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

Azienda Unità Sanitaria Locale Reggio Emilia

Status and phase: Completed; Phase 3

Conditions: Covid19

Treatments: Drug: Methylprednisolone, Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04673162

RCT-MP-COVID-19

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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-

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-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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260 participants in 2 patient groups

A SOC plus MP

Experimental group

Description:

Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Methylprednisolone 1gr daily iv on days 1,2,3

Treatment:

Drug: Methylprednisolone, Placebo

B SOC plus Pb

Active Comparator group

Description:

Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Placebo

Treatment:

Drug: Methylprednisolone, Placebo