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, Rodriguez-Moreno, Juan Francisco, 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 ; volume 14 ; ISSN 1664-3224 |
| بيانات النشر: |
Frontiers Media SA |
| سنة النشر: |
2023 |
| المجموعة: |
Frontiers (Publisher - via CrossRef) |
| مصطلحات موضوعية: |
Immunology, Immunology and Allergy |
| الوصف: |
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.govTest/ , identifier NCT04348695. |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
unknown |
| DOI: |
10.3389/fimmu.2023.1156603 |
| DOI: |
10.3389/fimmu.2023.1156603/full |
| الإتاحة: |
https://doi.org/10.3389/fimmu.2023.1156603Test |
| حقوق: |
https://creativecommons.org/licenses/by/4.0Test/ |
| رقم الانضمام: |
edsbas.88CCE785 |
| قاعدة البيانات: |
BASE |
