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Randomized trial to evaluate the safety and efficacy of outpatient treatments in individuals with Covid-19 with risk factors. COVERAGE France Trial: a structured summary

dc.rights.licenseopenen_US
dc.contributor.authorONAISI, Racha
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorDUVIGNAUD, Alexandre
dc.contributor.authorNGUYEN BINH, Antoine
dc.contributor.authorDUPOUY, Julie
dc.contributor.authorCHASTANG, Julie
dc.contributor.authorLE BEL, Josselin
dc.contributor.authorLANDMAN, Roland
dc.contributor.authorNACCACHE, Jean Marc
dc.contributor.authorLEFEVRE, Benjamin
dc.contributor.authorPIROTH, Lionel
dc.contributor.authorBINQUET, C.
dc.contributor.authorMAKINSON, Alain
dc.contributor.authorDARNAUD, Thomas
dc.contributor.authorBEGUE, Cyril
dc.contributor.authorWEISS, Laurence
hal.structure.identifierStatistics In System biology and Translational Medicine [SISTM]
dc.contributor.authorRICHERT, Laura
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorANGLARET, Xavier
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorMALVY, Denis
dc.contributor.authorJOSEPH, Jean Philippe
dc.contributor.authorDRUAIS, Pierre-Louis
dc.contributor.authorDARMON, David
dc.contributor.authorRAL, Cedric
hal.structure.identifierStatistics In System biology and Translational Medicine [SISTM]
dc.contributor.authorLHOMME, Edouard
dc.contributor.authorSAINT-LARY, Olivier
dc.date.accessioned2023-06-28T13:21:39Z
dc.date.available2023-06-28T13:21:39Z
dc.date.issued2021-12
dc.identifier.issn0998-3953en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/183233
dc.description.abstractEnContext. The Covid-19 pandemic is of unprecedented magnitude and has had major social and health consequences. Primary care professionals, mainly general practitioners, ensure the care of most patients with Covid-19. An early-stage treatment administered to patients with risk factors for developing a severe disease could reduce hospitalization and death rates. No treatment is currently validated in this indication. Objectives. To evaluate the safety and efficacy of experimental candidate agents delivered in outpatient settings to reduce the risk of hospitalization or death in at-risk patients with early-stage proven Covid-19 and no indication for hospital admission. Methods. Multicentric, open-label, multi-arm, multi-stage (MAMS) randomized controlled trial with a pilot tolerability and safety phase, and a clinical efficacy phase. Efficacy will be determined by the proportion of participants who have an indication for hospital admission, administration of acute oxygen therapy (because of Covid-19) or who decease between D0 and D14 in the experimental treatment group compared to the control group. Expected results. This trial will assess the tolerance and efficacy of diverse treatments administered at an early stage of Covid-19, in patients with risk factors of developing a severe disease. It will also provide information that can contribute to increase primary care actors' ability to conduct clinical trials at the national level.
dc.language.isoENen_US
dc.subject.enInternal
dc.subject.enGeneral
dc.subject.enOutpatient
dc.subject.enTreatment
dc.subject.enEarly
dc.subject.enCovid-19
dc.subject.enTrial
dc.subject.enControlled
dc.subject.enRandomized
dc.subject.enProtocols
dc.subject.enClinical
dc.subject.enMedicine
dc.title.enRandomized trial to evaluate the safety and efficacy of outpatient treatments in individuals with Covid-19 with risk factors. COVERAGE France Trial: a structured summary
dc.typeArticle de revueen_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
bordeaux.journalExerceren_US
bordeaux.page451-458en_US
bordeaux.volume178en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamIDLICen_US
bordeaux.teamSISTM_BPHen_US
bordeaux.teamGHIGS_BPHen_US
bordeaux.teamPHARES_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.exportfalse
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Exercer&rft.date=2021-12&rft.volume=178&rft.spage=451-458&rft.epage=451-458&rft.eissn=0998-3953&rft.issn=0998-3953&rft.au=ONAISI,%20Racha&DUVIGNAUD,%20Alexandre&NGUYEN%20BINH,%20Antoine&DUPOUY,%20Julie&CHASTANG,%20Julie&rft.genre=article


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