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Experimental Treatment of Ebola Virus Disease with TKM-130803: A Single-Arm Phase 2 Clinical Trial |
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| Authors: | Jake Dunning Foday Sahr Amanda Rojek Fiona Gannon Gail Carson Baimba Idriss Thomas Massaquoi Regina Gandi Sebatu Joseph Hassan K. Osman Timothy J. G. Brooks Andrew J. H. Simpson Ian Goodfellow Lucy Thorne Armando Arias Laura Merson Lyndsey Castle Rebecca Howell-Jones Raul Pardinaz-Solis Benjamin Hope-Gill Mauricio Ferri Jennifer Grove Mark Kowalski Kasia Stepniewska Trudie Lang John Whitehead Piero Olliaro Mohammed Samai Peter W. Horby for the RAPIDE-TKM trial team |
| Abstract: | BackgroundTKM-130803, a small interfering RNA lipid nanoparticle product, has been developed for the treatment of Ebola virus disease (EVD), but its efficacy and safety in humans has not been evaluated.ConclusionsAdministration of TKM-130803 at a dose of 0.3 mg/kg/d by intravenous infusion to adult patients with severe EVD was not shown to improve survival when compared to historic controls.Trial registrationPan African Clinical Trials Registry PACTR201501000997429 |
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