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Title: A Phase I/II Clinical Trial to evaluate the efficacy of baricitinib to prevent respiratory insufficiency progression in onco-hematological patients affected with COVID19: a structured summary of a study protocol for a randomised controlled trial
Author: Moreno González, Gabriel
Mussetti, Alberto
Albasanz Puig, Adaia
Salvador, I.
Sureda, A.
Gudiol González, Carlota
Salazar Soler, Ramón
Marin, M.
Garcia, M.
Navarro, V.
de la Haba Vaca, I.
Coma, E.
Sanz-Linares, G.
Dura, X.
Fontanals, S.
Serrano, G.
Cruz, C.
Máñez Mendiluce, Rafael
Keywords: SARS-CoV-2
Anàlisi de medicaments
Assaigs clínics de medicaments
Drugs analysis
Drug testing
Issue Date: 5-Feb-2021
Publisher: BioMed Central
Abstract: Objectives: Baricitinib is supposed to have a double effect on SARS-CoV2 infection. Firstly, it reduces the inflammatory response through the inhibition of the Januse-Kinase signalling transducer and activator of transcription (JAK-STAT) pathway. Moreover, it reduces the receptor mediated viral endocytosis by AP2-associated protein kinase 1 (AAK1) inhibition. We propose the use of baricinitib to prevent the progression of the respiratory insufficiency in SARS-CoV2 pneumonia in onco-haematological patients. In this phase Ib/II study, the primary objective in the safety cohort is to describe the incidence of severe adverse events associated with baricitinib administration. The primary objective of the randomized phase (baricitinib cohort versus standard of care cohort) is to evaluate the number of patients who did not require mechanical oxygen support since start of therapy until day +14 or discharge (whichever it comes first). The secondary objectives of the study (only randomized phase of the study) are represented by the comparison between the two arms of the study in terms of mortality and toxicity at day+30. Moreover, a description of the immunological related changes between the two arms of the study will be reported. Trial design: The trial is a phase I/II study with a safety run-in cohort (phase 1) followed by an open label phase II randomized controlled trial with an experimental arm compared to a standard of care arm.
Note: Reproducció del document publicat a:
It is part of: Trials, 2021, vol. 22, p. 116
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ISSN: 1745-6215
Appears in Collections:Articles publicats en revistes (Ciències Clíniques)
Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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