Publications Other (14) Management of pharmacovigilance during the COVID-19 pandemic crisis by the safety department of an academic sponsor: lessons learnt and challenges from the EU DisCoVeRy clinical trial Author(s): Diallo A and DisCoVeRy Study Group Published in: 2023 Publisher: Pharmacol Res Perspect DOI: 10.1002/prp2.1072 Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group Author(s): EU-Response investigators group; Alpha Diallo; Marius Trøseid; Victoria Charlotte Simensen; Anaïs Boston; Jacques Demotes; Inge Christoffer Olsen; Florence Chung; José Artur Paiva ; Maya Hites ; Florence Ader ; Jose Ramon Arribas ; Andreas Baratt-Due ; Øyvind Melien ; Evelina Tacconelli ; Thèrèse Staub ; Richard Greil ; Sotirios Tsiodras ; Matthias Briel ; Hélène Esperou ; France Mentré ; Published in: Clinical Microbiology and Infection, 2021 Publisher: Elsevier DOI: 10.1016/j.cmi.2021.10.011 Ensuring quality control in a clinical trial during the COVID-19 pandemic: the experience of the Inserm C20-15 DisCoVeRy study Author(s): Fougerou-Leurent C, Delmas C, Saillard J, Dumousseaux M, Ferrane A et Al. Published in: 2023 Publisher: Contemp Clin Trials DOI: 10.1016/j.cct.2023.107267 Effects of remdesivir in patients hospitalised with COVID-19: a systematic review and individual patient data meta-analysis of randomised controlled trials Author(s): Amstutz A, Speich B, Mentré F, Rueegg CS, Belhadi D, Assoumou L, Burdet C, Murthy S, Dodd LE, Wang Y, Tikkinen KAO, Ader F, Hites M et al Published in: 2023 Publisher: Lancet Respir Med DOI: 10.1016/s2213-2600(22)00528-8 Assessing the evidence on remdesivir Author(s): Troseid M, Hites M, Barrat-Due, Ader F, Yazdanpanah Y Published in: The Lancet Infectious Diseases, 2021, Page(s) 1630-31 Publisher: Elsevier DOI: 10.1016/s1473-3099(21)00695-2 Final results of the DisCoVeRy trial of remdesivir for patients admitted to hospital with COVID-19 Author(s): Ader F, Bouscambert-Duchamp M, Hites M, Peiffer-Smadja N, Mentré F, Burdet C ; DisCoVeRy Study Group Published in: 2022 Publisher: Lancet Infect Dis DOI: 10.1016/s1473-3099(22)00295-x Experiences and challenges with the new European Clinical Trials Regulation Author(s): Patrick-Brown TD , Bourner J , Kali S , Trøseid M , Yazdanpanah Y , Olliaro P , Olsen IC Published in: 2023 Publisher: BMC/Springer Nature DOI: 10.21203/rs.3.rs-2514582/v1 Implementation of a Centralised Pharmacovigilance System in Academic Pan-European Clinical Trials: Experience from EU-Response and Conect4Children Consortia Author(s): Terzic V et DisCoVeRy Study Group Published in: 2023 Publisher: Br J Clin Pharmacol DOI: 10.1111/bcp.15669 Immunocompromised patients have been neglected in COVID-19 trials: a call for action Author(s): Marius Trøseid; Maxime Hentzien; Florence Ader; Sandra Wagner Cardoso; Jose R. Arribas; Jean-Michel Molina; Nicolas Mueller; Maya Hites; Fabrice Bonnet; Oriol Manuel; Dominique Costagliola; Beatriz Grinsztejn; Inge Christoffer Olsen; Yazdan Yazdapanah; Alexandra Calmy Published in: European Society of Clinical Microbiology and Infectious Diseases, 2022 Publisher: Elsevier DOI: 10.1016/j.cmi.2022.05.005 Modeling remdesivir antiviral efficacy in COVID-19 hospitalized patients of the randomized, controlled, open-label DisCoVeRy trial Author(s): Guillaume Lingas, Nadège Néant, Alexandre Gaymard, Drifa Belhadi, Gilles Peytavin, Maya Hites, Thérèse Staub , Richard Greil, Jose-Artur Paiva, Julien Poissy, Nathan Peiffer-Smadja, Dominique Costagliola, Yazdan Yazdanpanah, Florent Wallet, Amandine Gagneux-Brunon, France Mentré, Florence Ader Charles Burdet, Jérémie Guedj, Maude Bouscambert-Duchamp and the DisCoVeRy study group Published in: MEDRXIV, 2021 Publisher: medRxiv DOI: 10.1101/2021.10.19.21265209;t Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial Author(s): Trøseid M, Arribas JR, Assoumou L, Holten AR, Poissy J, Terzić V, Mazzaferri F, Baño JR, Eustace J, Hites M, Joannidis M, Paiva JA, Reuter J, Püntmann I, Patrick-Brown TDJH, Westerheim E, Nezvalova-Henriksen K, Beniguel L, Dahl TB, Bouscambert M, Halanova M, Péterfi Z, Tsiodras S, Rezek M, Briel M, Ünal S, Schlegel M, Ader F, Lacombe K, Amdal CD, Rodrigues S, Tonby K, Gaudet A, Heggelund L, Published in: 2023 Publisher: BMC DOI: 10.1186/s13054-022-04205-8 An open-label randomized controlled trial of the effect of lopinavir/ritonavir, lopinavir/ritonavir plus IFN-B--1a and hydroxychloroquine in hospitalized patients with COVID-19 Author(s): Florence Ader 1, Nathan Peiffer-Smadja 2, Julien Poissy 3, Maude Bouscambert-Duchamp 4, Drifa Belhadi 5, Alpha Diallo 6, Christelle Delmas 7, Juliette Saillard 7, Aline Dechanet 8, Noémie Mercier 6, Axelle Dupont 9, Toni Alfaiate 9, François-Xavier Lescure 10, François Raffi 11, François Goehringer 12, Antoine Kimmoun 13, Stéphane Jaureguiberry 14, Jean Reign Published in: Clinical Microbiology and Infection, 2021 Publisher: Elsevier DOI: 10.1016/j.cmi.2021;05.020 Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial. Author(s): Florence Ader, Prof, MD,a,b,* Maude Bouscambert-Duchamp, PharmD,c Maya Hites, Prof, MD,d Nathan Peiffer-Smadja, MD,e,f,g Julien Poissy, Prof, MD,h,i Drifa Belhadi, MSc,e,j Alpha Diallo, MD,k Minh-Patrick Lê, PharmD,l,m Gilles Peytavin, PharmD,e,l Thérèse Staub, Prof, MD,n Richard Greil, Prof, MD,o,p,q Jérémie Guedj, PhD,e Jose-Artur Paiva, Prof, MD,r,s Dominique Costagliola, PhD, Published in: 2021 Publisher: Elsevier DOI: 10.1016/s1473-3099(21)00485-0 Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults Author(s): Florence Ader corresponding author and Discovery French Trial Management Team Published in: 2020 Publisher: BMJ Open DOI: 10.1136/bmjopen-2020-041437 Peer reviewed articles (2) Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results Author(s): WHO Solidarity Trial Consortium; Hongchao Pan 1, Richard Peto 1, Ana-Maria Henao-Restrepo 1, Marie-Pierre Preziosi 1, Vasee Sathiyamoorthy 1, Quarraisha Abdool Karim 1, Marissa M Alejandria 1, César Hernández García 1, Marie-Paule Kieny 1, Reza Malekzadeh 1, Srinivas Murthy 1, K Srinath Reddy 1, Mirta Roses Periago 1, Pierre Abi Hanna 1, Florence Ader 1, Abdullah Published in: The new england journal o f medicine, Issue 00284793, 2021, ISSN 0028-4793 Publisher: Massachusetts Medical Society DOI: 10.1056/nejmoa2023184 Effect of remdesivir on viral dynamics in COVID-19 hospitalized patients: a modelling analysis of the randomized, controlled, open-label DisCoVeRy trial Author(s): Guillaume Lingas; Nadège Néant; Alexandre Gaymard; Drifa Belhadi; Gilles Peytavin; Maya Hites; Thérèse Staub; Richard Greil; Jose-Artur Paiva; Julien Poissy; Nathan Peiffer-Smadja; Dominique Costagliola; Yazdan Yazdanpanah; Florent Wallet; Amandine Gagneux-Brunon; France Mentré; Florence Ader; Charles Burdet; Jérémie Guedj; Maude Bouscambert-Duchamp Published in: Journal of Antimicrobial Chemotherapy, Issue 03057453, 2022, ISSN 0305-7453 Publisher: Oxford University Press DOI: 10.1093/jac/dkac048 Searching for OpenAIRE data... 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