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Inhaled ciclesonide for outpatient treatment of COVID-19 in adults at risk of adverse outcomes: a randomised controlled trial (COVERAGE).

dc.rights.licenseopenen_US
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorDUVIGNAUD, Alexandre
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorLHOMME, Edouard
dc.contributor.authorONAISI, Racha
dc.contributor.authorSITTA, Rémi
dc.contributor.authorGELLEY, Ambre
dc.contributor.authorCHASTANG, Julie
dc.contributor.authorPIROTH, Lionel
dc.contributor.authorBINQUET, Christine
dc.contributor.authorDUPOUY, Julie
dc.contributor.authorMAKINSON, Alain
dc.contributor.authorLEFÈVRE, Benjamin
dc.contributor.authorNACCACHE, Jean-Marc
dc.contributor.authorROUSSILLON, Caroline
dc.contributor.authorLANDMAN, Roland
dc.contributor.authorWALLET, Cedrick
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorKARCHER, Sophie
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorJOURNOT, Valerie
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorNGUYEN, Duc
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorPISTONE, Thierry
dc.contributor.authorBOUCHET, Stephane
hal.structure.identifierMicrobiologie Fondamentale et Pathogénicité [MFP]
dc.contributor.authorLAFON, Marie-Edith
dc.contributor.authorMOLIMARD, Mathieu
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorTHIEBAUT, Rodolphe
dc.contributor.authorDE LAMBALLERIE, Xavier
dc.contributor.authorJOSEPH, Jean-Philippe
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorRICHERT, Laura
dc.contributor.authorSAINT-LARY, Olivier
hal.structure.identifierBiologie des maladies cardiovasculaires = Biology of Cardiovascular Diseases
dc.contributor.authorDJABAROUTI, Sarah
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorWITTKOP, Linda
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorANGLARET, Xavier
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorMALVY, Denis
dc.date.accessioned2023-01-10T08:59:38Z
dc.date.available2023-01-10T08:59:38Z
dc.date.issued2022-07-01
dc.identifier.issn1469-0691en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/171638
dc.description.abstractEnTo assess the efficacy of inhaled ciclesonide in reducing the risk of adverse outcomes in COVID-19 outpatients at risk of developing severe illness. COVERAGE is an open-label, randomized controlled trial. Outpatients with documented COVID-19, risk factors for aggravation, symptoms for ≤7 days, and absence of criteria for hospitalization are randomly allocated to either a control arm or one of several experimental arms, including inhaled ciclesonide. The primary efficacy endpoint is COVID-19 worsening (hospitalization, oxygen therapy at home, or death) by Day 14. Other endpoints are adverse events, maximal follow-up score on the WHO Ordinal Scale for Clinical Improvement, sustained alleviation of symptoms, cure, and RT-PCR and blood parameter evolution at Day 7. The trial's Safety Monitoring Board reviewed the first interim analysis of the ciclesonide arm and recommended halting it for futility. The results of this analysis are reported here. The analysis involved 217 participants (control 107, ciclesonide 110), including 111 women and 106 men. Their median age was 63 years (interquartile range 59-68), and 157 of 217 (72.4%) had at least one comorbidity. The median time since first symptom was 4 days (interquartile range 3-5). During the 28-day follow-up, 2 participants died (control 2/107 [1.9%], ciclesonide 0), 4 received oxygen therapy at home and were not hospitalized (control 2/107 [1.9%], ciclesonide 2/110 [1.8%]), and 24 were hospitalized (control 10/107 [9.3%], ciclesonide 14/110 [12.7%]). In intent-to-treat analysis of observed data, 26 participants reached the composite primary endpoint by Day 14, including 12 of 106 (11.3%, 95% CI: 6.0%-18.9%) in the control arm and 14 of 106 (13.2%; 95% CI: 7.4-21.2%) in the ciclesonide arm. Secondary outcomes were similar for both arms. Our findings are consistent with the European Medicines Agency's COVID-19 task force statement that there is currently insufficient evidence that inhaled corticosteroids are beneficial for patients with COVID-19.
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial-NoDerivatives 3.0 International (CC BY-NC-ND 3.0)
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/3.0/
dc.subject.enAged
dc.subject.enFemale
dc.subject.enHumans
dc.subject.enMale
dc.subject.enMiddle Aged
dc.subject.enOutpatients
dc.subject.enOxygen
dc.subject.enPregnenediones
dc.subject.enSARS-CoV-2
dc.subject.enTreatment Outcome
dc.subject.enCOVID-19 Drug Treatment
dc.title.enInhaled ciclesonide for outpatient treatment of COVID-19 in adults at risk of adverse outcomes: a randomised controlled trial (COVERAGE).
dc.title.alternativeClin Microbiol Infecten_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/j.cmi.2022.02.031en_US
dc.subject.halSciences du Vivant [q-bio]/Microbiologie et Parasitologie/Parasitologieen_US
dc.identifier.pubmed35304280en_US
bordeaux.journalClinical Microbiology and Infectionen_US
bordeaux.page1010-1016en_US
bordeaux.volume28en_US
bordeaux.hal.laboratoriesBiologie des maladies cardiovasculaires (BMC) - UMR 1034en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219
bordeaux.issue7en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.institutionCNRS
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.import.sourcepubmed
hal.exportfalse
workflow.import.sourcepubmed
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Clinical%20Microbiology%20and%20Infection&rft.date=2022-07-01&rft.volume=28&rft.issue=7&rft.spage=1010-1016&rft.epage=1010-1016&rft.eissn=1469-0691&rft.issn=1469-0691&rft.au=DUVIGNAUD,%20Alexandre&LHOMME,%20Edouard&ONAISI,%20Racha&SITTA,%20R%C3%A9mi&GELLEY,%20Ambre&rft.genre=article


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