Pilot trial of high-dose vitamin C in critically ill COVID-19 patients.
Pilot trial of high-dose vitamin C in critically ill COVID-19 patients.
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DOI：
10.1186/s13613-020-00792-3
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发表时间：
2021-01-09
影响因子：
8.1
通讯作者：
Peng Z
中科院分区：
文献类型：
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作者：
Zhang J;Rao X;Li Y;Zhu Y;Liu F;Guo G;Luo G;Meng Z;De Backer D;Xiang H;Peng Z
很少有特定药物被证明对治疗 2019 年新型冠状病毒病 (COVID-19) 患者有效。在这里，我们测试了大剂量维生素 C 输注对于重症 COVID-19 是否有效。这项随机对照临床试验在中国湖北省的 3 家医院进行。 ICU 中确诊的严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 感染患者按 1:1 的比例随机分配接受高剂量静脉注射维生素 C (HDIVC) 或安慰剂。 HDIVC组以12ml/小时的速度每12小时注射12g维生素C/50ml，连续7天，安慰剂组在到达ICU后48小时内以同样的方式注射抑菌注射用水。主要结局是 28 天内无有创机械通气的天数 (IMVFD28)。次要结局是 28 天死亡率、器官衰竭（序贯器官衰竭评估 (SOFA) 评分）和炎症进展（白介素-6）。由于疫情得到早期控制，最终仅招募了 56 名危重 COVID-19 患者。两组之间的 IMVFD28 没有差异（HDIVC 为 26.0 [9.0–28.0]，对照组为 22.0 [8.50–28.0]，p = 0.57）。 HDIVC 未能降低 28 天死亡率（P = 0.27）。在 7 天的治疗期间，HDIVC 组患者的 PaO2/FiO2 稳步上升（第 7 天：229 vs. 151 mmHg，95% CI 33 至 122，P = 0.01），而对照组则没有观察到这一点。第 7 天，HDIVC 组的 IL-6 低于对照组（19.42 vs. 158.00；95% CI -301.72 至 -29.79；P = 0.04）。这项试点试验表明，HDIVC 未能改善 IMVFD28，但可能显示出对 COVID-19 重症患者改善 PaO2/FiO2 的氧合有益的潜在信号即使。
Few specific medications have been proven effective for the treatment of patients with severe coronavirus disease 2019 (COVID-19). Here, we tested whether high-dose vitamin C infusion was effective for severe COVID-19. This randomized, controlled, clinical trial was performed at 3 hospitals in Hubei, China. Patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the ICU were randomly assigned in as 1:1 ratio to either the high-dose intravenous vitamin C (HDIVC) or the placebo. HDIVC group received 12 g of vitamin C/50 ml every 12 h for 7 days at a rate of 12 ml/hour, and the placebo group received bacteriostatic water for injection in the same way within 48 h of arrival to ICU. The primary outcome was invasive mechanical ventilation-free days in 28 days (IMVFD28). Secondary outcomes were 28-day mortality, organ failure (Sequential Organ Failure Assessment (SOFA) score), and inflammation progression (interleukin-6). Only 56 critical COVID-19 patients were ultimately recruited due to the early control of the outbreak. There was no difference in IMVFD28 between two groups (26.0 [9.0–28.0] in HDIVC vs 22.0 [8.50–28.0] in control, p = 0.57). HDIVC failed to reduce 28-day mortality (P = 0.27). During the 7-day treatment period, patients in the HDIVC group had a steady rise in the PaO2/FiO2 (day 7: 229 vs. 151 mmHg, 95% CI 33 to 122, P = 0.01), which was not observed in the control group. IL-6 in the HDIVC group was lower than that in the control group (19.42 vs. 158.00; 95% CI -301.72 to -29.79; P = 0.04) on day 7. This pilot trial showed that HDIVC failed to improve IMVFD28, but might show a potential signal of benefit in oxygenation for critically ill patients with COVID-19 improving PaO2/FiO2 even though.