Safety and Efficacy of AON-D21 in Severe Community-Acquired Pneumonia.
NCT ID: NCT05962606
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2024-02-02
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* The safety and tolerability of AON-D21 vs placebo.
* The efficacy of AON-D21vs placebo.
* The pharmacokinetics of AON-D21.
* The pharmacodynamics of AON D21.
* To identify biomarkers for patient stratification and analyses in future trials.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants diagnosed with severe community-acquired pneumonia of bacterial or viral origin requiring admission to an intensive care unit or similar setting, will receive either AON-D21 or placebo intravenous infusions for up to 10 days.
In addition, participants will receive standard of care as per local guidelines.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AON-D21 plus Standard of Care
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.
AON-D21
AON-D21 is a Pegylated L-configured aptamer that binds and thereby neutralizes the complement component C5a from activating both C5a receptors.
Placebo plus Standard of Care
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.
Placebo
Sterile liquid formulation of 5% glucose solution in matched glass vials with a 1.5 mL fill volume.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AON-D21
AON-D21 is a Pegylated L-configured aptamer that binds and thereby neutralizes the complement component C5a from activating both C5a receptors.
Placebo
Sterile liquid formulation of 5% glucose solution in matched glass vials with a 1.5 mL fill volume.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aptarion Biotech AG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Martin Witzenrath, MD
Role: PRINCIPAL_INVESTIGATOR
Critical Care Medicine. Charité Universitätsmedizin Berlin
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham Heersink School of Medicine
Birmingham, Alabama, United States
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Clinique Saint Pierre
Ottignies, , Belgium
Centre Hospitalier Argenteuil
Argenteuil, , France
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, , France
CHU Dupuytren
Limoges, , France
Centre Hospitalier de Melun
Melun, , France
Hotel Dieu - CHU Nantes
Nantes, , France
Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, , France
Nouvel Hôpital Civil
Strasbourg, , France
CHRU de Tours Hôpital Bretonneau
Tours, , France
Hôpital Nord Franche Comté
Trévenans, , France
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Cologne-Merheim Hospital Lung Clinic
Cologne, , Germany
University Hospital Cologne
Cologne, , Germany
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, , Germany
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Doctor Josep Trueta
Girona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitari Mútua Terrassa
Terrassa, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
University Hospital Bristol and Weston NHS
Bristol, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Liverpool University Hospitals NHS Foundation Trust
Liverpool, , United Kingdom
University College London
London, , United Kingdom
University Hospitals Plymouth NHS Trust, Derriford Hospital
Plymouth, , United Kingdom
Royal Berkshire Foundation Trust
Reading, , United Kingdom
Mid Yokshire Teaching NHS Trust
Wakefield, , United Kingdom
York Hospital
York, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Derek Russell, MD
Role: primary
Xavier Wittebole, Prof.
Role: primary
Nicolas De Schryver, Dr.
Role: primary
Gaetan Plantefeve, Dr.
Role: primary
Jean-Claude Lacherade, Dr.
Role: primary
Bruno Francois, Dr.
Role: primary
Mehran Monchi, Dr.
Role: primary
Gauthier Blonz, Dr.
Role: primary
Jean-Damien Ricard, Prof.
Role: primary
Ferhat Meziani, Prof.
Role: primary
Emmanuelle Mercier, Dr.
Role: primary
Julio Badie, Dr.
Role: primary
Martin Witzenrath, Prof.
Role: primary
Christian Karagiannidis, Dr.
Role: primary
Istvan Vadasz, Prof.
Role: primary
Ricard Ferrer, Dr.
Role: primary
Carolina Lorencio, Dr.
Role: primary
Miguel Sanchez-Garcia, Dr.
Role: primary
Paula Ramirez, Dr.
Role: primary
Matt Wise, Prof.
Role: primary
Ingeborg Welters, Prof.
Role: primary
David Brealey, Dr.
Role: primary
Robert Jackson, Dr
Role: primary
Matthew Frise, Dr.
Role: primary
Brendan Sloan, Dr.
Role: primary
Joseph Carter, Dr.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S-D21-C300
Identifier Type: -
Identifier Source: org_study_id