dc.contributor.author | García-Donas, Jesús | |
dc.contributor.author | Martínez-Urbistondo, Diego | |
dc.contributor.author | Velázquez Kennedy, Kyra | |
dc.contributor.author | Madurga Lacalle, Rodrigo | |
dc.date.accessioned | 2024-02-28T20:51:36Z | |
dc.date.available | 2024-02-28T20:51:36Z | |
dc.date.issued | 2023 | |
dc.identifier.issn | 1664-3224 | spa |
dc.identifier.uri | https://hdl.handle.net/10641/4175 | |
dc.description.abstract | Background: Managing the inflammatory response to SARS-Cov-2 could prevent respiratory insufficiency. Cytokine profiles could identify cases at risk of severe disease.
Methods: We designed a randomized phase II clinical trial to determine whether the combination of ruxolitinib (5 mg twice a day for 7 days followed by 10 mg BID for 7 days) plus simvastatin (40 mg once a day for 14 days), could reduce the incidence of respiratory insufficiency in COVID-19. 48 cytokines were correlated with clinical outcome.
Participants: Patients admitted due to COVID-19 infection with mild disease.
Results: Up to 92 were included. Mean age was 64 ± 17, and 28 (30%) were female. 11 (22%) patients in the control arm and 6 (12%) in the experimental arm reached an OSCI grade of 5 or higher (p = 0.29). Unsupervised analysis of cytokines detected two clusters (CL-1 and CL-2). CL-1 presented a higher risk of clinical deterioration vs CL-2 (13 [33%] vs 2 [6%] cases, p = 0.009) and death (5 [11%] vs 0 cases, p = 0.059). Supervised Machine Learning (ML) analysis led to a model that predicted patient deterioration 48h before occurrence with a 85% accuracy.
Conclusions: Ruxolitinib plus simvastatin did not impact the outcome of COVID-19. Cytokine profiling identified patients at risk of severe COVID-19 and predicted clinical deterioration. | spa |
dc.language.iso | eng | spa |
dc.publisher | Frontiers in Immunology | spa |
dc.rights | Atribución-NoComercial-SinDerivadas 3.0 España | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/es/ | * |
dc.subject | COVID-19 | spa |
dc.subject | SARS-CoV-2 | spa |
dc.subject | Cytokine storm | spa |
dc.subject | Ruxolitinib | spa |
dc.subject | Simvastatin | spa |
dc.subject | Clinical trial | spa |
dc.title | Randomized phase II clinical trial of ruxolitinib plus simvastatin in COVID19 clinical outcome and cytokine evolution. | spa |
dc.type | journal article | spa |
dc.type.hasVersion | AM | spa |
dc.rights.accessRights | open access | spa |
dc.description.extent | 5586 KB | spa |
dc.identifier.doi | 10.3389/fimmu.2023.1156603 | spa |
dc.relation.publisherversion | https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2023.1156603/full | spa |