Evaluation of the efficacy of high doses of methylprednisolone in SARS-CoV2 pneumonia patients.
- Conditions
- COVID-19MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-004323-16-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 260
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>a. prevention of invasive ventilation with oro-tracheal intubation<br>b. survival for all causes<br>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 Outcome Measures
Name Time Method 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