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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Methylprednisolone, Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Alessandria, Italy, 15121
    • SOC di Pneumologia, Az. Osp. S. Antonio e Biagio e C. Arrigo
  • Arezzo, Italy, 52100
    • UO di Pneumologia, Ospedale San Donato
  • Bologna, Italy, 40138
    • UO di Malattie Infettive, Policlinico Sant'Orsola Malpighi
  • Bologna, Italy, 40138
    • UO di Pneumologia e Terapia Intensiva Respiratoria, Policlinico Sant' Orsola Malpighi
  • Bolzano, Italy, 39100
    • Reparto di Malattie Infettive, Comprensorio Sanitario di Bolzano- Az. Sanitaria Alto Adige
  • Cremona, Italy, 26100
    • SOC di Malattie Infettive, ASST di Cremona
  • Firenze, Italy, 50134
    • SOC di Malattie Infettive, AOU Careggi
  • Genova, Italy, 16132
    • UOC di Pneumologia, IRCCS Ospedale Policlinico San Martino
  • La Spezia, Italy, 19121
    • SC di Malattie Infettive,Ospedale Sant'Andrea - Az. Sociosanitaria Ligure 5
  • Modena, Italy, 41124
    • UO Malattie Infettive, Azienda Ospedaliera Universitaria- Policlinico di Modena
  • Monza, Italy, 20900
    • UO Clinica Pneumologica - Ospedale "San Gerardo" - ASST di Monza
  • Monza, Italy, 20900
    • UO Terapia Anestesia e Rianimazione - Ospedale "San Gerardo" - ASST di Monza
  • Piacenza, Italy, 29100
    • UO di Malattie Infettive, Ospedale Guglielmo da Saliceto - AUSL di Piacenza
  • Piacenza, Italy, 29100
    • UO di Pneumologia, Ospedale Guglielmo da Saliceto - AUSL di Piacenza
  • Reggio Emilia, Italy, 42123
    • SOC di Malattie Infettive - AUSL-IRCCS di Reggio Emilia
  • Reggio Emilia, Italy, 42123
    • SOC di Pneumologia - AUSL-IRCCS di Reggio Emilia
  • Reggio Emilia, Italy, 42123
    • SOC di Reumatologia, AUSL- IRCCS di Reggio Emilia
  • Treviso, Italy, 31100
    • UOC di Malattie Infettive - Azienda Unità Locale Socio Sanitaria n. 2
  • Verona, Italy, 37126
    • UO di Pneumologia, Azienda Ospedaliera Universitaria Integrata
  • Imperia
    • Sanremo, Imperia, Italy, 18038
      • UO di Malattie Infettive, Azienda Sociosanitaria Ligure 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia
• Investigators: Study Chair: Massimo Costantini, MD, AUSL-IRCCS di Reggio Emilia

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Actual): April 21, 2021
• Study Completion (Actual): July 12, 2021

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Covid19; Methylprednisolone
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: RCT-MP-COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: As soon as the main results have been published
• IPD Sharing Access Criteria: publication reviewers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No