Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability oedema in patients with moderate-to-severe ARDS - a randomised, placebo-controlled, double-blind trial

Phase 1

Active, not recruiting

• Conditions: pulmonary permeability oedema in patients with moderate-to-severe ARDS; MedDRA version: 21.1Level: LLTClassification code 10003083Term: ARDSSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0Level: PTClassification code 10037423Term: Pulmonary oedemaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-003855-47-DE
• Lead Sponsor: Apeptico Forschung und Entwicklung GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-02
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

The study will enrol patients with pulmonary permeability oedema (EVLWI = 10) and moderate to severe ARDS admitted to an Intensive Care Unit (ICU) and under mechanical ventilation*. To be eligible to participate in this study, an individual must meet all the following criteria:
1.Informed consent (for details see Section 10.1.1)
2.Male or female =18 years of age
3.Patient has been admitted to an ICU, is mechanically ventilated (according to the ventilation and weaning protocol as outlined in the study protocol) and stable in this condition for at least 8 hours
4.Moderate and severe ARDS diagnosis as defined by the Berlin Definition:
•Onset of ARDS within 1 week of a known clinical insult or new or worsening respiratory symptoms
•Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules
•Respiratory failure not fully explained by cardiac failure or fluid overload (origin of oedema)
•PaO2/FiO2 = 200 mm Hg with Positive End-Expiratory Pressure (PEEP) =5 cm H2O
5.Verified ARDS diagnosis (moderate or severe according to BERLIN Definition) not older than 48 hours
6.Extravascular lung water index (EVLWI) = 10 mL/PBW, as assessed with a validated bedside measurement (single indicator transpulmonary thermodilution measurement with the PiCCO system)
7.Patient who meets criteria for extensive hemodynamic monitoring as per international intensive-care medicine standards

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of clinically relevant allergies or idiosyncrasies to solnatide
2. Known use of any other investigational or non-registered drug within 30 days prior to study enrollment
3. Severe state of septic shock with a Mean Arterial Pressure (MAP) = 65 mm Hg and serum lactate level > 4 mmol/L (36 mg/dL) despite adequate volume resuscitation
4. An underlying clinical condition that, in the opinion of the Investigator, would make it very unlikely for the patient to be successfully weaned from ventilation due to severe underlying diseases (e.g. severe malnutrition, severe neurological diseases, pulmonary fibrosis or COPD)
5. Extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support. Patients should not be denied this procedure or the procedure should not be delayed to avoid exclusion from the study.
6. Neutrophil count < 0.3 x 10^9/L
7. Cancer treatment (chemotherapy or biological) or therapy with other immunosuppressive agents for organ transplantation within 2 weeks
8. Cachexia (BMI < 18.5 kg/m2)
9. Cardiogenic pulmonary edema diagnosed by echocardiography or pulmonary artery catheter
10. Skin burns involving more than 15% of body surface
11. Subjects who are extremely unlikely to survive more than 48 hours due to the acute conditions of the patient in the opinion of the Investigator
12. Subjects transferred from a hospital not participating in this study who are already planned to be re-transferred during the observation period
13. Subjects who are not expected to survive the next month because of an underlying uncorrectable medical condition or a do not resuscitate order
14. Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified