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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.
Schmid, Benedikt; Kredel, Markus; Ullrich, Roman; Krenn, Katharina; Lucas, Rudolf; Markstaller, Klaus; Fischer, Bernhard; Kranke, Peter; Meybohm, Patrick; Zwißler, Bernhard; Frank, Sandra.
  • Schmid B; Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Wuerzburg, Wuerzburg, Germany.
  • Kredel M; Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Wuerzburg, Wuerzburg, Germany.
  • Ullrich R; Department of Anaesthesia, General Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.
  • Krenn K; Department of Anaesthesia, General Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.
  • Lucas R; Vascular Biology Center, Division of Pulmonary Medicine, Medical College of Georgia, Augusta University, Augusta, USA.
  • Markstaller K; Department of Anaesthesia, General Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.
  • Fischer B; Apeptico Forschung und Entwicklung GmbH, Vienna, Austria.
  • Kranke P; Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Wuerzburg, Wuerzburg, Germany. kranke_p@ukw.de.
  • Meybohm P; Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Wuerzburg, Wuerzburg, Germany.
  • Zwißler B; Department of Anesthesiology, University Hospital of Ludwig-Maximilians-University (LMU), Munich, Germany.
  • Frank S; Comprehensive Pulmonary Center Munich (CPC-M), Member of the German Center for Lung Research (DZL), Munich, Germany.
Trials ; 22(1): 643, 2021 Sep 20.
Article in English | MEDLINE | ID: covidwho-1435265
ABSTRACT

BACKGROUND:

Acute respiratory distress syndrome (ARDS) is a complex clinical diagnosis with various possible etiologies. One common feature, however, is pulmonary permeability edema, which leads to an increased alveolar diffusion pathway and, subsequently, impaired oxygenation and decarboxylation. A novel inhaled peptide agent (AP301, solnatide) was shown to markedly reduce pulmonary edema in animal models of ARDS and to be safe to administer to healthy humans in a Phase I clinical trial. Here, we present the protocol for a Phase IIB clinical trial investigating the safety and possible future efficacy endpoints in ARDS patients.

METHODS:

This is a randomized, placebo-controlled, double-blind intervention study. Patients with moderate to severe ARDS in need of mechanical ventilation will be randomized to parallel groups receiving escalating doses of solnatide or placebo, respectively. Before advancing to a higher dose, a data safety monitoring board will investigate the data from previous patients for any indication of patient safety violations. The intervention (application of the investigational drug) takes places twice daily over the course of 7 days, ensued by a follow-up period of another 21 days.

DISCUSSION:

The patients to be included in this trial will be severely sick and in need of mechanical ventilation. The amount of data to be collected upon screening and during the course of the intervention phase is substantial and the potential timeframe for inclusion of any given patient is short. However, when prepared properly, adherence to this protocol will make for the acquisition of reliable data. Particular diligence needs to be exercised with respect to informed consent, because eligible patients will most likely be comatose and/or deeply sedated at the time of inclusion. TRIAL REGISTRATION This trial was prospectively registered with the EU Clinical trials register (clinicaltrialsregister.eu). EudraCT Number 2017-003855-47 .
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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Pulmonary Edema / Respiratory Distress Syndrome / COVID-19 Subject: Pulmonary Edema / Respiratory Distress Syndrome / COVID-19 Type of study: Controlled clinical trial / Diagnostic study / Prognostic study Language: English Journal: Trials Clinical aspect: Prognosis / Therapy Year: 2021

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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Pulmonary Edema / Respiratory Distress Syndrome / COVID-19 Subject: Pulmonary Edema / Respiratory Distress Syndrome / COVID-19 Type of study: Controlled clinical trial / Diagnostic study / Prognostic study Language: English Journal: Trials Clinical aspect: Prognosis / Therapy Year: 2021
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