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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.

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 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.

SUBMITTER: Taboada M

PROVIDER: S-EPMC8678498 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Effect of high <i>versus</i> low dose of dexamethasone on clinical worsening in patients hospitalised with moderate or severe COVID-19 pneumonia: an open-label, randomised clinical trial.

Taboada Manuel M Rodríguez Nuria N Varela Pablo Manuel PM Rodríguez María Teresa MT Abelleira Romina R González Amara A Casal Ana A Díaz Peromingo José Antonio JA Lama Adriana A Domínguez María Jesús MJ Rábade Carlos C Páez Emilio Manuel EM Riveiro Vanessa V Pernas Hadrián H Beceiro María Del Carmen MDC Caruezo Valentín V Naveira Alberto A Cariñena Agustín A Cabaleiro Teresa T Estany-Gestal Ana A Zarra Irene I Pose Antonio A Valdés Luis L Álvarez-Escudero Julián J

The European respiratory journal 20220804 2

<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 34916266

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