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Evaluating AON-D21 for severe community-acquired pneumonia

An Exploratory, Multi-Centre, Interventional, Prospective, Randomised, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of AON-D21 in Patients With Severe Community-Acquired Pneumonia.

Phase 2 Interventional Aptarion Biotech AG · NCT05962606

This study is testing a new treatment called AON-D21 to see if it can help people with severe pneumonia in the ICU feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorAptarion Biotech AG Industry-sponsored
Locations28 sites (Brussels and 27 other locations)
Trial IDNCT05962606 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of AON-D21 compared to a placebo in patients with severe community-acquired pneumonia who are admitted to an intensive care unit. The study will enroll 100 participants, who will be randomized to receive either AON-D21 or placebo alongside standard care for up to 10 days. Key objectives include evaluating the drug's safety, pharmacokinetics, and pharmacodynamics, as well as identifying biomarkers for future patient stratification. The trial seeks to provide insights into the potential benefits of AON-D21 in treating this serious condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with severe community-acquired pneumonia requiring intensive care and respiratory support.

Not a fit: Patients with refractory septic shock or those not expected to survive 72 hours may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients suffering from severe community-acquired pneumonia.

How similar studies have performed: While this approach is novel, similar studies have shown promise in evaluating new treatments for severe pneumonia.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Community-acquired pneumonia, confirmed or suspected of bacterial or viral origin.
* Admitted to an ICU (or similar unit).
* Requiring respiratory support by HFO ≥ 30 L/min with FiO2 ≥ 30% or NIV or IMV or ECMO.
* CRP ≥ 50 mg/L.
* PaO2/FiO2 ratio ≤ 150 mmHg.
* Treatment initiation no more than 48 h after initiation of respiratory support (HFO ≥ 30 L/min with FiO2 ≥ 30%, NIV, IMV or ECMO).
* Written informed consent.
* Age ≥ 18 years to ≤ 85 years.
* Body mass index ≥ 17.5 kg/m² and ≤ 40 kg/m².
* For female participants of childbearing potential, agreement to use dual methods of contraception until Day 60.
* For male participants with female partners of childbearing potential, agreement to use barrier method of contraception until Day 60 and to refrain from donating sperm during the study and for 3 months after the last infusion.

Exclusion Criteria:

* Refractory septic shock.
* Not expected to survive 72 hours.
* Hospital-acquired or ventilator-associated pneumonia or known or suspected pneumonia due to aspiration or other physical injury or trauma or tuberculosis.
* Known or suspected hypersensitivity to AON-D21 or any components of the formulation used (e.g., PEG, mannitol or EDTA) or a history of clinically relevant allergy requiring continuous treatment, or of anaphylaxis.
* Known fibrotic lung disease, bronchiectasis or any other known severe chronic respiratory disease.
* Active malignant disease.
* Factors other than a pathogen suspected or confirmed to be causative for the respiratory insufficiency.
* Hepatocellular injury defined by an ALT or AST value ≥ 3 times the ULN. Known acute or chronic liver disease with Child-Pugh C (See Appendix 13.6.2).
* Any medical disease or condition that, in the opinion of the investigator(s), compromises the participant's safety or compromises the interpretation of the results.
* Receiving chronic immunosuppressive therapy in relevant doses.
* Known immunodeficiency disease/condition.
* Nursing and pregnant women (defined as the state after conception until the termination of gestation, screened in all women of child-bearing potential with a chorionic gonadotrophin (hCG) blood test (local laboratory).
* Current or recent participation in an investigational trial.
* Systemic treatment with any complement inhibitor.
* Known complement deficiency.
* Unlikely to remain at the investigational site beyond 96 h.

Where this trial is running

Brussels and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Community-acquired PneumoniaPneumoniaCommunity-acquiredSevereBacterialViral
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.