Madurga, R. (Rodrigo)

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    Randomized phase II clinical trial of ruxolitinib plus simvastatin in COVID19 clinical outcome and cytokine evolution
    (Frontiers, 2023) Garcia-Donas, J. (Jesús); Martínez‑Urbistondo, D. (Diego); Villares, P. (Paula); Barquín, A. (Aranzazu); Domínguez, A. (Andrea); Rodríguez-Moreno, J.F. (Juan Francisco); Caro, E. (Elena); Suárez-del-Villar, R. (Rafael); Nistal-Villan, E. (Estanislao); Yagüe, M. (Mónica); Ortiz, M. (María); Barba, M. (María); Ruiz-Llorente, S. (Sergio); Quiralte, M. (Miguel); Zanin, M. (Massimiliano); Rodriguez, C. (Cristina); Navarro, P. (Paloma); Berraondo, P. (Pedro); Madurga, R. (Rodrigo)
    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. Trial registration: https://clinicaltrials.gov/, identifier NCT04348695.