Trial IRCT20200406046963N1
Publication Farahani R, Research Square (2020) (preprint)
Dates: 2020-04-01 to 2020-05-30
Funding: Public/non profit (AJA University of Medical Science)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Single center / Iran
Follow-up duration (days): *
Inclusion criteria
  • Patients 18 years of age or older with moderate to severe Covid-19 infection who admitted to ICU with PaO2/FiO2 less than 300 and progressive disease not responding to recommended treatment with the prediction of need for intubation within next 24 hours
Exclusion criteria
  • Patients with uncontrolled diabetes mellitus, Active GI bleeding, history of corticosteroid hypersensitivity, severe electrolyte imbalances, Procalcitonin more than 0.5, active bacterial, viral (HIV, Hepatitis), and fungal infection
Interventions
Treatment
IVMP Pulse+Pred
Methylprednisolone: 1000 mg IV injection once a day for three days.
Prednisolone: 1 mg/kg orally with tapering of dose within ten days
Control
Standard care

Participants
Randomized
participants :
Standard care=15
IVMP Pulse+Pred=14
Characteristics of participants
N= 29
Mean age : NR
19 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=29 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Mortality rate, blood O2 saturation, and need for further oxygen therapy
In the report
Mortality rate, blood O2 saturation, and need for further oxygen therapy
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
*
General comment This study is pending author reply. Data per arm for the outcomes were not reported.

In addition to the available version of the pre-print, the study registry was used in data extraction and risk of bias assessment. The study did not achieve the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry primary outcomes reflect the reported primary outcomes, however some secondary outcomes from the registry are not reported in the paper (e.g., ICU length of stay). Adverse events are not reported. Other secondary outcomes (e.g., CPK, LDH) are reported in the paper, but not pre-specified in the trial registry.