Exploration of safety, tolerability and clinical efficacy of Solnatide IMP in patients infected with the 2019 new coronavirus

Project Information

Solnatide

Grant agreement ID: 101003595

DOI 10.3030/101003595

Project closed

EC signature date 30 March 2020

Start date 1 April 2020

End date 30 June 2022

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost € 1 626 025,00

EU contribution € 1 626 025,00

Coordinated by

RTDS - VEREIN ZUR FORDERUNG DER KOMMUNIKATION UND VERMITTLUNG VON FORSCHUNG, TECHNOLOGIE UND INNOVATION (RTDS VEREIN, ENGL. RTDS ASSOCIATION)
Austria

Deliverables

Documents, reports (3)

GMP (Good Manufacturing Practice) certificate

After completion of the manufacture, a GMP Compliance Certificate will be issued.

SOLANTIDE Draft Clinical Study Report of COVID-19 patients

The PI will prepare a draft clinical study report and all data exported in the eSystem to generate a first statistical draft summary

Report on the suitability of solnatide IMP for treatment of COVID-19

Clinical data related to experience of Solnatide in corona patients will be reported and published

Publications

Peer reviewed articles (4)

Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate to severe ARDS in a randomized, placebo-controlled, double-blind trial: preliminary evaluation of safety and feasibility in light of the COVID- 19 pandemic

Author(s): Schmid, Benedikt; Kranke, Peter; Lucas, Rudolf; Maybohm, Patrick; Zwissler, Bernhard; Frank, Susanne
Published in: Trials, Issue 2, 2022, ISSN 1745-6215
Publisher: BioMed Central
DOI: 10.1186/s13063-022-06182-3

Conformational ensemble of the TNF-derived peptide solnatide in solution

Author(s): Martin-Malpartida, Pau; Arrastia-Casado, Silvia; Farrera-Sinfreu, Josep; Lucas, Rudolf; Fischer, Hendrik; Fischer, Bernhard; Eaton, Douglas C.; Tzotzos, Susan; Marcias, Maria J.
Published in: Computational and Structural Biotechnology Journal, Issue 1, 2022, ISSN 2001-0370
Publisher: Elsevier
DOI: 10.1016/j.csbj.2022.04.031

Incidence of ARDS and outcomes in hospitalized patients with COVID-19: a global literature survey.

Author(s): Bernhard Fischer; Hendrik Fischer; Markus Zeitlinger; Susan Tzotzos
Published in: Critical Care, Vol 24, Iss 1, Pp 1-4 (2020), Issue 1, 2020, ISSN 1364-8535
Publisher: Springer
DOI: 10.1186/s13054-020-03240-7

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.

Author(s): Benedikt Schmid; Markus Kredel; Roman Ullrich; Katharina Krenn; Rudolf Lucas; Klaus Markstaller; Bernhard Fischer; Peter Kranke; Patrick Meybohm; Bernhard Zwißler; Sandra Frank; and the Solnatide Collaborators Group
Published in: Trials, Issue 1, 2021, ISSN 1745-6215
Publisher: BioMed Central
DOI: 10.1186/s13063-021-05588-9