RT Journal Article T1 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 A1 Taboada Muñiz, Manuel A1 Rodríguez Núñez, Nuria A1 Manuel Varela, Pablo A1 Rodríguez, María Teresa A1 Abelleira París, Romina A1 González Noya, Amara A1 Casal Mouriño, Ana A1 Díaz Peromingo, José Antonio A1 Lama López, Adriana A1 Domínguez, María Jesús A1 Rábade Castedo, Carlos A1 Páez Guillán, Emilio Manuel A1 Riveiro Blanco, Vanessa A1 Pernas Pardavila, Hadrián A1 Beceiro, María del Carmen A1 Caruezo Rodríguez, Valentín A1 Naveira Castelo, Alberto A1 Cariñena Amigo, Agustín A1 Cabaleiro Ocampo, Teresa A1 Estany Gestal, Ana A1 Zarra Ferro, Irene A1 Pose Reino, Antonio A1 Valdés Cuadrado, Luis A1 Álvarez Escudero, Julián K1 COVID-19 K1 Dexamethasone K1 Oxygen K1 Treatment Outcome AB 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. Trial registration: ClinicalTrials.gov NCT04726098. PB European Respiratory Society SN 0903-1936 YR 2022 FD 2022-08 LK https://hdl.handle.net/10347/45133 UL https://hdl.handle.net/10347/45133 LA eng NO Taboada, 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/10.1183/13993003.02518-2021 DS Minerva RD 28 abr 2026