Taboada Muñiz, ManuelRodríguez Núñez, NuriaManuel Varela, PabloRodríguez, María TeresaAbelleira París, RominaGonzález Noya, AmaraCasal Mouriño, AnaDíaz Peromingo, José AntonioLama López, AdrianaDomínguez, María JesúsRábade Castedo, CarlosPáez Guillán, Emilio ManuelRiveiro Blanco, VanessaPernas Pardavila, HadriánBeceiro, María del CarmenCaruezo Rodríguez, ValentínNaveira Castelo, AlbertoCariñena Amigo, AgustínCabaleiro Ocampo, TeresaEstany Gestal, AnaZarra Ferro, IrenePose Reino, AntonioValdés Cuadrado, LuisÁlvarez Escudero, Julián2026-01-142026-01-142022-08Taboada, M., Rodríguez, N., Varela, P. M., Rodríguez, M. T., Abelleira, R., González, A., Casal, A., Díaz Peromingo, J. A., Lama, A., Domínguez, M. J., Rábade, C., Páez, E. M., Riveiro, V., Pernas, H., Beceiro, M. del C., Caruezo, V., Naveira, A., Cariñena, A., Cabaleiro, T., … Álvarez-Escudero, J. (2022). 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. The European Respiratory Journal, 60(2), 2102518. https://doi.org/10.1183/13993003.02518-20210903-1936https://hdl.handle.net/10347/45133Background: 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. Trial registration: ClinicalTrials.gov NCT04726098.eng©The authors 2022. This version is distributed under the terms of the Creative Commons Attribution NonCommercial Licence 4.0. For commercial reproduction rights and permissions contact permissions@ersnet.orgAttribution-NonCommercial-ShareAlike 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-sa/4.0/COVID-19DexamethasoneOxygenTreatment Outcome320505 Enfermedades infecciosas320508 Enfermedades pulmonaresjournal article10.1183/13993003.02518-20211399-3003open access