Evaluation of Methylprednisolone Administration as a Therapeutic Option in the Coronavirus disease 2019 (COVID-19): A Randomized Controlled Study

The effect of methylprednisolone administration vs. dexamethasone on clinical status of COVID-19 patients based on a 9-points WHO ordinal scale

Clinical trial with control group, with parallel groups, triple-blinded, phase 2-3 on 86 patients. Block Randomization was used for randomization.

This study was performed in Shahid Faghihi Hospital. This clinical trial was performed on 86 patients with COVID-19 in two intervention and control groups. Patients are treated according to the defined protocol and in addition to that, the intervention group received methylprednisolone and the control group received dexamethasone. Packaging containers contain the drug anonymously, so that none of the patients, assesors, and those performing statistical analysis of the study data will be aware of the patient's treatment group.

Hospitalized patients with confirmed COVID-19 will be included in this study if they fulfilled two primary criteria: Hospitalized patients with positive RT-PCR and age >18 years and O2 saturation of less than 92 in room air. Patients will be excluded if they have a known contraindication to treatment with the steroids, pregnant patients, Uncontrolled DM, Uncontrolled hypertension, Immunodeficiency disorders

In addition to the standard care recommended by the National Committee, an initial dose of 2mg/kg will be started for all patients in the case group. The patients will receive the mentioned dose for 5 days, which will then be halved every 5 days. Patients in control group, in addition to the standard care , receive dexamethasone 6 mg daily intravenously.

Primary endpoint: The all-cause mortality in 28 days and Clinical status Secondary endpoint: Intubation and need for ventilation, admission to ICU, and also duration of hospitalization

Corrections were made regarding randomization and the method of conducting the trial.

Random allocation using the block randomization method was performed in all four branches of the strata, based on two prognostic factors such as age (< 55 and ≥55) and disease severity based on O2 Saturation (<85 and ≥85). During random allocation, allocation concealment was noticed. The patient, assessor, and analyzer in the two groups did not have access to the randomization list and type of administered drug (Triple blind)

Packaging containers contain unnamed medicine and there is only one registration number on them in the research center and this number is also available to the treating physicians. Thus, none of the patients, colleagues who are in charge of clinical follow-up and outcome assessment, and those who perform statistical analysis of study data, before the allocation concealment and after the study (blinding), will not know the patient's group therapy.

The study results will be published as an article. The study protocol and statistical analysis used in the article will be considered.

It will be published a year after the study is completed and will be available in the sources.

Information will be made available after permission of the sponsor for academic researchers, physicians, and academic institutions .

Other researchers can use the results of the study in their review and meta-analysis.

Dr Moghadami, Department of Internal Medicine, Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran

upon request, the corresponding author will respond after consulting with the sponsor of the study.