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

Informations projet

Solnatide

N° de convention de subvention: 101003595

DOI 10.3030/101003595

Projet clôturé

Date de signature de la CE 30 Mars 2020

Date de début 1 Avril 2020

Date de fin 30 Juin 2022

Financé au titre de

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

Coût total € 1 626 025,00

Contribution de l’UE € 1 626 025,00

Coordonné par

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

Livrables

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

Auteurs: Schmid, Benedikt; Kranke, Peter; Lucas, Rudolf; Maybohm, Patrick; Zwissler, Bernhard; Frank, Susanne
Publié dans: Trials, Numéro 2, 2022, ISSN 1745-6215
Éditeur: BioMed Central
DOI: 10.1186/s13063-022-06182-3

Conformational ensemble of the TNF-derived peptide solnatide in solution

Auteurs: Martin-Malpartida, Pau; Arrastia-Casado, Silvia; Farrera-Sinfreu, Josep; Lucas, Rudolf; Fischer, Hendrik; Fischer, Bernhard; Eaton, Douglas C.; Tzotzos, Susan; Marcias, Maria J.
Publié dans: Computational and Structural Biotechnology Journal, Numéro 1, 2022, ISSN 2001-0370
Éditeur: Elsevier
DOI: 10.1016/j.csbj.2022.04.031

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

Auteurs: Bernhard Fischer; Hendrik Fischer; Markus Zeitlinger; Susan Tzotzos
Publié dans: Critical Care, Vol 24, Iss 1, Pp 1-4 (2020), Numéro 1, 2020, ISSN 1364-8535
Éditeur: 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.

Auteurs: 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
Publié dans: Trials, Numéro 1, 2021, ISSN 1745-6215
Éditeur: BioMed Central
DOI: 10.1186/s13063-021-05588-9