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Randomized Controlled Trial
. 2024 Nov 11;24(1):562.
doi: 10.1186/s12890-024-03364-4.

A comparative study between methylprednisolone versus dexamethasone as an initial anti-inflammatory treatment of moderate COVID-19 pneumonia: an open-label randomized controlled trial

Jakkrit Laikitmongkhon  1 , Tanapat Tassaneyasin  2 , Yuda Sutherasan  3 , Angsana Phuphuakrat  4 , Sirawat Srichatrapimuk  2 , Tananchai Petnak  1 , Dararat Eksombatchai  1 , Kanin Thammavaranucupt  2 , Somnuek Sungkanuparph  2
Affiliations
Randomized Controlled Trial

A comparative study between methylprednisolone versus dexamethasone as an initial anti-inflammatory treatment of moderate COVID-19 pneumonia: an open-label randomized controlled trial

Jakkrit Laikitmongkhon et al. BMC Pulm Med. .

Abstract

Background: The most appropriate anti-inflammatory treatment for moderate COVID-19 pneumonia remains uncertain. We aimed to compare the effectiveness of a high-dose methylprednisolone versus a high-dose dexamethasone in hospitalized moderate COVID-19 pneumonia, regarding the WHO clinical progression scales, mortality, and the length of hospitalization.

Methods: In this open-labeled randomized controlled trial, we enrolled patients with age > 18 years old who were diagnosed moderate COVID-19 pneumonia confirmed by real-time PCR, evidence of pneumonia by chest imaging and resting oxygen saturation between 90 and 94%. Patients were randomized at a 1:1 ratio to receive methylprednisolone 250 mg/day or dexamethasone 20 mg/day over the first three days. Then the patients in both groups received dexamethasone 20 mg/day on days 4-5, and 10 mg/day on days 6-10. Primary outcome was assessed by a 10-point WHO clinical progression scales ranging from uninfected (point 0) to death (point 10) on the fifth day of treatment. Secondary outcomes including 90-day mortality, length of hospitalization, rate of intensive care unit (ICU) transfer and complications were determined.

Results: Of 98 eligible patients, the mean age was 76.0 ± 13.3 years. The median date of illness at the time of randomization was 3 days (interquartile range 2, 5). Baseline clinical characteristics and severity did not differ between groups. The WHO clinical progression scales were similar between methylprednisolone and dexamethasone group at 5 and 10 days of treatment [4.84, (95% confidence interval(CI), 4.35-5.33) vs. 4.76 (95% CI, 4.27-5.25), p = 0.821 and 4.32 (95% CI, 3.83-4.81) vs. 3.80 (95% CI, 3.31-4.29), p = 0.140, respectively)]. Both groups did not differ in-hospital mortality, length of hospitalization, and rate of ICU transfer. There were also no differences in steroid-related complications between groups until 90 days of follow-up.

Conclusions: In patients with moderate COVID-19 pneumonia, initial anti-inflammatory treatment with 250 mg/day of methylprednisolone for three days does not yield better outcomes over high-dose dexamethasone.

Trial registration: This study was registered at Thai Clinical Trials Registry on October 17, 2021, with the identifier TCTR20211017001.

Keywords: COVID-19; Corticosteroids; Moderate pneumonia; Randomized controlled trial.

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Conflict of interest statement

Declarations Ethics approval and consent to participate This study was approved by the Human Research Ethics Committee, Faculty of Medicine, Ramathibodi Hospital, Mahidol University on October 11, 2021 (code COA.MURA2021/855) and registered at Thai Clinical Trials Registry on October 17, 2021, with identifier TCTR20211017001. Every patient is provided with informed consent. Consent for publication Not applicable. Competing interests The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
The Consolidated Standards of Reporting trials flow diagram of the study
Fig. 2
Fig. 2
Diagram of the mean (95% confidence interval) of WHO clinical progression scales at day 1, day 5, and day 10 in the MP group and DXM group and p-value by multilevel mixed-effects linear regression. Data are presented as mean (95% confidence interval or 95%CI) and p-value. MP: methylprednisolone; DXM: dexamethasone
See this image and copyright information in PMC

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