Abstract
Background: 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.
Methods: 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).
Results: 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.
Conclusions: Among hospitalised COVID-19 patients needing oxygen therapy, high dose of dexamethasone reduced clinical worsening within 11 days after randomisation, compared with low dose.
【초록키워드】 COVID-19, Dexamethasone, coronavirus disease, Efficacy, High dose, Open-label, randomised, Pneumonia, 28-day mortality, oxygen, outcome, clinical status, low-dose, low dose, male, Patient, Controlled trial, death, Oxygen therapy, Clinical improvement, age, Time to recovery, Evidence, High-dose, Primary outcome, 95% CI, no significant difference, randomisation, high-dose group, worsening, secondary, Randomly, seven-point ordinal scale, enrolled, performed, reduced, demonstrated, hospitalised patient, assigned, discharged, receive, 1:1, hospitalised COVID-19 patient, 【제목키워드】 Dexamethasone, clinical trial, Open-label, randomised, severe COVID-19, low dose, Patient, moderate, worsening, Effect, hospitalised,