未经批准:研究静脉注射维生素C治疗中重度COVID-19的疗效。
未经批准:确定静脉注射维生素C在降低COVID-19中重度病例住院死亡率方面的疗效。
UNASSIGNED:并行,安慰剂的双盲随机对照试验.从机构伦理委员会获得了伦理许可,AIIMSPatna.该试验已在印度临床试验注册中心注册(注册编号-CTRI/2020/11/029230。).
未经评估:比哈尔邦的三级护理中心,印度。
未经评估:所有18岁以上的患者,无论男女,在研究期间(2020年01月10日-2020年12月31日)在我们的机构入住ICU,诊断为中度和重度COVID-19(基于逆转录酶聚合酶链反应(RT-PCR)阳性报告),不符合任何排除标准.
UNASSIGNED:干预组的患者每8小时给予1克(2安瓿,每瓶2毫升,含500毫克维生素C混合在100毫升生理盐水中)静脉注射维生素C,持续4天。安慰剂组的患者每8小时静脉内接受相似的安瓿(2安瓿的2ml无菌注射用水,混合在100ml生理盐水中),持续4天。其余的治疗按照研究所的标准操作程序(SOP)进行,并根据治疗团队的判断进行调整。
未经证实:主要结局是降低住院死亡率。次要结果是qSOFA评分改善,pO2/fiO2比值,炎症标志物下降,需要机械通气和血管加压药。
未经评估:关于主要结果,干预组死亡10例(33.3%),安慰剂组死亡13例(43.3%)。从基线特征值得注意的是,干预组中86.7%的患者属于严重类别,而安慰剂组中66.7%的患者属于严重类别。尽管干预组的重症病例数量较多,但该组的死亡率相对较低。关于次要结果,在维生素C组的30名患者中,安慰剂组有11例(36.7%)需要有创机械通气,而安慰剂组30例中有14例(46.7%)需要机械通气,但差异无统计学意义。尽管安慰剂组的中度病例数量较多,有创通气需求(和NIV需求)在该组中更多,因此,可以认为维生素C可能具有降低疾病严重程度的作用。与安慰剂组的26.7%相比,干预组的血管加压药治疗的需求更高,为33.3%,但在统计学上不显着。研究的次要结果,例如器官衰竭评分(qSOFA评分)的改善,炎症标志物水平下降,呼吸指数(pO2/fiO2比)的改善,需要机械通气和需要血管加压药也显示出令人鼓舞的结果,但由于药物剂量适中和样本量小,未达到统计学上的显着水平。
未经评估:在当前的研究中,根据双盲安慰剂对照随机试验的观察和结果,我们得出的结论是,作为这项研究的主要结果,与安慰剂相比,维生素C干预组的住院死亡率和机械通气需求降低,尽管由于样本量小和使用中等剂量的IV维生素C,这些结果没有达到统计学意义。研究的次要结果,例如器官衰竭评分(qSOFA评分)的改善,炎症标志物水平下降,呼吸指数(pO2/fiO2比)的改善,需要机械通气和需要血管加压药也显示出令人鼓舞的结果,但由于药物剂量适中和样本量小,未达到统计学上的显着水平。总之,大剂量静脉注射维生素C可以减少炎症反应,改善氧气支持状态,并降低COVID-19患者的死亡率,无不良事件。大剂量静脉注射维生素C可能是中度至重度COVID-19患者的有希望的治疗方法。
UNASSIGNED: To study the efficacy of intravenous vitamin C in management of moderate and severe COVID-19.
UNASSIGNED: To determine the efficacy of intravenous vitamin C in reducing in-hospital mortality in moderate and severe cases of COVID-19.
UNASSIGNED: Parallel, double-blinded randomized controlled trial with placebo. Ethical clearance was obtained from the institutional ethics committee, AIIMS Patna. The trial was registered with the Clinical Trials Registry - India (registration number- CTRI/2020/11/029230.).
UNASSIGNED: A tertiary care centre in Bihar, India.
UNASSIGNED: All patients above the age of 18 years both males and females, admitted in ICU with a diagnosis of moderate and severe COVID-19 (on the basis of a positive reverse transcriptase polymerase chain reaction (RT-PCR) report) at our facility during the study period (01/10/2020-31/12/2020) not having any of the exclusion criteria.
UNASSIGNED: The patients in the intervention arm were given 1 gram (2 ampoules of 2 ml each containing 500 mg of vitamin C mixed in 100 ml normal saline) intravenous vitamin C 8 hourly for four days. The patients in the placebo arm received similar looking ampoules (2 ampoules of 2 ml sterile water for injection mixed in 100 ml normal saline) intravenously 8 hourly for four days. The rest of the treatment was given as per the standard operating procedure (SOP) of the institute with adjustments as per treating team\'s judgement.
UNASSIGNED: Primary outcome was reduction in in-hospital mortality. Secondary outcomes were improvement in qSOFA score, pO2/fiO2 ratio, fall in inflammatory markers, need for mechanical ventilation and vasopressors.
UNASSIGNED: Regarding primary outcome, 10 (33.3%) patients died in intervention group compared to 13 (43.3%) in placebo. Worth noting from baseline characteristics is that 86.7% in intervention arm were of severe category compared to 66.7% severe category patients in placebo group. Though number of severe cases were more in intervention arm there has been comparatively less mortality in this group. Regarding secondary outcomes, amongst 30 patients in vitamin C group, 11 (36.7%) required invasive mechanical ventilation compared to 14 (46.7%) out of 30 in placebo group but the difference was not statistically significant. Although there were a greater number of moderate cases in placebo group, invasive ventilation requirement (and NIV requirement) was more in this group, thus it could be considered that vitamin C might have a role in reducing the severity of disease. The need for vasopressor therapy was higher in intervention arm 33.3% compared to 26.7% in placebo but not significant statistically. The secondary outcomes of the study such as improvement in organ failure score (qSOFA Score), fall in level of inflammatory markers, improvement in respiratory index (pO2/fiO2 ratio), need for mechanical ventilation and need for vasopressors also shown encouraging results but not up to the statistically significant level due to moderate dosage of the drug and small sample size.
UNASSIGNED: In the current study, by the observations and results of the double-blind placebo controlled randomised trial, we concluded that as the primary outcome of the study, there was reduction in In-hospital mortality and need for mechanical ventilation in the vitamin C intervention group compared to placebo, although these results did not reach statistical significance due to small sample size and use of moderate dose of IV vitamin C. The secondary outcomes of the study such as improvement in organ failure score (qSOFA Score), fall in level of inflammatory markers, improvement in respiratory index (pO2/fiO2 ratio), need for mechanical ventilation and need for vasopressors also shown encouraging results but not up to the statistically significant level due to moderate dosage of the drug and small sample size. In summary, high dose of intravenous vitamin C may reduce inflammatory reaction, improve oxygen support status, and reduce mortality in COVID-19 patients, without adverse events. High dose intravenous vitamin C may be a promising therapy for patients of moderate to severe COVID-19.