COVID-19 MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: Metilprednisolone
Product Code: [Metilprednisolone]
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
INN or Proposed INN: METILPREDNISOLONE SODIO SUCCINATO
CAS
Sponsors
AZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. age = 18 years; 2. Informed consent for participation in the study and for data processing; 3. Molecular diagnosis with Polymerase Chain Reaction (PCR) test of Sars-CoV2 infection; 4. Hospitalization in a specialist ward for Covid-19 patient care (eg., Infectious Diseases, Pulmonology or Internal Medicine); 5. Need for supplemental oxygen in any delivery mode with the exception of invasive mechanical ventilation; 6. PaO2 / FiO2 between 100 and 300 mmHg. 7. Clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray or lung ultrasound) of interstitial pneumonia for no more than three days; 8. Serum CRP greater than 5 mg / dL; 9. Interval from onset of SARS-CoV2 infection symptoms to randomization> 5 days Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: 1. Invasive mechanical ventilation; 2. Presence of shock or concomitant organ failure that requires admission to the Intensive Care Unit; 3. Pregnancy or breastfeeding; 4. Severe heart or kidney failure; 5. Known hypersensitivity to methylprednisolone, to dexamethasone or to an exception; 6. Diabetes not compensated according to the doctor's judgment; 7. Other clinical conditions that contraindicate Methylprednisolone and cannot be treated or resolved according to the doctor's judgment; 8. Steroid bolus therapy in the week prior to enrollment for the study; 9. Enrollment in another clinical trial; 10. Patient already randomized in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evualuate the efficacy of the injection of three boluses of Methylprednisolone (1 gr/die for three days), in addition to standard therapy in patients with COVID-19 pneumonia in terms of time to discharge from the hospital;Secondary Objective: Evaluation of the effectiveness of three boluses of methylprednisolone (1 g / day for three days), in addition to standard therapy in patients with COVID-19 pneumonia in terms of: a. prevention of invasive ventilation with oro-tracheal intubation b. survival for all causes Safety assessment throughout the study period;Primary end point(s): Lenght of hospitalization, calculated as the interval between randomization and discharge from the hospital without the need for supplemental oxygen;Timepoint(s) of evaluation of this end point: 30 days since randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Invasive ventilation-free survival with orotracheal intubation; Overall survival, defined as the time between randomisation and death for any cause;Timepoint(s) of evaluation of this end point: 30 days since randomisation; 30 days since randomisation | — |
Countries
Italy
Contacts
Public ContactMassimo Costantini
Azienda USL-IRCCS di Reggio Emilia
Outcome results
None listed