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Randomized Controlled Trial
. 2021 Apr 15:897:173947.
doi: 10.1016/j.ejphar.2021.173947. Epub 2021 Feb 16.

No clinical benefit of high dose corticosteroid administration in patients with COVID-19: A preliminary report of a randomized clinical trial

Hamidreza Jamaati  1 , Seyed MohammadReza Hashemian  1 , Behrooz Farzanegan  2 , Majid Malekmohammad  2 , Payam Tabarsi  3 , Majid Marjani  3 , Afshin Moniri  4 , Zahra Abtahian  1 , Sara Haseli  1 , Esmaeil Mortaz  5 , Alireza Dastan  6 , Abdolreza Mohamadnia  1 , Abdolbaset Vahedi  1 , Fatemeh Monjazebi  7 , Fatemeh Yassari  1 , Lida Fadaeizadeh  8 , Ali Saffaei  9 , Farzaneh Dastan  10
Affiliations
Randomized Controlled Trial

No clinical benefit of high dose corticosteroid administration in patients with COVID-19: A preliminary report of a randomized clinical trial

Hamidreza Jamaati et al. Eur J Pharmacol. .

Abstract

The aim of this study was to evaluate the clinical effects of dexamethasone administration in patients with mild to moderate acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19). The study included 50 patients who were randomly assigned to the dexamethasone group or control group. Dexamethasone was administered at a dose of 20 mg/day from day 1-5 and then at 10 mg/day from day 6-10. The need for invasive mechanical ventilation, death rate, duration of clinical improvement, length of hospital stay, and radiological changes in the computed tomography scan were assessed. The results revealed that 92% and 96% of patients in the dexamethasone and control groups, respectively, required noninvasive ventilation (P = 0.500). Among them, 52% and 44% of patients in the dexamethasone and control groups, respectively, required invasive mechanical ventilation (P = 0.389). At the end of the study, 64% of patients in the dexamethasone group and 60% of patients in the control group died (P = 0.500); the remaining patients were discharged from the hospital during the 28-day follow-up period. The median length of hospital stay was 11 days in the dexamethasone group and 6 days in the control group (P = 0.036) and the median length of hospital stay was 7 days in the dexamethasone group and 3 days in the control group (P < 0.001). No significant differences were observed in the other outcomes. This study showed that corticosteroid administration had no clinical benefit in patients with COVID-19-induced mild to moderate ARDS.

Keywords: COVID-19; Corticosteroids; Dexamethasone; SARS-Cov-2.

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Conflict of interest statement

None.

Figures

Fig. 1
Fig. 1
(Left side, Dexamethasone group) A 48-year-old man with fever, dyspnea and positive RT-PCR for SARS-CoV-2. Initial non-contrast enhanced CT in axial planes (A and B) shows bilateral ground glass opacities and consolidation in subpleural and peri-bronchovascular locations (*). Repeated CT images (C and D) after dexamethasone administration show decrease in the severity of mentioned parenchymal infiltrations bilaterally (■). (Right side, Control group) A 41-year-old man with fever, dyspnea and positive RT-PCR for SARS-CoV-2. Initial non-contrast enhanced CT in axial planes (A and B) shows bilateral ground glass opacities and consolidation in subpleural and Peri-bronchovascular locations (*). Repeated CT images (C and D) shows decrease in the severity of mentioned parenchymal infiltrations bilaterally.
Fig. 2
Fig. 2
Mean Sequential Organ Failure Assessment scores in both groups stratified according to clinical outcomes.
Fig. 3
Fig. 3
Cumulative incidence of death from baseline to day 28 stratified according to dexamethasone administration. Fall in lines shows the death event and small vertical lines show the improvement event.
See this image and copyright information in PMC

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