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=*
Number of vaccinated participants: NR
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
available

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.