Nebulized Heparin for Severe COVID-19
(CHARTER-MT Trial)
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.12345
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.14678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nebulised heparin or standard care/placebo while mechanically ventilated
Follow-up
Participants are monitored for ventilator-free days and survival
What Are the Treatments Tested in This Trial?
Interventions
- Nebulised unfractionated heparin (UFH)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Australian National University
Lead Sponsor