Trial IRCT20200204046369N1
Publication Ranjbar K, BMC Infect Dis, 2021 (published paper)
Dates: 2020-08-10 to 2020-11-15
Funding: No specific funding (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 ( / ) | |
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=* 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 available |
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).
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. |