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New drug shows promise for severe pneumonia patients in ICU

NCT ID NCT05962606

Disease control Sponsor: Aptarion Biotech AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called AON-D21 in 150 ICU patients with severe community-acquired pneumonia. The goal was to see if adding AON-D21 to standard care is safe and helps patients recover faster compared to a placebo. The trial focused on how quickly patients could stop needing breathing support and monitored side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

150 people

The number who actually took part.

Started

Feb 2024

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Community-Acquired Pneumonia follicular lymphoma pneumonia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Community-acquired pneumonia

Contacts and locations

Locations

  • Assistance Publique-Hopitaux de Paris (AP-HP)

    Paris, France

  • CHRU de Tours Hôpital Bretonneau

    Tours, France

  • CHU Dupuytren

    Limoges, France

  • Centre Hospitalier Argenteuil

    Argenteuil, France

  • Centre Hospitalier Départemental Vendée

    La Roche-sur-Yon, France

  • Centre Hospitalier de Melun

    Melun, France

  • Charité - Universitätsmedizin Berlin

    Berlin, Germany

  • Clinique Saint Pierre

    Ottignies, Belgium

  • Cliniques Universitaires Saint-Luc

    Brussels, Belgium

  • Cologne-Merheim Hospital Lung Clinic

    Cologne, Germany

  • Hospital Clinico San Carlos

    Madrid, Spain

  • Hospital Doctor Josep Trueta

    Girona, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, Spain

  • Hotel Dieu - CHU Nantes

    Nantes, France

  • Hôpital Nord Franche Comté

    Trévenans, France

  • Liverpool University Hospitals NHS Foundation Trust

    Liverpool, United Kingdom

  • Mid Yokshire Teaching NHS Trust

    Wakefield, United Kingdom

  • Nouvel Hôpital Civil

    Strasbourg, France

  • Royal Berkshire Foundation Trust

    Reading, United Kingdom

  • Universitaetsklinikum Giessen und Marburg GmbH

    Giessen, Germany

  • University College London

    London, United Kingdom

  • University Hospital Bristol and Weston NHS

    Bristol, United Kingdom

  • University Hospital of Wales

    Cardiff, United Kingdom

  • University Hospitals Plymouth NHS Trust, Derriford Hospital

    Plymouth, United Kingdom

  • University of Alabama at Birmingham Heersink School of Medicine

    Birmingham, Alabama, 35233, United States

  • York Hospital

    York, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.