tetano
Editor, Senior Moderator
Eur Respir J
. 2021 Dec 16;2102518.
doi: 10.1183/13993003.02518-2021. Online ahead of print.
Effect of high versus low dose of dexamethasone on clinical worsening in patients hospitalised with moderate or severe COVID-19 Pneumonia: an open-label, randomised clinical trial
Manuel Taboada[SUP] 1 [/SUP], Nuria Rodríguez[SUP] 2 [/SUP], Pablo Manuel Varela[SUP] 3 [/SUP], María Teresa Rodríguez[SUP] 4 [/SUP], Romina Abelleira[SUP] 2 [/SUP], Amara González[SUP] 3 [/SUP], Ana Casal[SUP] 2 [/SUP], José Antonio Díaz Peromingo[SUP] 3 [/SUP], Adriana Lama[SUP] 2 [/SUP], María Jesús Domínguez[SUP] 3 [/SUP], Carlos Rábade[SUP] 2 [/SUP], Emilio Manuel Páez[SUP] 3 [/SUP], Vanessa Riveiro[SUP] 2 [/SUP], Hadrián Pernas[SUP] 3 [/SUP], María Del Carmen Beceiro[SUP] 3 [/SUP], Valentín Caruezo[SUP] 5 [/SUP], Alberto Naveira[SUP] 5 [/SUP], Agustín Cariñena[SUP] 5 [/SUP], Teresa Cabaleiro[SUP] 6 [/SUP], Ana Estany-Gestal[SUP] 6 [/SUP], Irene Zarra[SUP] 4 [/SUP], Antonio Pose[SUP] 3 [/SUP], Luis Valdés[SUP] 2 [/SUP], Julián Álvarez-Escudero[SUP] 5 [/SUP]
Affiliations
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 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.
. 2021 Dec 16;2102518.
doi: 10.1183/13993003.02518-2021. Online ahead of print.
Effect of high versus low dose of dexamethasone on clinical worsening in patients hospitalised with moderate or severe COVID-19 Pneumonia: an open-label, randomised clinical trial
Manuel Taboada[SUP] 1 [/SUP], Nuria Rodríguez[SUP] 2 [/SUP], Pablo Manuel Varela[SUP] 3 [/SUP], María Teresa Rodríguez[SUP] 4 [/SUP], Romina Abelleira[SUP] 2 [/SUP], Amara González[SUP] 3 [/SUP], Ana Casal[SUP] 2 [/SUP], José Antonio Díaz Peromingo[SUP] 3 [/SUP], Adriana Lama[SUP] 2 [/SUP], María Jesús Domínguez[SUP] 3 [/SUP], Carlos Rábade[SUP] 2 [/SUP], Emilio Manuel Páez[SUP] 3 [/SUP], Vanessa Riveiro[SUP] 2 [/SUP], Hadrián Pernas[SUP] 3 [/SUP], María Del Carmen Beceiro[SUP] 3 [/SUP], Valentín Caruezo[SUP] 5 [/SUP], Alberto Naveira[SUP] 5 [/SUP], Agustín Cariñena[SUP] 5 [/SUP], Teresa Cabaleiro[SUP] 6 [/SUP], Ana Estany-Gestal[SUP] 6 [/SUP], Irene Zarra[SUP] 4 [/SUP], Antonio Pose[SUP] 3 [/SUP], Luis Valdés[SUP] 2 [/SUP], Julián Álvarez-Escudero[SUP] 5 [/SUP]
Affiliations
- PMID: 34916266
- DOI: 10.1183/13993003.02518-2021
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 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.