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.

Autor:	Taboada M; Dept of Anesthesiology and Intensive Care Medicine, Clinical University Hospital of Santiago, Sanitary Research Institute of Santiago (IDIS), Santiago de Compostela, Spain manutabo@yahoo.es., Rodríguez N; Dept of Pneumology, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., Varela PM; Dept Internal Medicine, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., Rodríguez MT; Dept Pharmacology, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., Abelleira R; Dept of Pneumology, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., González A; Dept Internal Medicine, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., Casal A; Dept of Pneumology, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., Díaz Peromingo JA; Dept Internal Medicine, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., Lama A; Dept of Pneumology, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., Domínguez MJ; Dept Internal Medicine, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., Rábade C; Dept of Pneumology, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., Páez EM; Dept Internal Medicine, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., Riveiro V; Dept of Pneumology, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., Pernas H; Dept Internal Medicine, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., Beceiro MDC; Dept Internal Medicine, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., Caruezo V; Dept of Anesthesiology and Intensive Care Medicine, Clinical University Hospital of Santiago, Sanitary Research Institute of Santiago (IDIS), Santiago de Compostela, Spain., Naveira A; Dept of Anesthesiology and Intensive Care Medicine, Clinical University Hospital of Santiago, Sanitary Research Institute of Santiago (IDIS), Santiago de Compostela, Spain., Cariñena A; Dept of Anesthesiology and Intensive Care Medicine, Clinical University Hospital of Santiago, Sanitary Research Institute of Santiago (IDIS), Santiago de Compostela, Spain., Cabaleiro T; Research Methodology Unit, Fundación Instituto de Investigaciones Sanitarias (FIDIS), Santiago de Compostela, Spain., Estany-Gestal A; Research Methodology Unit, Fundación Instituto de Investigaciones Sanitarias (FIDIS), Santiago de Compostela, Spain., Zarra I; Dept Pharmacology, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., Pose A; Dept Internal Medicine, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., Valdés L; Dept of Pneumology, Clinical University Hospital of Santiago, Santiago de Compostela, Spain., Álvarez-Escudero J; Dept of Anesthesiology and Intensive Care Medicine, Clinical University Hospital of Santiago, Sanitary Research Institute of Santiago (IDIS), Santiago de Compostela, Spain.
Jazyk:	angličtina
Zdroj:	The European respiratory journal [Eur Respir J] 2022 Aug 04; Vol. 60 (2). Date of Electronic Publication: 2022 Aug 04 (Print Publication: 2022).
DOI:	10.1183/13993003.02518-2021
Abstrakt:	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. Competing Interests: Conflict of interest: The authors declare the absence of conflict of interests. (Copyright ©The authors 2022.)
Databáze:	MEDLINE
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