Gérain Jean, Uebelhoer Melanie, Costes Bérénice, Herman Julie, Pietri Sandra, Donneau Anne-Françoise, Monseur Justine, Henrotin Yves
Department of Internal Medicine, CHIREC Hospital Group, Brussels, Belgium.
Artialis SA, Avenue Hippocrate 5, Liège, Belgium.
Front Nutr. 2023 Jun 22;10:1137407. doi: 10.3389/fnut.2023.1137407. eCollection 2023.
The effect and safety of Nasafytol, a food supplement combining curcumin, quercetin, and Vitamin D, on hospitalized COVID-19-positive patients as support to standard of care were to be assessed.
This exploratory, open-label, randomized, controlled trial was carried out among hospitalized adults with COVID-19 infection. Participants were randomly assigned to receive Nasafytol or Fultium control. The improvement of the clinical condition and occurrence of (serious) adverse events were evaluated. The study was registered on clincaltrials.gov with the identifier NCT04844658.
Twenty-five patients received Nasafytol, and 24 received Fultium. Demographic characteristics were well balanced between the groups. On day 14 (or at hospital leave if < 14 days), no difference was observed between groups regarding their clinical condition, fever, or the need of oxygen therapy. At day 7, however, 19 participants had been discharged from the hospital in the Nasafytol arm compared to 10 participants in the Fultium arm. No participants were transferred to the ICU or died in the Nasafytol arm, vs. 4 transfers and 1 death in the Fultium arm. The clinical condition of participants in the Nasafytol arm had improved, as evidenced by a decrease in the COVID-19 WHO score. Interestingly, five SAEs occurred with Fultium, while no SAE was observed with Nasafytol.
Supplementation with Nasafytol, in addition to standard-of-care treatment, led to a faster discharge from the hospital, improved clinical conditions of participants, and a reduced risk of serious outcomes, including transfer to the intensive care unit or death, in patients hospitalized with COVID-19.
评估一种含有姜黄素、槲皮素和维生素D的食品补充剂Nasafytol对住院的新冠病毒检测呈阳性患者作为标准治疗辅助手段的疗效和安全性。
这项探索性、开放标签、随机对照试验在住院的新冠病毒感染成年患者中进行。参与者被随机分配接受Nasafytol或Fultium对照。评估临床状况的改善情况和（严重）不良事件的发生情况。该研究已在clinicaltrials.gov上注册，标识符为NCT04844658。
25名患者接受了Nasafytol，24名患者接受了Fultium。两组之间的人口统计学特征平衡良好。在第14天（或如果住院时间<14天则在出院时），两组在临床状况、发热或吸氧需求方面没有差异。然而，在第7天，接受Nasafytol治疗的组中有19名参与者出院，而接受Fultium治疗的组中有10名参与者出院。接受Nasafytol治疗的组中没有参与者被转至重症监护病房或死亡，而接受Fultium治疗的组中有4人被转至重症监护病房且1人死亡。接受Nasafytol治疗的组中参与者的临床状况有所改善，这体现在新冠病毒WHO评分降低。有趣的是，接受Fultium治疗的组出现了5例严重不良事件，而接受Nasafytol治疗的组未观察到严重不良事件。
对于住院的新冠病毒患者，除了标准治疗外，补充Nasafytol可使患者更快出院，改善参与者的临床状况，并降低包括转至重症监护病房或死亡在内的严重后果风险。
