Skip to main content
OpenTrials
Completed

NCT Number: NCT04673162

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UO di Malattie Infettive, Azienda Sociosanitaria Ligure 1, Sanremo, Imperia, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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-

Treatment and study plan

Methylprednisolone, Placebo

Drug

iv administration

Other names: Standard treatment

Primary outcomes

  1. Length of hospitalization

    Time frame: 30 days since randomisation

    the interval between randomization and discharge from the hospital without the need for supplemental oxygen

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2020
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.