Low-dose dexamethasone demonstrated clinical improvement in patients with coronavirus disease 2019 (COVID-19) needing oxygen therapy; however, evidence on the efficacy of high-dose dexamethasone is limited.

We performed a randomised, open-label, controlled trial involving hospitalised patients with confirmed COVID-19 pneumonia needing oxygen therapy. Patients were randomly assigned in a 1:1 ratio to receive low-dose dexamethasone (6 mg once daily for 10 days) or high-dose dexamethasone (20 mg once daily for 5 days, followed by 10 mg once daily for an additional 5 days). The primary outcome was clinical worsening within 11 days since randomisation. Secondary outcomes included 28-day mortality, time to recovery and clinical status at day 5, 11, 14 and 28 on an ordinal scale ranging from 1 (discharged) to 7 (death).

A total of 200 patients (mean±sd age 64±14 years; 62% male) were enrolled. 32 (31.4%) out of 102 patients enrolled in the low-dose group and 16 (16.3%) out of 98 in the high-dose group showed clinical worsening within 11 days since randomisation (rate ratio 0.427, 95% CI 0.216–0.842; p=0.014). The 28-day mortality was 5.9% in the low-dose group and 6.1% in the high-dose group (p=0.844). There was no significant difference in time to recovery, and in the seven-point ordinal scale at days 5, 11, 14 and 28.

Among hospitalised COVID-19 patients needing oxygen therapy, high dose of dexamethasone reduced clinical worsening within 11 days after randomisation, compared with low dose.

低剂量地塞米松在需要氧疗的 2019 年冠状病毒病 (COVID-19) 患者中表现出临床改善；然而，关于大剂量地塞米松疗效的证据有限。

我们进行了一项随机、开放标签、对照试验，涉及需要氧疗的确诊 COVID-19 肺炎住院患者。患者以 1:1 的比例随机分配接受低剂量地塞米松（6 mg，每天一次，共 10 天）或高剂量地塞米松（20 mg，每天一次，共 5 天，然后每天 10 mg，共 5 天） ）。主要结果是随机分组后 11 天内临床恶化。次要结果包括 28 天死亡率、恢复时间和第 5、11、14 和 28 天的临床状态，顺序范围从 1（出院）到 7（死亡）。

共有 200 名患者（平均值±sd年龄 64±14 岁；62% 男性）被录取。低剂量组 102 名患者中有 32 名（31.4%）和高剂量组 98 名患者中有 16 名（16.3%）在随机化后 11 天内出现临床恶化（比率 0.427，95% CI 0.216-0.842 ; p = 0.014)。低剂量组的 28 天死亡率为 5.9%，高剂量组为 6.1%（p=0.844）。恢复时间和第 5、11、14 和 28 天的 7 点顺序量表没有显着差异。

在需要氧疗的住院 COVID-19 患者中，与低剂量相比，高剂量地塞米松在随机化后 11 天内可减少临床恶化。