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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04673162

Enrollment

260

Registered

2020-12-17

Start date

2020-12-17

Completion date

2021-07-12

Last updated

2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

Covid19, Methylprednisolone

Brief summary

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

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.

Interventions

DRUGMethylprednisolone, Placebo

iv administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Placebo controlled

Intervention model description

Randomized, multicentric, double blind

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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-

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026