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 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 ( / )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). |