TY - JOUR T1 - Effect of high <em>versus</em> low dose of dexamethasone on clinical worsening in patients hospitalised with moderate or severe COVID-19 Pneumonia: an open-label, randomised clinical trial JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.02518-2021 SP - 2102518 AU - Manuel Taboada AU - Nuria Rodríguez AU - Pablo Manuel Varela AU - María Teresa Rodríguez AU - Romina Abelleira AU - Amara González AU - Ana Casal AU - José Antonio Díaz Peromingo AU - Adriana Lama AU - María Jesús Domínguez AU - Carlos Rábade AU - Emilio Manuel Páez AU - Vanessa Riveiro AU - Hadrián Pernas AU - María del Carmen Beceiro AU - Valentín Caruezo AU - Alberto Naveira AU - Agustín Cariñena AU - Teresa Cabaleiro AU - Ana Estany-Gestal AU - Irene Zarra AU - Antonio Pose AU - Luis Valdés AU - Julián Álvarez-Escudero Y1 - 2021/01/01 UR - http://erj.ersjournals.com/content/early/2021/12/09/13993003.02518-2021.abstract N2 - 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 of 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 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. Thirty-two patients of 102 (31.4%) enrolled in the low dose group and 16 of 98 (16.3%) 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 7-point ordinal scale at day 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 as compared with low dose. ER -