Trial IRCT20200204046369N1
Publication Ranjbar K, Research square, 2021 (preprint)
Dates: 2020-08-10 to 2020-11-15
Funding: No specific funding (No specific funding was obtained for this study)
Conflict of interest: No

Methods
RCT
Blinding: triple blinding
Location : Single center / Iran
Follow-up duration (days): 28
Inclusion criteriaHospitalized 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 criteriaPregnancy;
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 ( / )Co-Intervention: Standard care
Duration :
Control
Dexamethasone ( / )
Duration :
Participants
Randomized
93 participants (n1=47 / n2= 46)
Characteristics of participants
N=93
Mean age : 58.7
49 males
Severity : Mild: n=0 / Moderate: n=0/ Severe: n=86 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 stated

Yes
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).