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CompletedNCT04673162Updated May 23, 2022

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

A Phase 3 interventional study of Methylprednisolone, Placebo in Covid19, sponsored by Azienda Unita Sanitaria Locale Reggio Emilia. Completed at 20 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-23.

Sponsored by Azienda Unita Sanitaria Locale Reggio Emilia · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Covid19

Keywords

  • Covid19
  • Methylprednisolone
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 260 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Azienda Unita Sanitaria Locale Reggio Emilia is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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-
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
260 participants (actual)

Study arms

  • 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

  • Active comparator
    B SOC plus Pb

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

    Drug: Methylprednisolone, Placebo

Interventions

  • DrugMethylprednisolone, Placebo

    iv administration

    Also known as: Standard treatment

06

What researchers measure

Primary outcomes

  1. Length of hospitalization

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

    Time frame: 30 days since randomisation

07

Study locations

20 sites
  • UO di Malattie Infettive, Azienda Sociosanitaria Ligure 1
    Sanremo, Imperia 18038, Italy
  • SOC di Pneumologia, Az. Osp. S. Antonio e Biagio e C. Arrigo
    Alessandria, 15121, Italy
  • UO di Pneumologia, Ospedale San Donato
    Arezzo, 52100, Italy
  • UO di Malattie Infettive, Policlinico Sant'Orsola Malpighi
    Bologna, 40138, Italy
  • UO di Pneumologia e Terapia Intensiva Respiratoria, Policlinico Sant' Orsola Malpighi
    Bologna, 40138, Italy
  • Reparto di Malattie Infettive, Comprensorio Sanitario di Bolzano- Az. Sanitaria Alto Adige
    Bolzano, 39100, Italy
  • SOC di Malattie Infettive, ASST di Cremona
    Cremona, 26100, Italy
  • SOC di Malattie Infettive, AOU Careggi
    Firenze, 50134, Italy
  • UOC di Pneumologia, IRCCS Ospedale Policlinico San Martino
    Genova, 16132, Italy
  • SC di Malattie Infettive,Ospedale Sant'Andrea - Az. Sociosanitaria Ligure 5
    La Spezia, 19121, Italy
  • UO Malattie Infettive, Azienda Ospedaliera Universitaria- Policlinico di Modena
    Modena, 41124, Italy
  • UO Clinica Pneumologica - Ospedale "San Gerardo" - ASST di Monza
    Monza, 20900, Italy
  • UO Terapia Anestesia e Rianimazione - Ospedale "San Gerardo" - ASST di Monza
    Monza, 20900, Italy
  • UO di Malattie Infettive, Ospedale Guglielmo da Saliceto - AUSL di Piacenza
    Piacenza, 29100, Italy
  • UO di Pneumologia, Ospedale Guglielmo da Saliceto - AUSL di Piacenza
    Piacenza, 29100, Italy
  • SOC di Malattie Infettive - AUSL-IRCCS di Reggio Emilia
    Reggio Emilia, 42123, Italy
  • SOC di Pneumologia - AUSL-IRCCS di Reggio Emilia
    Reggio Emilia, 42123, Italy
  • SOC di Reumatologia, AUSL- IRCCS di Reggio Emilia
    Reggio Emilia, 42123, Italy
  • UOC di Malattie Infettive - Azienda Unità Locale Socio Sanitaria n. 2
    Treviso, 31100, Italy
  • UO di Pneumologia, Azienda Ospedaliera Universitaria Integrata
    Verona, 37126, Italy
08

References and documents

Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04673162
Lead sponsor
Azienda Unita Sanitaria Locale Reggio Emilia
Responsible party
Sponsor
First posted
Dec 17, 2020
Start date
Dec 17, 2020
Primary completion
Apr 21, 2021
Completion
Jul 12, 2021
Last update
May 23, 2022

Study contacts

Massimo Costantini, MD
study chair · AUSL-IRCCS di Reggio Emilia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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