AON-D21 for Community-Acquired Pneumonia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AON-D21 to evaluate its safety and effectiveness for individuals with severe community-acquired pneumonia. Participants will receive either AON-D21 or a placebo (a non-active substance) alongside standard care. The trial aims to understand how AON-D21 functions in the body and to identify markers that could assist in future studies. It is suitable for those admitted to an ICU with pneumonia requiring breathing support, excluding individuals with hospital-acquired pneumonia or other severe conditions. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic immunosuppressive therapy or a complement inhibitor, you may not be eligible to participate.
Is there any evidence suggesting that AON-D21 is likely to be safe for humans?
Previous studies have tested AON-D21 for safety in treating severe community-acquired pneumonia. Research shows that patients generally tolerated AON-D21 well. Some participants experienced health issues, but these were similar to those seen with a placebo. Since this trial is in Phase 2, there is more confidence in its safety than in earlier stages. This suggests AON-D21 is relatively safe but still under study. Always consider consulting a doctor before joining a trial.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatment for community-acquired pneumonia, which often involves antibiotics like amoxicillin or azithromycin, AON-D21 includes a unique sterile liquid formulation combined with mannitol and EDTA. This new treatment is administered intravenously, potentially enhancing the delivery and effectiveness of active ingredients directly to the site of infection. Researchers are particularly excited about AON-D21 because it might offer a more targeted approach, reducing the severity of pneumonia symptoms more efficiently than conventional treatments.
What evidence suggests that AON-D21 might be an effective treatment for community-acquired pneumonia?
Research suggests that AON-D21, which participants in this trial may receive, might help patients with severe pneumonia by reducing lung inflammation. This treatment blocks a molecule called C5a, which can cause excessive inflammation. Early studies have shown that AON-D21 lowers C5a levels in the body. This reduction might help patients with severe community-acquired pneumonia recover faster. Although more research is needed, these findings are promising for improving outcomes in people with this serious lung infection.13456
Who Is on the Research Team?
Martin Witzenrath, MD
Principal Investigator
Critical Care Medicine. Charité Universitätsmedizin Berlin
Are You a Good Fit for This Trial?
This trial is for adults with severe community-acquired pneumonia who are in the ICU or a similar unit. They must have started respiratory support within the last 48 hours and meet certain criteria like high CRP levels and low oxygen ratios. Women of childbearing age must agree to use dual contraception methods.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either AON-D21 or placebo intravenous infusions for up to 10 days, along with standard of care therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including the evaluation of treatment-emergent adverse events and efficacy measures
Extended Follow-up
Participants are monitored for long-term outcomes such as all-cause mortality and organ support-free days
What Are the Treatments Tested in This Trial?
Interventions
- AON-D21
Trial Overview
The study tests AON-D21 against a placebo, both alongside standard treatments, to see which is safer and more effective for severe pneumonia patients in intensive care. It also looks at how AON-D21 behaves in the body and its effects on different biological markers.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Sterile liquid formulation of AON-D21 in 4% mannitol + 0.05% EDTA in glass vials. It will be administered intravenously, for up to 10 days plus Standard of Care therapy for severe community-acquired pneumonia as per local guidelines.
Sterile liquid formulation of 5% glucose solution in matched glass vials with a 1.5 mL fill volume. It will be administered intravenously, for up to 10 days plus Standard of Care therapy for severe community-acquired pneumonia as per local guidelines.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aptarion Biotech AG
Lead Sponsor
Citations
NCT05962606 | Safety and Efficacy of AON-D21 in Severe ...
The goal of this clinical trial is to compare the safety and efficacy of AON-D21 versus placebo, both on top of standard of care, in patients with severe ...
Aon-D21 – Application in Therapy and Current Clinical ...
The hope is that by reducing excessive inflammation in the lungs, AON-D21 could help patients with severe pneumonia recover faster and potentially save lives.
Safety and Efficacy of AON-D21 in Patients with Severe ...
Patients with Severe Community-Acquired Pneumonia will be given either AON-D21 or Placebo as an "add on" therapy in addition to the medicines their doctors ...
AON-D21 – Complement C5a-neutralizing human/mouse ...
Initial pharmacodynamic results confirm inhibition of circulating C5a in treated patients. The final study results are expected in 2026. References: This will ...
5.
ctv.veeva.com
ctv.veeva.com/study/safety-and-efficacy-of-aon-d21-in-severe-community-acquired-pneumoniaSafety and Efficacy of AON-D21 in Severe Community ...
The goal of this clinical trial is to compare the safety and efficacy of AON-D21 versus placebo, both on top of standard of care, ...
6.
clinicaltrials.gov
clinicaltrials.gov/study/NCT05962606?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Aptarion%20Biotech%20AG%22)&viewType=Table&rank=1Safety and Efficacy of AON-D21 in Severe Community- ...
An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...
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