Title {1}	Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate-to-severe ARDS - a randomized, placebo-controlled, double-blind trial
Trial registration {2a and 2b}.	Primary Registry and trial identifying number: clinicaltrialsregister.eu ; EudraCT 2017-003855-47 Date of registration in primary registry: 2 February 2018 Secondary identifying numbers: not applicable Sources of monetary or material support: Apeptico Forschung und Entwicklung GmbH Primary sponsor: Apeptico Forschung und Entwicklung GmbH Secondary sponsor(s): not applicable Contact for public queries: Apeptico Forschung und Entwicklung Prof. Dr. Bernhard Fischer Mariahilfer Str. 136, Top 1.15 1150 Vienna, Austria 00436641432919 b.fischer@apeptico.com Contact for scientific queries: Apeptico Forschung und Entwicklung Prof. Dr. Bernhard Fischer Mariahilfer Str. 136, Top 1.15 1150 Vienna, Austria 00436641432919 b.fischer@apeptico.com Public title: Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate-to-severe ARDS - a randomized, placebo-controlled, double-blind trial Scientific title: Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate-to-severe ARDS - a randomized, placebo-controlled, double-blind trial Countries of recruitment: Austria, Germany Health conditions or problems studied: pulmonary permeability edema in patients with moderate-to-severe ARDS Interventions: Bronchial inhalation of ascending doses of solnatide vs. placebo for seven days Key inclusion and exclusion criteria: Ages eligible: ≥ 18 years Sexes eligible: both Accepts healthy volunteers: no Inclusion criteria: diagnosis of moderate to severe ARDS according to the Berlin definition, need for mechanical ventilation, pulmonary edema (EVLWI ≥10 ml/kg PBW), informed consent Exclusion criteria: allergy against solnatide, severe septic shock, extracorporeal membrane oxygenation at time of screening Study type: interventional allocation: randomized intervention model: parallel assignment masking: double blind (patient, caregiver, investigator, outcomes assessor) Date of first enrolment: 23.05.2018 Target sample size: 95 Recruitment status: ongoing Primary outcome: Safety (mortality, AEs, SAEs, laboratory data, ECG) Key secondary outcomes: extravascular lung water index (EVLWI), pulmonary vascular permeability index (PVPI), oxygenation ratio, ventilation parameters
Protocol version {3}	Version 8.0, 2 August 2021
Funding {4}	Apeptico Entwicklung und Forschung GmbH Commercial sponsor
Author details {5a}	BS, MK, PK, PM: Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Wuerzburg, Wuerzburg, Germany RU, KK, KM: Department of Anaesthesia, General Intensive Care and Pain Medicine, Medical University of Vienna, Austria BF: Apeptico Forschung und Entwicklung GmbH, Vienna, Austria BZ, SF: Department of Anesthesiology, University Hospital of Ludwig-Maximilians-University (LMU), Munich, Germany RL: Vascular Biology Center, Division of Pulmonary Medicine, Medical College of Georgia, Augusta University, Augusta, USA
Name and contact information for the trial sponsor {5b}	Apeptico Forschung und Entwicklung GmbH Prof. Dr. Bernhard Fischer Mariahilfer Straße 136 1150 Vienna, Austria
Role of sponsor {5c}	The role of the sponsor was limited to the study design proposal, obtaining ethics and agencies approval, as well trial registration. The sponsor has no role in the management, analysis and interpretation of data, writing of the report, and the decision to submit the report for publication.