We performed a multicenter, randomized open-label trial in patients with moderate to severe Covid-19 treated with a range of possible treatment regimens. Methods: Patients were randomly assigned to one of three regimen groups at a ratio of 1:1:1. The primary outcome of this study was admission to the intensive care unit. Secondary outcomes were intubation, in-hospital mortality, time to clinical recovery, and length of hospital stay (LOS). Between April 13 and August 9, 2020, a total of 336 patients were randomly assigned to receive one of the 3 treatment regimens including group I (hydroxychloroquine stat, prednisolone, azithromycin and naproxen; 120 patients), group II (hydroxychloroquine stat, azithromycin and naproxen; 116 patients), and group III (hydroxychloroquine and lopinavir/ritonavir (116 patients). The mean LOS in patients receiving prednisolone was 5.5 in the modified intention-to-treat (mITT) population and 4.4 days in the per-protocol (PP) population compared with 6.4 days (mITT population) and 5.8 days (PP population) in patients treated with Lopinavir/Ritonavir. The mean LOS was significantly lower in the mITT and PP populations who received prednisolone compared with populations treated with Lopinavir/Ritonavir (p = 0.028; p = 0.0007). We observed no significant differences in the number of deaths, ICU admission, and need for mechanical ventilation between the Modified ITT and per-protocol populations treated with prednisolone and Lopinavir/Ritonavir, although these outcomes were better in the arm treated with prednisolone. The time to clinical recovery was similar in the modified ITT and per-protocol populations treated with prednisolone, lopinavir/ritonavir, and azithromycin (P = 0.335; P = 0.055; p = 0.291; p = 0.098). The results of the present study show that therapeutic regimen (regimen I) with low dose prednisolone was superior to other regimens in shortening the length of hospital stay in patients with moderate to severe COVID-19. The steroid sparing effect may be utilized to increase the effectiveness of corticosteroids in the management of diabetic patients by decreasing the dosage.

中文翻译：

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皮质类固醇治疗对中重度 SARS-CoV-2 感染患者的疗效：一项多中心、随机、开放标签试验

我们在接受一系列可能的治疗方案治疗的中度至重度 Covid-19 患者中进行了一项多中心、随机、开放标签试验。方法：将患者以 1:1:1 的比例随机分配到三个方案组之一。这项研究的主要结果是入住重症监护室。次要结果是插管、住院死亡率、临床恢复时间和住院时间 (LOS)。2020 年 4 月 13 日至 8 月 9 日期间，共有 336 名患者被随机分配接受 3 种治疗方案中的一种，包括 I 组（羟氯喹 stat、泼尼松龙、阿奇霉素和萘普生；120 名患者）、II 组（羟氯喹 stat、阿奇霉素和萘普生；116 名患者）和第三组（羟氯喹和洛匹那韦/利托那韦（116 名患者）。接受泼尼松龙治疗的患者的平均 LOS 在改良意向治疗 (mITT) 人群中为 5.5 天，在符合方案 (PP) 人群中为 4.4 天，而患者为 6.4 天（mITT 人群）和 5.8 天（PP 人群）用洛匹那韦/利托那韦治疗。与接受洛匹那韦/利托那韦治疗的人群相比，接受泼尼松龙治疗的 mITT 和 PP 人群的平均 LOS 显着降低（p = 0.028；p = 0.0007）。我们观察到，使用泼尼松龙和洛匹那韦/利托那韦治疗的改良 ITT 和符合方案人群在死亡人数、入住 ICU 和机械通气需求方面没有显着差异，尽管这些结果在用泼尼松龙治疗的手臂中更好。使用泼尼松龙、洛匹那韦/利托那韦和阿奇霉素治疗的改良 ITT 和符合方案人群的临床恢复时间相似（P = 0.335；P = 0.055；p = 0.291；p = 0.098）。本研究的结果表明，低剂量泼尼松龙的治疗方案（方案 I）在缩短中度至重度 COVID-19 患者的住院时间方面优于其他方案。类固醇节约效应可用于通过降低剂量来增加皮质类固醇在糖尿病患者治疗中的有效性。本研究的结果表明，低剂量泼尼松龙的治疗方案（方案 I）在缩短中度至重度 COVID-19 患者的住院时间方面优于其他方案。类固醇节约效应可用于通过降低剂量来增加皮质类固醇在糖尿病患者治疗中的有效性。本研究的结果表明，低剂量泼尼松龙的治疗方案（方案 I）在缩短中度至重度 COVID-19 患者的住院时间方面优于其他方案。类固醇节约效应可用于通过降低剂量来增加皮质类固醇在糖尿病患者治疗中的有效性。