Covid-19 living Data

Methylprednisolone vs Dexamethasone (RCT)

Hospitalized patients

Studies included but not extracted/included in the analysis: Salton F, Eur Respir J, 2022; Corral-Gudino L, Eur J Clin Invest, 2022

FOREST PLOTS -2022-08-04

Studies description

Trial IRCT20210223050466N1
Publication Dastenae ZH, Int J Infect Dis (2022) (published paper)
Dates: 2021-04-01 to 2021-06-30
Funding: Public/non profit (Shahrekord University of Medical Sciences)
Conflict of interest: No

Trial IRCT20200204046369N1
Publication Ranjbar K, BMC Infect Dis (2021) (published paper)
Dates: 2020-08-10 to 2020-11-15
Funding: Public/non profit (Research deputy chancellor of Shiraz university of medical sciences)
Conflict of interest: No

Methods
	RCT Blinding: double blinding
	Location : Single center / Iran Follow-up duration (days): 28
Inclusion criteria	Hospitalized patients above 18 years of age SARS-CoV-2 infection confirmed by real-time PCR O2 saturation of less than 92 in room air
Exclusion criteria	Pregnancy Uncontrolled diabetes mellitus (DM) Uncontrolled hypertension Patients who had previously been treated with steroids for any reason, or any contraindications of steroid administration Immunodeficiency disorders O2 saturation of above 92 in room air Lack of willingness to participate in the study
Interventions
	Treatment Methylprednisolone 2 mg/kg IV once daily over 60 minutes for 10 days, tapered to half dosage after 5 days
	Control Dexamethasone 6 mg IV once daily for 10 days
Participants
	Randomized participants : Methylprednisolone=47 Dexamethasone=46
	Characteristics of participants N= 93 Mean age : NR 49 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=* Critical: n=*
Primary outcome
	In the register The all-cause mortality in 28 days and Clinical status
	In the report All-cause mortality in 28 days; Clinical status after 5 and 10 days after enrollment with 9-point WHO ordinal scale
Documents avalaible	Protocol NR Statistical plan NR Data-sharing willing stated in the publication:
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the pre-print article, the trial registry was used in data extraction and risk of bias assessment. Significant changes were made to the trial registration after the end of the study recruitment: it was changed from an unblinded, non-randomized study to a triple blinded, randomized trial; inclusion criteria 'O2 saturation of less than 92 in room air' and 'Hospitalized patients' were added; the methylprednisolone regimen was changed; the comparator was changed from standard care to dexamethasone; the sample size was increased; the primary and secondary outcome measures were changed from PAO2/fio2 (primary) and oxygen saturation, CT scan and clinical follow-up (secondary) to all-cause mortality and clinical status (primary) and mechanical ventilation, ICU admission and length of hospital stay (secondary). On 19th of April, 2021, this study was updated based on the published report. On April 09th, 2021, we received additional information from authors on this study. This study was updated with data from contact with authors on April 19th, 2021.

Methods
	RCT Blinding: single blinding
	Location : Single center / Iran Follow-up duration (days): 28
Inclusion criteria	Age under 80 years Positive RT-PCR test Bilateral lung involvement in high-resolution computed tomography oxygen saturation (SpO2) <93% and the need for supplemental oxygen Providing consent to participate in the study
Exclusion criteria	Discharge from hospital before recovery Death within the first 24 hours Acute myocardial ischemia during the hospital stay Contraindications to corticosteroids because of underlying diseases such as acute hepatitis or fungal infection Lack of volunteering to participate in the study
Interventions
	Treatment Methylprednisolone 60 mg intravenously per day for up to 10 days (2/3 of the dose in the morning and 1/3 in the afternoon)
	Control Dexamethasone 8 mg intravenously per day for up to 10 days (2/3 of the dose in the morning and 1/3 in the afternoon)
Participants
	Randomized participants : Dexamethasone=70 Methylprednisolone=73
	Characteristics of participants N= 143 Mean age : NR 80 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=*
Primary outcome
	In the register Duration of hospitalization [Timepoint: From admission to discharge]
	In the report Duration of hospitalization
Documents avalaible	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Not reported
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the published article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. There is no change from the trial registration in the intervention and control treatments. The primary outcome in the article reflects that in the registry. The trial (n = 143) achieved its target sample size (n = 140). All adverse events were not reported. Baseline severity and oxygen therapies in each group were not well described.