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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.
Mercier N, Belhadi D, DeChanet A, Delmas C, Saillard J, Dumousseaux M, Le Mestre S, Fougerou-Leurent C, Ferrane A, Burdet C, Espérou H, Ader F, Hites M, Peiffer-Smadja N, Poissy J, Andrejak C, Paiva JA, Tacconelli E, Staub T, Greil R, Costagliola D, Mentre F, Yazdanpanah Y, Diallo A; DisCoVeRy Safety Working group. Mercier N, et al. Among authors: tacconelli e. Pharmacol Res Perspect. 2023 Jun;11(3):e01072. doi: 10.1002/prp2.1072. Pharmacol Res Perspect. 2023. PMID: 37269068 Free PMC article. Review.
Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results.
WHO Solidarity Trial Consortium; Pan H, Peto R, Henao-Restrepo AM, Preziosi MP, Sathiyamoorthy V, Abdool Karim Q, Alejandria MM, Hernández García C, Kieny MP, Malekzadeh R, Murthy S, Reddy KS, Roses Periago M, Abi Hanna P, Ader F, Al-Bader AM, Alhasawi A, Allum E, Alotaibi A, Alvarez-Moreno CA, Appadoo S, Asiri A, Aukrust P, Barratt-Due A, Bellani S, Branca M, Cappel-Porter HBC, Cerrato N, Chow TS, Como N, Eustace J, García PJ, Godbole S, Gotuzzo E, Griskevicius L, Hamra R, Hassan M, Hassany M, Hutton D, Irmansyah I, Jancoriene L, Kirwan J, Kumar S, Lennon P, Lopardo G, Lydon P, Magrini N, Maguire T, Manevska S, Manuel O, McGinty S, Medina MT, Mesa Rubio ML, Miranda-Montoya MC, Nel J, Nunes EP, Perola M, Portolés A, Rasmin MR, Raza A, Rees H, Reges PPS, Rogers CA, Salami K, Salvadori MI, Sinani N, Sterne JAC, Stevanovikj M, Tacconelli E, Tikkinen KAO, Trelle S, Zaid H, Røttingen JA, Swaminathan S. WHO Solidarity Trial Consortium, et al. Among authors: tacconelli e. N Engl J Med. 2021 Feb 11;384(6):497-511. doi: 10.1056/NEJMoa2023184. Epub 2020 Dec 2. N Engl J Med. 2021. PMID: 33264556 Free PMC article. Clinical Trial.
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.
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, Mootien J, Johannessen A, Møller JH, Pollan BD, Tveita AA, Kildal AB, Richard JC, Dalgard O, Simensen VC, Baldé A, de Gastines L, Del Álamo M, Aydin B, Lund-Johansen F, Trabaud MA, Diallo A, Halvorsen B, Røttingen JA, Tacconelli E, Yazdanpanah Y, Olsen IC, Costagliola D; EU SolidAct study group. Trøseid M, et al. Among authors: tacconelli e. Crit Care. 2023 Jan 10;27(1):9. doi: 10.1186/s13054-022-04205-8. Crit Care. 2023. PMID: 36627655 Free PMC article. Clinical Trial.
Rare predicted loss-of-function variants of type I IFN immunity genes are associated with life-threatening COVID-19.
Matuozzo D, Talouarn E, Marchal A, Zhang P, Manry J, Seeleuthner Y, Zhang Y, Bolze A, Chaldebas M, Milisavljevic B, Gervais A, Bastard P, Asano T, Bizien L, Barzaghi F, Abolhassani H, Abou Tayoun A, Aiuti A, Alavi Darazam I, Allende LM, Alonso-Arias R, Arias AA, Aytekin G, Bergman P, Bondesan S, Bryceson YT, Bustos IG, Cabrera-Marante O, Carcel S, Carrera P, Casari G, Chaïbi K, Colobran R, Condino-Neto A, Covill LE, Delmonte OM, El Zein L, Flores C, Gregersen PK, Gut M, Haerynck F, Halwani R, Hancerli S, Hammarström L, Hatipoğlu N, Karbuz A, Keles S, Kyheng C, Leon-Lopez R, Franco JL, Mansouri D, Martinez-Picado J, Metin Akcan O, Migeotte I, Morange PE, Morelle G, Martin-Nalda A, Novelli G, Novelli A, Ozcelik T, Palabiyik F, Pan-Hammarström Q, de Diego RP, Planas-Serra L, Pleguezuelo DE, Prando C, Pujol A, Reyes LF, Rivière JG, Rodriguez-Gallego C, Rojas J, Rovere-Querini P, Schlüter A, Shahrooei M, Sobh A, Soler-Palacin P, Tandjaoui-Lambiotte Y, Tipu I, Tresoldi C, Troya J, van de Beek D, Zatz M, Zawadzki P, Al-Muhsen SZ, Alosaimi MF, Alsohime FM, Baris-Feldman H, Butte MJ, Constantinescu SN, Cooper MA, Dalgard CL, Fellay J, Heath JR, Lau YL, Lifton RP, Maniatis T, Mogensen TH, v… See abstract for full author list ➔ Matuozzo D, et al. Genome Med. 2023 Apr 5;15(1):22. doi: 10.1186/s13073-023-01173-8. Genome Med. 2023. PMID: 37020259 Free PMC article.
Clinical phenotypes and quality of life to define post-COVID-19 syndrome: a cluster analysis of the multinational, prospective ORCHESTRA cohort.
Gentilotti E, Górska A, Tami A, Gusinow R, Mirandola M, Rodríguez Baño J, Palacios Baena ZR, Rossi E, Hasenauer J, Lopes-Rafegas I, Righi E, Caroccia N, Cataudella S, Pasquini Z, Osmo T, Del Piccolo L, Savoldi A, Kumar-Singh S, Mazzaferri F, Caponcello MG, de Boer G, Hara GL; ORCHESTRA Study Group; De Nardo P, Malhotra S, Canziani LM, Ghosn J, Florence AM, Lafhej N, van der Gun BTF, Giannella M, Laouénan C, Tacconelli E. Gentilotti E, et al. Among authors: tacconelli e. EClinicalMedicine. 2023 Jul 21;62:102107. doi: 10.1016/j.eclinm.2023.102107. eCollection 2023 Aug. EClinicalMedicine. 2023. PMID: 37654668 Free PMC article.
How European Research Projects Can Support Vaccination Strategies: The Case of the ORCHESTRA Project for SARS-CoV-2.
Azzini AM, Canziani LM, Davis RJ, Mirandola M, Hoelscher M, Meyer L, Laouénan C, Giannella M, Rodríguez-Baño J, Boffetta P, Mates D, Malhotra-Kumar S, Scipione G, Stellmach C, Rinaldi E, Hasenauer J, Tacconelli E. Azzini AM, et al. Among authors: tacconelli e. Vaccines (Basel). 2023 Aug 14;11(8):1361. doi: 10.3390/vaccines11081361. Vaccines (Basel). 2023. PMID: 37631929 Free PMC article.
Host immunological responses facilitate development of SARS-CoV-2 mutations in patients receiving monoclonal antibody treatments.
Gupta A, Konnova A, Smet M, Berkell M, Savoldi A, Morra M, Van Averbeke V, De Winter FH, Peserico D, Danese E, Hotterbeekx A, Righi E; mAb ORCHESTRA working group; De Nardo P, Tacconelli E, Malhotra-Kumar S, Kumar-Singh S. Gupta A, et al. Among authors: tacconelli e. J Clin Invest. 2023 Mar 15;133(6):e166032. doi: 10.1172/JCI166032. J Clin Invest. 2023. PMID: 36727404 Free PMC article.
Exploring the Use of Monoclonal Antibodies and Antiviral Therapies for Early Treatment of COVID-19 Outpatients in a Real-World Setting: A Nationwide Study from England and Italy.
Ciccimarra F, Luxi N, Bellitto C, L' Abbate L, De Nardo P, Savoldi A, Yeomans A, Molokhia M, Tacconelli E, Trifirò G. Ciccimarra F, et al. Among authors: tacconelli e. BioDrugs. 2023 Sep;37(5):675-684. doi: 10.1007/s40259-023-00601-w. Epub 2023 May 6. BioDrugs. 2023. PMID: 37148526 Free PMC article.
391 results