NCT04673162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P25-P50 for phase_3 covid19

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

December 17, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2021

Completed
Last Updated

May 23, 2022

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

December 16, 2020

Last Update Submit

May 20, 2022

Conditions

Covid19

Keywords

Covid19Methylprednisolone

Outcome Measures

Primary Outcomes (1)

  • Length of hospitalization

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

    30 days since randomisation

Study Arms (2)

A SOC plus MP

EXPERIMENTAL

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

Drug: Methylprednisolone, Placebo

B SOC plus Pb

ACTIVE COMPARATOR

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

Drug: Methylprednisolone, Placebo

Interventions

Methylprednisolone, PlaceboDRUG

iv administration

Also known as: Standard treatment
A SOC plus MPB SOC plus Pb

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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-

You may not qualify if:

  • 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-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

UO di Malattie Infettive, Azienda Sociosanitaria Ligure 1

Sanremo, Imperia, 18038, Italy

Location

SOC di Pneumologia, Az. Osp. S. Antonio e Biagio e C. Arrigo

Alessandria, 15121, Italy

Location

UO di Pneumologia, Ospedale San Donato

Arezzo, 52100, Italy

Location

UO di Malattie Infettive, Policlinico Sant'Orsola Malpighi

Bologna, 40138, Italy

Location

UO di Pneumologia e Terapia Intensiva Respiratoria, Policlinico Sant' Orsola Malpighi

Bologna, 40138, Italy

Location

Reparto di Malattie Infettive, Comprensorio Sanitario di Bolzano- Az. Sanitaria Alto Adige

Bolzano, 39100, Italy

Location

SOC di Malattie Infettive, ASST di Cremona

Cremona, 26100, Italy

Location

SOC di Malattie Infettive, AOU Careggi

Florence, 50134, Italy

Location

UOC di Pneumologia, IRCCS Ospedale Policlinico San Martino

Genova, 16132, Italy

Location

SC di Malattie Infettive,Ospedale Sant'Andrea - Az. Sociosanitaria Ligure 5

La Spezia, 19121, Italy

Location

UO Malattie Infettive, Azienda Ospedaliera Universitaria- Policlinico di Modena

Modena, 41124, Italy

Location

UO Clinica Pneumologica - Ospedale "San Gerardo" - ASST di Monza

Monza, 20900, Italy

Location

UO Terapia Anestesia e Rianimazione - Ospedale "San Gerardo" - ASST di Monza

Monza, 20900, Italy

Location

UO di Malattie Infettive, Ospedale Guglielmo da Saliceto - AUSL di Piacenza

Piacenza, 29100, Italy

Location

UO di Pneumologia, Ospedale Guglielmo da Saliceto - AUSL di Piacenza

Piacenza, 29100, Italy

Location

SOC di Malattie Infettive - AUSL-IRCCS di Reggio Emilia

Reggio Emilia, 42123, Italy

Location

SOC di Pneumologia - AUSL-IRCCS di Reggio Emilia

Reggio Emilia, 42123, Italy

Location

SOC di Reumatologia, AUSL- IRCCS di Reggio Emilia

Reggio Emilia, 42123, Italy

Location

UOC di Malattie Infettive - Azienda Unità Locale Socio Sanitaria n. 2

Treviso, 31100, Italy

Location

UO di Pneumologia, Azienda Ospedaliera Universitaria Integrata

Verona, 37126, Italy

Location

Related Publications (1)

  • Salvarani C, Massari M, Costantini M, Merlo DF, Mariani GL, Viale P, Nava S, Guaraldi G, Dolci G, Boni L, Savoldi L, Bruzzi P, Turra C, Catanoso M, Marata AM, Barbieri C, Valcavi A, Franzoni F, Cavuto S, Mazzi G, Corsini R, Trapani F, Bartoloni A, Barisione E, Barbieri C, Burastero GJ, Pan A, Inojosa W, Scala R, Burattini C, Luppi F, Codeluppi M, Tarek KE, Cenderello G, Salio M, Foti G, Dongilli R, Bajocchi G, Negri EA, Ciusa G, Fornaro G, Bassi I, Zammarchi L, Aloe T, Facciolongo N. Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia: a double-blind, randomised, placebo-controlled trial. Eur Respir J. 2022 Oct 20;60(4):2200025. doi: 10.1183/13993003.00025-2022. Print 2022 Oct.

    PMID: 35361632DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Massimo Costantini, MD

    AUSL-IRCCS di Reggio Emilia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Placebo controlled
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, multicentric, double blind
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 17, 2020

Study Start

December 17, 2020

Primary Completion

April 21, 2021

Study Completion

July 12, 2021

Last Updated

May 23, 2022

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
As soon as the main results have been published
Access Criteria
publication reviewers

Locations

IT(20)