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dc.contributor.authorSolanich, Xavier
dc.contributor.authorAntolí, Arnau
dc.contributor.authorRocamora-Blanch, Gemma
dc.contributor.authorPadullés, Núria
dc.contributor.authorFanlo-Maresma, Marta
dc.contributor.authorIriarte, Adriana
dc.contributor.authorMitjavila, Francesca
dc.contributor.authorCapdevila, Olga
dc.contributor.authorRiera-Mestre, Antoni
dc.contributor.authorBas, Jordi
dc.contributor.authorVicens-Zygmunt, Vanesa
dc.contributor.authorNiubó, Jordi
dc.contributor.authorCalvo, Nahum
dc.contributor.authorBolivar, Santiago
dc.contributor.authorRigo-Bonnin, Raúl
dc.contributor.authorMensa-Vilaró, Anna
dc.contributor.authorArregui, Laura
dc.contributor.authorTebé, Cristian
dc.contributor.authorVidela, Sebastià
dc.contributor.authorHereu, Pilar
dc.contributor.authorCorbella, Xavier
dc.date.accessioned2021-07-20T13:26:03Z
dc.date.available2021-07-20T13:26:03Z
dc.date.issued2021
dc.identifier.citationSolanich, Xavier; Antolí, Arnau; Rocamora-Blanch, Gemma [et al.]. Methylprednisolone pulses plus tacrolimus in addition to standard of care vs. standard of care alone in patients with severe COVID-19. A randomized controlled trial. Frontiers in Medicine, 8, 691712. Disponible en: <https://www.frontiersin.org/articles/10.3389/fmed.2021.691712/full>. Fecha de acceso: 20 jul 2021. DOI: 10.3389/fmed.2021.691712ca
dc.identifier.issn2095-0217ca
dc.identifier.urihttp://hdl.handle.net/20.500.12328/2692
dc.description.abstractIntroduction: Severe lung injury is triggered by both the SARS-CoV-2 infection and the subsequent host-immune response in some COVID-19 patients. Methods: We conducted a randomized, single-center, open-label, phase II trial with the aim to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus plus standard of care (SoC) vs. SoC alone, in hospitalized patients with severe COVID-19. The primary outcome was time to clinical stability within 56 days after randomization. Results: From April 1 to May 2, 2020, 55 patients were prospectively included for subsequent randomization; 27 were assigned to the experimental group and 28 to the control group. The experimental treatment was not associated with a difference in time to clinical stability (hazard ratio 0.73 [95% CI 0.39–1.37]) nor most secondary outcomes. Median methylprednisolone cumulative doses were significantly lower (360 mg [IQR 360–842] vs. 870 mg [IQR 364–1451]; p = 0.007), and administered for a shorter time (median of 4.00 days [3.00–17.5] vs. 18.5 days [3.00–53.2]; p = 0.011) in the experimental group than in the control group. Although not statistically significant, those receiving the experimental therapy showed a numerically lower all-cause mortality than those receiving SoC, especially at day 10 [2 (7.41%) vs. 5 (17.9%); OR 0.39 (95% CI 0.05–2.1); p = 0.282]. The total number of non-serious adverse events was 42 in each the two groups. Those receiving experimental treatment had a numerically higher rate of non-serious infectious adverse events [16 (38%) vs. 10 (24%)] and serious infectious adverse events [7 (35%) vs. 3 (23%)] than those receiving SoC. Conclusions: The combined use of methylprednisolone pulses plus tacrolimus, in addition to the SoC, did not significantly improve the time to clinical stability or other secondary outcomes compared with the SoC alone in severe COVID-19. Although not statistically significant, patients receiving the experimental therapy had numerically lower all-cause mortality than those receiving SoC, supporting recent non-randomized studies with calcineurin inhibitors. It is noteworthy that the present trial had a limited sample size and several other limitations. Therefore, further RCTs should be done to assess the efficacy and safety of tacrolimus to tackle the inflammatory stages of COVID-19.en
dc.format.extent11ca
dc.language.isoengca
dc.publisherFrontiers Mediaca
dc.relation.ispartofFrontiers in Medicineca
dc.relation.ispartofseries8;
dc.rights© 2021 Solanich, Antolí, Rocamora-Blanch, Padullés, Fanlo-Maresma, Iriarte, Mitjavila, Capdevila, Riera-Mestre, Bas, Vicens-Zygmunt, Niubó, Calvo, Bolivar, Rigo-Bonnin, Mensa-Vilaró, Arregui, Tebe, Videla, Hereu and Corbella. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.en
dc.subject.otherCOVID-19 (malaltia)ca
dc.subject.otherSARS-CoV-2ca
dc.subject.otherMetilprednisolonaca
dc.subject.otherTacrolimusca
dc.subject.otherInflamacióca
dc.subject.otherLesió pulmonarca
dc.subject.otherCOVID-19es
dc.subject.otherSARS-CoV-2es
dc.subject.otherMetilprednisolonaes
dc.subject.otherTacrolimuses
dc.subject.otherInflamaciónes
dc.subject.otherLesión pulmonares
dc.subject.otherCOVID-19en
dc.subject.otherSARS-CoV-2en
dc.subject.otherMethylprednisoloneen
dc.subject.otherTacrolimusen
dc.subject.otherInflammationen
dc.subject.otherLung injuryen
dc.titleMethylprednisolone pulses plus tacrolimus in addition to standard of care vs. standard of care alone in patients with severe COVID-19. A randomized controlled trialen
dc.typeinfo:eu-repo/semantics/articleca
dc.description.versioninfo:eu-repo/semantics/publishedVersionca
dc.rights.accessLevelinfo:eu-repo/semantics/openAccess
dc.embargo.termscapca
dc.subject.udc61ca
dc.identifier.doihttps://dx.doi.org/10.3389/fmed.2021.691712ca


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