHARTER-MT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Nebulised heparinExperimental Treatment1 Intervention

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.

Group II: Control groupActive Control1 Intervention

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).

0 / 4Eligibility criteria met