Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
@article{HorbyMafhamBellLinsellStaplinEmbersonPalfree2, title={Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial}, author={Peter W Marion Jennifer L Louise Natalie Jonathan Adrian Horby Mafham Bell Linsell Staplin Emberson Palfree and Peter W. Horby and Marion M. Mafham and Jennifer L. Bell and Louise Linsell and Natalie Staplin and Jonathan R. Emberson and Adrian Palfreeman and Jason Raw and Einas Elmahi and Benjamin Prudon and Christopher A. Green and Simon Carley and David R. Chadwick and Matthew Davies and Matthew P. Wise and John Kenneth Baillie and Lucy C. Chappell and Saul N. Faust and Thomas F. Jaki and Katie Jefferey and Wei Shen Lim and Alan A. Montgomery and Kathryn M. Rowan and Edmund Juszczak and Richard Haynes and Martin J Landray}, journal={Lancet (London, England)}, year={2020}, volume={396}, pages={1345 - 1352} }
440 Citations
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Trough plasma concentrations of lopinavir and ritonavir were higher than those expected, while those of hydroxychloroquine were those expected with the dosing regimen, and the occurrence of Serious Adverse Events was significantly higher in participants allocated to the lOPinavir/ritonavir-containing arms.
References
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In hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir–ritonavir treatment beyond standard care, and future trials in patients withsevere illness may help to confirm or exclude the possibility of a treatment benefit.
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In critically ill patients admitted for SARS-CoV-2-related pneumonia, no difference was found between hydroxychloroquine or lopinavir/ritonavir as compared to standard of care only on the proportion of patients who needed treatment escalation at day 28.
Pharmacokinetics of lopinavir/ritonavir oral solution to treat COVID-19 in mechanically ventilated ICU patients
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In mechanically ventilated patients with severe COVID-19 infections, the oral administration of lopinavir/ritonavir elicited plasma exposure of lupinavir more than 6-fold the upper usual expected range, however, it remains difficult to safely recommend its dose reduction without compromising the benefit of the antiviral strategy.
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The apparent favourable clinical response with lopinavir/ritonavir and ribavirin supports further randomised placebo controlled trials in patients with SARS and shows that age, hepatitis B carrier status, and lack of treatment with this antiviral combination were independent predictors of an adverse outcome.
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Pharmacokinetics of Lopinavir and Ritonavir in Patients Hospitalized With Coronavirus Disease 2019 (COVID-19)
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T trough levels of lopinavir and ritonavir are quantified by liquid chromatography–tandem mass spectrometry in patients admitted to a “normal care” ward because of COVID-19, finding that steady-state conditions may be assumed for all patients.
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Overall, there was no clear benefit for the use of lopinavir-ritonavir compared to standard of care in severe COVID-19 and the benefit-risk profile cannot be considered positive until further efficacy and effectiveness data become available.
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Older age and the lack of LPV/r treatment were independently associated with prolonged SARS-CoV-2 RNA shedding in patients with coronavirus disease 2019 (COVID-19) and earlier administration of lopinavir/ritonavir treatment could shorten viral shedding duration.
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Administration of crushed 200/50 mg lopinavir/ritonavir tablets to children significantly reduced lopvinir and ritonavir exposure with a decrease in AUC by 45% and 47%, respectively.
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Compared with the treatment of pneumonia-associated adjuvant drugs alone, the combination treatment with LPV/r and adjUvant drugs has a more evident therapeutic effect in lowering the body temperature and restoring normal physiological mechanisms with no evident toxic and side effects.