دورية أكاديمية

Randomized phase II clinical trial of ruxolitinib plus simvastatin in COVID19 clinical outcome and cytokine evolution.

التفاصيل البيبلوغرافية
العنوان: Randomized phase II clinical trial of ruxolitinib plus simvastatin in COVID19 clinical outcome and cytokine evolution.
المؤلفون: Garcia-Donas, Jesus, Martínez-Urbistondo, Diego, Velázquez Kennedy, Kyra, Villares, Paula, Barquin, Arántzazu, Dominguez, Andrea, Francisco Rodriguez-Moreno, Juan, Caro, Elena, Suarez del Villar, Rafael, Nistal-Villan, Estanislao, Yagüe, Monica, Ortiz, Maria, Barba, Maria, Ruiz-Llorente, Sergio, Quiralte, Miguel, Zanin, Massimiliano, Rodríguez, Cristina, Navarro, Paloma, Berraondo, Pedro, Madurga, Rodrigo
المصدر: Frontiers in Immunology; 5/2/2023, p1-12, 12p
مصطلحات موضوعية: SIMVASTATIN, SUPERVISED learning, COVID-19, RUXOLITINIB, CLINICAL trials
مستخلص: 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. [ABSTRACT FROM AUTHOR]
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قاعدة البيانات: Complementary Index
الوصف
تدمد:16643224
DOI:10.3389/fimmu.2023.1156603