Nebulized Heparin for Severe COVID-19

(CHARTER-MT Trial)

Overseen By Frank MP van Haren, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Australian National University

Disqualifiers: Heparin allergy, Pregnancy, ECMO, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if nebulized heparin can help people with severe COVID-19 get off ventilators faster and improve survival. Participants will receive either nebulized heparin or standard treatment while on a ventilator. The trial focuses on ICU patients who have been recently intubated and have confirmed or likely lung issues due to COVID-19.

As a Phase 2/3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval. Participants have the opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that nebulised heparin is likely to be safe for humans?

Research shows that nebulized unfractionated heparin (UFH) is generally safe for patients. Studies have found no safety issues, including no bleeding in the lungs or elsewhere in the body. This reassures those considering participation in a trial with this treatment. Earlier research on inhaled UFH for lung injuries also supports its safety. While some studies continue, these findings strongly suggest it is well-tolerated in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COVID-19?

Nebulized unfractionated heparin is unique because it uses a different delivery method than most standard COVID-19 treatments. While typical treatments might involve oral or intravenous administration, this approach delivers heparin directly to the lungs through a nebulizer. This method targets the respiratory system more directly, potentially reducing inflammation and improving lung function in severely affected patients. Researchers are excited about this treatment because it could provide faster relief and improve outcomes for those requiring mechanical ventilation, offering a novel way to support critically ill patients.

What evidence suggests that nebulised heparin might be an effective treatment for severe COVID-19?

This trial will compare nebulized unfractionated heparin (UFH) with standard care for severe COVID-19. Studies have shown that nebulized UFH can benefit people with severe COVID-19. Research suggests it might improve oxygen levels and reduce inflammation, major issues for COVID-19 patients. It has also shortened hospital stays and possibly lowered death rates. In studies on conditions like acute lung injury, nebulized UFH reduced lung damage and improved breathing. By lessening the virus's harmful effects, this treatment could help patients come off ventilators more quickly. ^{1 4 6 7 8}

Who Is on the Research Team?

Frank MP van Haren, MD, PhD

Principal Investigator

Australian National University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

You have a breathing tube in your throat.

You have unexplained cloudy areas in your lungs that are affecting a large part of your lung.

Exclusion Criteria

I have a brain injury that could cause long-term disability.

I am currently on or about to start ECMO or HFOV treatment.

My clinical team cannot set up the required nebulizer and ventilator with humidification for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive nebulised heparin or standard care/placebo while mechanically ventilated

Up to 10 days

Continuous monitoring in ICU

Follow-up

Participants are monitored for ventilator-free days and survival

28 days

What Are the Treatments Tested in This Trial?

Interventions

• Nebulised unfractionated heparin (UFH)

Trial Overview

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.

How Is the Trial Designed?

Group I: Nebulised heparin Experimental Treatment 1 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 group Active Control 1 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).

Who Is Running the Clinical Trial?

Australian National University

Lead Sponsor

Trials

19

Recruited

10,000+

Citations

1.

thelancet.com

thelancet.com/journals/lanepe/article/PIIS2589-5370(25)00271-8/fulltext

Efficacy of inhaled nebulised unfractionated heparin to ...

Inhaled nebulised unfractionated heparin (UFH) has been shown to improve outcomes and has been shown to be safe in experimental and clinical studies of ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10452767/

Role of Nebulized Heparin in Clinical Outcome of COVID ...

Nebulized heparin may be useful in the management of COVID-19. Oxygen saturation was greater, inflammatory indicators were lower, and hospital stays were ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S109455392300024X

Inhaled nebulised unfractionated heparin (UFH) for the ...

This pilot study investigated whether nebulised UFH was safe and had any impact on mortality, length of hospitalisation and clinical progression.

4.

ccforum.biomedcentral.com

ccforum.biomedcentral.com/articles/10.1186/s13054-020-03148-2

Nebulised heparin as a treatment for COVID-19 - Critical Care

Trials in patients with acute lung injury and related conditions found inhaled UFH reduced pulmonary dead space, coagulation activation, ...

5.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/0310057X251322783

A randomised, open-label trial of nebulised unfractionated ...

Nebulised unfractionated heparin (UFH) might reduce time to ventilator separation in patients with COVID-19 by reducing virus infectivity, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10064078/

Inhaled nebulised unfractionated heparin (UFH) for the ...

Inhaled nebulised unfractionated heparin (UFH) for the treatment of hospitalised patients with COVID-19: A randomised controlled pilot study · 5. Outcomes · 6.

7.

cidrap.umn.edu

cidrap.umn.edu/covid-19/inhaled-heparin-slashes-ventilation-death-covid-patients-analysis-suggests

Inhaled heparin slashes ventilation, death in COVID ...

"Previous preclinical and clinical studies of inhaled nebulised UFH in lung injury, have shown a positive effect on pulmonary coagulation, ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04530578

Nebulized Heparin in Severe Acute Respiratory Syndrome ...

Efficacy and Safety Study to Evaluate the Use of Nebulized Heparin in Patients With Severe Acute Respiratory Syndrome Covid-19 (SARS-CoV-2). Conditions.