evaluation of efficacy and safety of low dose Corticosteroid with severe Pneumonia covid-19

Evaluation of the effect of corticosteroid use in improving patients with COVID-19

Clinical trials have two intervention and control groups, with parallel, one-way, blind, randomized, phase 3 groups on 60 patients. The randomization table was used for randomization.

Both groups received resuscitation 6 weeks after discharge (MMRC) requiring re-hospitalization in the past 6 weeks, as well as The rate of improvement of the CT scan is compared to the initial CT scan, which is both read and scored by a radiologist. Be. Thus, in this study, short-term outcome during hospitalization and long-term outcome after 6 weeks in patients who We will review the lowdose corticosteroids.

Covid-19 patients over 18 years of age, definitive case based on RT-PCR +, at least 7 days have passed since the onset of symptoms, at least 5 days of antiviral treatment, O2SAT <93

In patients admitted to the study with severe hypoxia due to severe pneumonia due to COVID-19 and inclusion criteria, information including vital signs, level of dyspnea (based on Visual Analogue Scale), Sao2 oxygen requirement, demographic characteristics, tests including , CBC, CRP, PCT Imaging The patient including CXR or CT scan is collected through a checklist, then patients are randomly divided into two groups. In both groups, conventional and standard treatments are performed in the same way. The experimental group was treated with methylprednisolone succinate 1-1.75 mg / kg per day and after 5 days, according to the criteria in the questionnaire, the outcome of the disease was evaluated and it was decided whether to continue treatment or discontinue it. The control group did not receive corticosteroids and only received routine treatment.

Radiological changes

Method of randomization: simple Unit of randomization : individual Tools used in randomization : table of random numbers Included patients, in a simple randomized evaluation using even and odd numbers, would got codes for each treatment group. In case of odd numbers, the patient would be enrolled in the group one to receive high flow oxygenation at the first stage and following a washout period, take noninvasive ventilation. On the other hand, patients gotten even numbers would receive noninvasive ventilation for the first stage. Then, after a washout period, high oxygen therapy would be prescribed.

The examining physician will not know the type of intervention. Therefore, the study will be performed blindly.

Clinical trial data will be published as an article

Start access 6 months after printing results

Researchers working in academic and scientific institutions

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Provide the initial file of the approved research plan