COVID-19. Covid-19
Conditions
Interventions
Intervention 1: Intervention group: At Day 1: Amp. Methylprednisolone 500mg IV infusion over 1 hour. At Day 2 and 3, Amp. Methylprednisolone 250mg IV infusion over 1 hour. At Day 4 and 5, Amp. Methylp
Sponsors
Bagheiat-allah University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation. The patient has written consciously and freely consent to participate in the study; The patient has moderate to severe Corona-Virus associated pneumonia; In the first 48 hours of hospitalization, the patient did not show an improving trend; In the first 48 hours after his/her inclusion into this study, there is no possibility of discharge from the patient's hospital;
Exclusion criteria
Exclusion criteria: History of hypersensitivity reaction to glucocorticoids; Recent hospitalization and treatment history due to COVID-19; Receive antiviral drugs before including into this study, such as: Hydroxychloroquine, Kaletra, Ribavirin, Oseltamivir; Receiving Methylprednisolone pulse before including into this study; Uncontrolled severe chronic illnesses, including heart failure, kidney failure, liver failure, active cancer (history of chemotherapy within recent month), diabetes; Receiving immunosuppressing /immunomodulating agents, such as systemic glucocorticoids. Pregnancy; Lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Need to receive ICU service (occurrence of shock, resistant hypoxemia despite receiving oxygen via reservoir oxygen mask, GCS score drops below 12). Timepoint: The patient is monitored every 6 hours, but the results are recorded daily in the checklist. Method of measurement: Physical assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality rate. Timepoint: 30 days after including the study. Method of measurement: Physical assessment.;Length of hospitalization. Timepoint: The first day and the end of hospitalization. Method of measurement: The hospital record review.;Radiologic response. Timepoint: At the admission, before the discharge. Method of measurement: CT-SCAN.;Laboratory changes. Timepoint: Daily. Method of measurement: Blood sample, laboratory analysis.;Fever. Timepoint: Daily. Method of measurement: Thermometer.;Respiratory distress. Timepoint: Daily. Method of measurement: Clinical assessment.;Oxygen saturation without receiving oxygen supplement. Timepoint: It will be measured every 6 hours, but will be recorded daily. Method of measurement: Pulse-oxymetery device.;The amount of oxygen received. Timepoint: It will be measured every 6 hours, but will be recorded daily. Method of measurement: The volume of oxygen consumed through the oxygen mask /Ventilation Volume via Mechanical Ventilation Machine or BiPAP.;Discharge without the need of ICU service. Timepoint: At discharge time. Method of measurement: Physical assessment.;Pulmonary function changes. Timepoint: 6 week later after discharge. Method of measurement: Spirometry.;Rate of readmission. Timepoint: until 2 months after discharge. Method of measurement: The hospital record review.;Side effects. Timepoint: Daily during hospitalization, weekly after discharge. Method of measurement: During hospitalization by clinical evaluation, after discharge by telephone follow-up. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAhmad Zarei
Bagheiat-allah University of Medical Sciences
Outcome results
None listed