European Research and Preparedness Network for Pandemics and Emerging Infectious Diseases

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Pubblicazioni

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

Autori: Diallo A and DisCoVeRy Study Group
Pubblicato in: 2023
Editore: 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

Autori: 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 ;
Pubblicato in: Clinical Microbiology and Infection, 2021
Editore: 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

Autori: Fougerou-Leurent C, Delmas C, Saillard J, Dumousseaux M, Ferrane A et Al.
Pubblicato in: 2023
Editore: 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

Autori: 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
Pubblicato in: 2023
Editore: Lancet Respir Med
DOI: 10.1016/s2213-2600(22)00528-8

Assessing the evidence on remdesivir

Autori: Troseid M, Hites M, Barrat-Due, Ader F, Yazdanpanah Y
Pubblicato in: The Lancet Infectious Diseases, 2021, Pagina/e 1630-31
Editore: 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

Autori: Ader F, Bouscambert-Duchamp M, Hites M, Peiffer-Smadja N, Mentré F, Burdet C ; DisCoVeRy Study Group
Pubblicato in: 2022
Editore: Lancet Infect Dis
DOI: 10.1016/s1473-3099(22)00295-x

Experiences and challenges with the new European Clinical Trials Regulation

Autori: Patrick-Brown TD , Bourner J , Kali S , Trøseid M , Yazdanpanah Y , Olliaro P , Olsen IC
Pubblicato in: 2023
Editore: 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

Autori: Terzic V et DisCoVeRy Study Group
Pubblicato in: 2023
Editore: Br J Clin Pharmacol
DOI: 10.1111/bcp.15669

Immunocompromised patients have been neglected in COVID-19 trials: a call for action

Autori: 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
Pubblicato in: European Society of Clinical Microbiology and Infectious Diseases, 2022
Editore: 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

Autori: 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
Pubblicato in: MEDRXIV, 2021
Editore: 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

Autori: 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,
Pubblicato in: 2023
Editore: 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

Autori: 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
Pubblicato in: Clinical Microbiology and Infection, 2021
Editore: 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.

Autori: 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,
Pubblicato in: 2021
Editore: 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

Autori: Florence Ader corresponding author and Discovery French Trial Management Team
Pubblicato in: 2020
Editore: BMJ Open
DOI: 10.1136/bmjopen-2020-041437

Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results

Autori: 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
Pubblicato in: The new england journal o f medicine, Numero 00284793, 2021, ISSN 0028-4793
Editore: 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

Autori: 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
Pubblicato in: Journal of Antimicrobial Chemotherapy, Numero 03057453, 2022, ISSN 0305-7453
Editore: Oxford University Press
DOI: 10.1093/jac/dkac048

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