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
Intravenous Methylprednisolone pulse+Prednisolone 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 Definition of Standard care: Recommended regimen (Kaletra [lopinavir/ritonavir] daily, Hydroxychloroquine 400 mg daily, Azithromycin 500 mg daily) | |
Participants | |
Randomized 29 participants (n1=14 / n2= 15) | |
Characteristics of participants N=29 Mean age : 64 19 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=29 Critical: n=0 | |
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 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 |
* |
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. |