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

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=*
Number of vaccinated participants: NR
Primary outcome
In the register
Duration of hospitalization [Timepoint: From admission to discharge]
In the report
Duration of hospitalization
Documents
available

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.