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

Primary Purpose

Covid19

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Methylprednisolone, Placebo
Sponsored by
Azienda Unità Sanitaria Locale Reggio Emilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Covid19, Methylprednisolone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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-

Sites / Locations

  • UO di Malattie Infettive, Azienda Sociosanitaria Ligure 1
  • SOC di Pneumologia, Az. Osp. S. Antonio e Biagio e C. Arrigo
  • UO di Pneumologia, Ospedale San Donato
  • UO di Malattie Infettive, Policlinico Sant'Orsola Malpighi
  • UO di Pneumologia e Terapia Intensiva Respiratoria, Policlinico Sant' Orsola Malpighi
  • Reparto di Malattie Infettive, Comprensorio Sanitario di Bolzano- Az. Sanitaria Alto Adige
  • SOC di Malattie Infettive, ASST di Cremona
  • SOC di Malattie Infettive, AOU Careggi
  • UOC di Pneumologia, IRCCS Ospedale Policlinico San Martino
  • SC di Malattie Infettive,Ospedale Sant'Andrea - Az. Sociosanitaria Ligure 5
  • UO Malattie Infettive, Azienda Ospedaliera Universitaria- Policlinico di Modena
  • UO Clinica Pneumologica - Ospedale "San Gerardo" - ASST di Monza
  • UO Terapia Anestesia e Rianimazione - Ospedale "San Gerardo" - ASST di Monza
  • UO di Malattie Infettive, Ospedale Guglielmo da Saliceto - AUSL di Piacenza
  • UO di Pneumologia, Ospedale Guglielmo da Saliceto - AUSL di Piacenza
  • SOC di Malattie Infettive - AUSL-IRCCS di Reggio Emilia
  • SOC di Pneumologia - AUSL-IRCCS di Reggio Emilia
  • SOC di Reumatologia, AUSL- IRCCS di Reggio Emilia
  • UOC di Malattie Infettive - Azienda Unità Locale Socio Sanitaria n. 2
  • UO di Pneumologia, Azienda Ospedaliera Universitaria Integrata

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A SOC plus MP

B SOC plus Pb

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 16, 2020
Last Updated
May 20, 2022
Sponsor
Azienda Unità Sanitaria Locale Reggio Emilia
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1. Study Identification

Unique Protocol Identification Number
NCT04673162
Brief Title
Evaluation of the Efficacy of High Doses of Methylprednisolone in SARS-CoV2 ( COVID-19) Pneumonia Patients
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
April 21, 2021 (Actual)
Study Completion Date
July 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Unità Sanitaria Locale Reggio Emilia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Covid19, Methylprednisolone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, multicentric, double blind
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Placebo controlled
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A SOC plus MP
Arm Type
Experimental
Arm Description
Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Methylprednisolone 1gr daily iv on days 1,2,3
Arm Title
B SOC plus Pb
Arm Type
Active Comparator
Arm Description
Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Placebo
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone, Placebo
Other Intervention Name(s)
Standard treatment
Intervention Description
iv administration
Primary Outcome Measure Information:
Title
Length of hospitalization
Description
the interval between randomization and discharge from the hospital without the need for supplemental oxygen
Time Frame
30 days since randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Costantini, MD
Organizational Affiliation
AUSL-IRCCS di Reggio Emilia
Official's Role
Study Chair
Facility Information:
Facility Name
UO di Malattie Infettive, Azienda Sociosanitaria Ligure 1
City
Sanremo
State/Province
Imperia
ZIP/Postal Code
18038
Country
Italy
Facility Name
SOC di Pneumologia, Az. Osp. S. Antonio e Biagio e C. Arrigo
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Facility Name
UO di Pneumologia, Ospedale San Donato
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
UO di Malattie Infettive, Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
UO di Pneumologia e Terapia Intensiva Respiratoria, Policlinico Sant' Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Reparto di Malattie Infettive, Comprensorio Sanitario di Bolzano- Az. Sanitaria Alto Adige
City
Bolzano
ZIP/Postal Code
39100
Country
Italy
Facility Name
SOC di Malattie Infettive, ASST di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
SOC di Malattie Infettive, AOU Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
UOC di Pneumologia, IRCCS Ospedale Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
SC di Malattie Infettive,Ospedale Sant'Andrea - Az. Sociosanitaria Ligure 5
City
La Spezia
ZIP/Postal Code
19121
Country
Italy
Facility Name
UO Malattie Infettive, Azienda Ospedaliera Universitaria- Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
UO Clinica Pneumologica - Ospedale "San Gerardo" - ASST di Monza
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
UO Terapia Anestesia e Rianimazione - Ospedale "San Gerardo" - ASST di Monza
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
UO di Malattie Infettive, Ospedale Guglielmo da Saliceto - AUSL di Piacenza
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Facility Name
UO di Pneumologia, Ospedale Guglielmo da Saliceto - AUSL di Piacenza
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Facility Name
SOC di Malattie Infettive - AUSL-IRCCS di Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
SOC di Pneumologia - AUSL-IRCCS di Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
SOC di Reumatologia, AUSL- IRCCS di Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
UOC di Malattie Infettive - Azienda Unità Locale Socio Sanitaria n. 2
City
Treviso
ZIP/Postal Code
31100
Country
Italy
Facility Name
UO di Pneumologia, Azienda Ospedaliera Universitaria Integrata
City
Verona
ZIP/Postal Code
37126
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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