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Safety and Efficacy of AON-D21 in Severe Community-Acquired Pneumonia.

Recruiting
18 - 85 years of age
Both
Phase 2

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Overview

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 community acquired pneumonia admitted to ICU (or similar unit). The main questions to answer are:

  • 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.

Description

This clinical trial will enroll 100 participants, randomized 2:1 (AON-D21:placebo).

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.

Eligibility

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 ≤ 300 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.

Study details

Community-acquired Pneumonia

NCT05962606

Aptarion Biotech AG

17 June 2024

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