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10.1016/j.ebiom.2021.103288 http://scihub22266oqcxt.onion/10.1016/j.ebiom.2021.103288 33752127!7979145!33752127     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=33752127&cmd=llinks): Failed to open stream: HTTP request failed! 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Itraconazole for COVID-19: preclinical studies and a proof-of-concept randomized clinical trial |pdf=|usr=}}{{33752127}} gab.com Text Itraconazole for COVID-19: preclinical studies and a proof-of-concept randomized clinical trial JO: EBioMedicine http://www.kidney.de/pget.php?&tw=1&pmid=33752127 #FOAvip BACKGROUND: The antifungal drug itraconazole exerts in vitro activity against SARS-CoV-2 in Vero and human Caco-2 cells. Preclinical and clinical studies are required to investigate if itraconazole is effective for the treatment and/or prevention of COVID-19. METHODS: Due to the initial absence of preclinical models, the effect of itraconazole was explored in a clinical, proof-of-concept, open-label, single-center study, in which hospitalized COVID-19 patients were randomly assigned to standard of care with or without itraconazole. Primary outcome was the cumulative score of the clinical status until day 15 based on the 7-point ordinal scale of the World Health Organization. In parallel, itraconazole was evaluated in a newly established hamster model of acute SARS-CoV-2 infection and transmission, as soon as the model was validated. FINDINGS: In the hamster acute infection model, itraconazole did not reduce viral load in lungs, stools or ileum, despite adequate plasma and lung drug concentrations. In the transmission model, itraconazole failed to prevent viral transmission. The clinical trial was prematurely discontinued after evaluation of the preclinical studies and because an interim analysis showed no signal for a more favorable outcome with itraconazole: mean cumulative score of the clinical status 49 vs 47, ratio of geometric means 1.01 (95% CI 0.85 to 1.19) for itraconazole vs standard of care. INTERPRETATION: Despite in vitro activity, itraconazole was not effective in a preclinical COVID-19 hamster model. This prompted the premature termination of the proof-of-concept clinical study. FUNDING: KU Leuven, Research Foundation - Flanders (FWO), Horizon 2020, Bill and Melinda Gates Foundation. Twit Text FOAVip Itraconazole for COVID-19: preclinical studies and a proof-of-concept randomized clinical trial ????EBioMedicine http://www.kidney.de/pget.php?&tw=1&pmid=33752127 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=33752127 #FOAvip English Wikipedia <ref>{{Cite pmid|33752127}}</ref> Itraconazole for COVID-19: preclinical studies and a proof-of-concept randomized clinical trial #MMPMID33752127 Liesenborghs L; Spriet I; Jochmans D; Belmans A; Gyselinck I; Teuwen LA; Ter Horst S; Dreesen E; Geukens T; Engelen MM; Landeloos E; Geldhof V; Ceunen H; Debaveye B; Vandenberk B; Van der Linden L; Jacobs S; Langendries L; Boudewijns R; Do TND; Chiu W; Wang X; Zhang X; Weynand B; Vanassche T; Devos T; Meyfroidt G; Janssens W; Vos R; Vermeersch P; Wauters J; Verbeke G; De Munter P; Kaptein SJF; Rocha-Pereira J; Delang L; Van Wijngaerden E; Neyts J; Verhamme P EBioMedicine 2021[Apr]; 66 (ä): 103288 PMID33752127show ga BACKGROUND: The antifungal drug itraconazole exerts in vitro activity against SARS-CoV-2 in Vero and human Caco-2 cells. Preclinical and clinical studies are required to investigate if itraconazole is effective for the treatment and/or prevention of COVID-19. METHODS: Due to the initial absence of preclinical models, the effect of itraconazole was explored in a clinical, proof-of-concept, open-label, single-center study, in which hospitalized COVID-19 patients were randomly assigned to standard of care with or without itraconazole. Primary outcome was the cumulative score of the clinical status until day 15 based on the 7-point ordinal scale of the World Health Organization. In parallel, itraconazole was evaluated in a newly established hamster model of acute SARS-CoV-2 infection and transmission, as soon as the model was validated. FINDINGS: In the hamster acute infection model, itraconazole did not reduce viral load in lungs, stools or ileum, despite adequate plasma and lung drug concentrations. In the transmission model, itraconazole failed to prevent viral transmission. The clinical trial was prematurely discontinued after evaluation of the preclinical studies and because an interim analysis showed no signal for a more favorable outcome with itraconazole: mean cumulative score of the clinical status 49 vs 47, ratio of geometric means 1.01 (95% CI 0.85 to 1.19) for itraconazole vs standard of care. INTERPRETATION: Despite in vitro activity, itraconazole was not effective in a preclinical COVID-19 hamster model. This prompted the premature termination of the proof-of-concept clinical study. FUNDING: KU Leuven, Research Foundation - Flanders (FWO), Horizon 2020, Bill and Melinda Gates Foundation. |*COVID-19 Drug Treatment[MESH] |Animals[MESH] |Antiviral Agents/administration & dosage/pharmacokinetics/*pharmacology/therapeutic use[MESH] |COVID-19/etiology/transmission[MESH] |Chlorocebus aethiops[MESH] |Disease Models, Animal[MESH] |Drug Evaluation, Preclinical[MESH] |Female[MESH] |Humans[MESH] |Itraconazole/administration & dosage/pharmacokinetics/*pharmacology/therapeutic use[MESH] |Male[MESH] |Mesocricetus[MESH] |Middle Aged[MESH] |Pneumonia, Viral/drug therapy/pathology/virology[MESH] |Proof of Concept Study[MESH] |SARS-CoV-2/drug effects[MESH] |Treatment Outcome[MESH]Itraconazole for COVID-19: preclinical studies and a proof-of-concept (epmc).pdf DeepDyve Pubget Overpricing