Evaluation of the Efficacy of High Doses of Methylprednisolone in SARS-CoV2 ( COVID-19) Pneumonia Patients

Study Overview
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Brief Summary
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This double blind, randomized study is aiming to evaluate the efficacy of three doses (1gr/day) of methylpredisolone added to standard therapy in patients, with documented COVID-19 pneumonia, requiring hospitalization but not mechanical ventilation.

Detailed Description
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Patients recently hospitalized for the treatment of documented COVID-19 pneumonia who do not require invasive ventilation will be randomized (1:1) to receive current standard treatment, which may include desamethasone and oxygen, with methylprenisolone 1gr daily iv for 3 consecutive days or standard treatment alone. Efficacy measures will be time to recovery (discharge from hospital), invasive ventilation prevention and survival. Patients safety will be evaluated throughout the all study period.

Official Title
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A Randomized, Multicentre, Double-blind Study to Evaluate the Efficacy of High-dose Administration of Methylprednisolone in Addition to Standard Treatment, in SARS-CoV2 (COVID-19) Pneumonia Patients

Conditions
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Covid19

Intervention / Treatment
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* Drug: Methylprednisolone, Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age = 18 years; Informed consent for participation in the study and for data processing; Molecular diagnosis with Polymerase Chain Reaction (PCR) test of Sars-CoV2 infection; Hospitalization in a specialist ward for Covid-19 patient care (eg., Infectious Diseases, Pulmonology or Internal Medicine); Need for supplemental oxygen in any delivery mode with the exception of invasive mechanical ventilation; PaO2 / FiO2 between 100 and 300 mmHg. Clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray or lung ultrasound) of interstitial pneumonia for no more than three days; Serum CRP greater than 5 mg / dL; Interval from onset of SARS-CoV2 infection symptoms to randomization> 5 days- Exclusion Criteria: Invasive mechanical ventilation; Presence of shock or concomitant organ failure that requires admission to the Intensive Care Unit; Pregnancy or breastfeeding; Severe heart or kidney failure; Known hypersensitivity to methylprednisolone, to dexamethasone or to an exception; Diabetes not compensated according to the doctor's judgment; Other clinical conditions that contraindicate Methylprednisolone and cannot be treated or resolved according to the doctor's judgment; Steroid bolus therapy in the week prior to enrollment for the study; Enrollment in another clinical trial; Patient already randomized in this study-

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, multicentric, double blind
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A SOC plus MP<br>Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Methylprednisolone 1gr daily iv on days 1,2,3 | Drug: Methylprednisolone, Placebo<br>* iv administration<br>* Other names: Standard treatment;|
| Active Comparator: B SOC plus Pb<br>Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Placebo | Drug: Methylprednisolone, Placebo<br>* iv administration<br>* Other names: Standard treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospitalization | the interval between randomization and discharge from the hospital without the need for supplemental oxygen | 30 days since randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid19, Methylprednisolone