Citation
Ader, Florence, et al. "An Open-label Randomized Controlled Trial of the Effect of Lopinavir/ritonavir, Lopinavir/ritonavir Plus IFN-β-1a and Hydroxychloroquine in Hospitalized Patients With COVID-19." Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases, vol. 27, no. 12, 2021, pp. 1826-1837.
Ader F, Peiffer-Smadja N, Poissy J, et al. An open-label randomized controlled trial of the effect of lopinavir/ritonavir, lopinavir/ritonavir plus IFN-β-1a and hydroxychloroquine in hospitalized patients with COVID-19. Clin Microbiol Infect. 2021;27(12):1826-1837.
Ader, F., Peiffer-Smadja, N., Poissy, J., Bouscambert-Duchamp, M., Belhadi, D., Diallo, A., Delmas, C., Saillard, J., Dechanet, A., Mercier, N., Dupont, A., Alfaiate, T., Lescure, F. X., Raffi, F., Goehringer, F., Kimmoun, A., Jaureguiberry, S., Reignier, J., Nseir, S., ... Mentré, F. (2021). An open-label randomized controlled trial of the effect of lopinavir/ritonavir, lopinavir/ritonavir plus IFN-β-1a and hydroxychloroquine in hospitalized patients with COVID-19. Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases, 27(12), 1826-1837. https://doi.org/10.1016/j.cmi.2021.05.020
Ader F, et al. An Open-label Randomized Controlled Trial of the Effect of Lopinavir/ritonavir, Lopinavir/ritonavir Plus IFN-β-1a and Hydroxychloroquine in Hospitalized Patients With COVID-19. Clin Microbiol Infect. 2021;27(12):1826-1837. PubMed PMID: 34048876.
TY - JOUR
T1 - An open-label randomized controlled trial of the effect of lopinavir/ritonavir, lopinavir/ritonavir plus IFN-β-1a and hydroxychloroquine in hospitalized patients with COVID-19.
AU - Ader,Florence,
AU - Peiffer-Smadja,Nathan,
AU - Poissy,Julien,
AU - Bouscambert-Duchamp,Maude,
AU - Belhadi,Drifa,
AU - Diallo,Alpha,
AU - Delmas,Christelle,
AU - Saillard,Juliette,
AU - Dechanet,Aline,
AU - Mercier,Noémie,
AU - Dupont,Axelle,
AU - Alfaiate,Toni,
AU - Lescure,François-Xavier,
AU - Raffi,François,
AU - Goehringer,François,
AU - Kimmoun,Antoine,
AU - Jaureguiberry,Stéphane,
AU - Reignier,Jean,
AU - Nseir,Saad,
AU - Danion,François,
AU - Clere-Jehl,Raphael,
AU - Bouiller,Kévin,
AU - Navellou,Jean-Christophe,
AU - Tolsma,Violaine,
AU - Cabié,André,
AU - Dubost,Clément,
AU - Courjon,Johan,
AU - Leroy,Sylvie,
AU - Mootien,Joy,
AU - Gaci,Rostane,
AU - Mourvillier,Bruno,
AU - Faure,Emmanuel,
AU - Pourcher,Valérie,
AU - Gallien,Sébastien,
AU - Launay,Odile,
AU - Lacombe,Karine,
AU - Lanoix,Jean-Philippe,
AU - Makinson,Alain,
AU - Martin-Blondel,Guillaume,
AU - Bouadma,Lila,
AU - Botelho-Nevers,Elisabeth,
AU - Gagneux-Brunon,Amandine,
AU - Epaulard,Olivier,
AU - Piroth,Lionel,
AU - Wallet,Florent,
AU - Richard,Jean-Christophe,
AU - Reuter,Jean,
AU - Staub,Thérèse,
AU - Lina,Bruno,
AU - Noret,Marion,
AU - Andrejak,Claire,
AU - Lê,Minh Patrick,
AU - Peytavin,Gilles,
AU - Hites,Maya,
AU - Costagliola,Dominique,
AU - Yazdanpanah,Yazdan,
AU - Burdet,Charles,
AU - Mentré,France,
AU - ,,
Y1 - 2021/05/26/
PY - 2021/3/17/received
PY - 2021/5/6/revised
PY - 2021/5/9/accepted
PY - 2021/5/29/pubmed
PY - 2021/12/24/medline
PY - 2021/5/28/entrez
KW - COVID-19
KW - Hydroxychloroquine
KW - Interferon β-1a
KW - Lopinavir/ritonavir
KW - Randomized controlled trial
KW - SARS-CoV-2
SP - 1826
EP - 1837
JF - Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
JO - Clin Microbiol Infect
VL - 27
IS - 12
N2 - OBJECTIVES: We evaluated the clinical, virological and safety outcomes of lopinavir/ritonavir, lopinavir/ritonavir-interferon (IFN)-β-1a, hydroxychloroquine or remdesivir in comparison to standard of care (control) in coronavirus 2019 disease (COVID-19) inpatients requiring oxygen and/or ventilatory support. METHODS: We conducted a phase III multicentre, open-label, randomized 1:1:1:1:1, adaptive, controlled trial (DisCoVeRy), an add-on to the Solidarity trial (NCT04315948, EudraCT2020-000936-23). The primary outcome was the clinical status at day 15, measured by the WHO seven-point ordinal scale. Secondary outcomes included quantification of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in respiratory specimens and pharmacokinetic and safety analyses. We report the results for the lopinavir/ritonavir-containing arms and for the hydroxychloroquine arm, trials of which were stopped prematurely. RESULTS: The intention-to-treat population included 583 participants-lopinavir/ritonavir (n = 145), lopinavir/ritonavir-IFN-β-1a (n = 145), hydroxychloroquine (n = 145), control (n = 148)-among whom 418 (71.7%) were male, the median age was 63 years (IQR 54-71), and 211 (36.2%) had a severe disease. The day-15 clinical status was not improved with the investigational treatments: lopinavir/ritonavir versus control, adjusted odds ratio (aOR) 0.83, (95% confidence interval (CI) 0.55-1.26, p 0.39), lopinavir/ritonavir-IFN-β-1a versus control, aOR 0.69 (95%CI 0.45-1.04, p 0.08), and hydroxychloroquine versus control, aOR 0.93 (95%CI 0.62-1.41, p 0.75). No significant effect of investigational treatment was observed on SARS-CoV-2 clearance. Trough plasma concentrations of lopinavir and ritonavir were higher than those expected, while those of hydroxychloroquine were those expected with the dosing regimen. The occurrence of serious adverse events was significantly higher in participants allocated to the lopinavir/ritonavir-containing arms. CONCLUSION: In adults hospitalized for COVID-19, lopinavir/ritonavir, lopinavir/ritonavir-IFN-β-1a and hydroxychloroquine improved neither the clinical status at day 15 nor SARS-CoV-2 clearance in respiratory tract specimens.
SN - 1469-0691
UR - https://www.unboundmedicine.com/medline/citation/34048876/An_open_label_randomized_controlled_trial_of_the_effect_of_lopinavir/ritonavir_lopinavir/ritonavir_plus_IFN_β_1a_and_hydroxychloroquine_in_hospitalized_patients_with_COVID_19_
DB - PRIME
DP - Unbound Medicine
ER -
