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

Last updated: May 20, 2022
Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia
Overall Status: Completed

Phase

3

Condition

Pneumonia

Covid-19

Treatment

N/A

Clinical Study ID

NCT04673162
RCT-MP-COVID-19
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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., InfectiousDiseases, Pulmonology or Internal Medicine);
  5. Need for supplemental oxygen in any delivery mode with the exception of invasivemechanical ventilation;
  6. PaO2 / FiO2 between 100 and 300 mmHg.
  7. Clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray orlung 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

Exclusion Criteria:

  1. Invasive mechanical ventilation;
  2. Presence of shock or concomitant organ failure that requires admission to theIntensive 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 treatedor 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 Design

Total Participants: 260
Study Start date:
December 17, 2020
Estimated Completion Date:
July 12, 2021

Study 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.

Connect with a study center

  • UO di Malattie Infettive, Azienda Sociosanitaria Ligure 1

    Sanremo, Imperia 18038
    Italy

    Site Not Available

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

    Alessandria, 15121
    Italy

    Site Not Available

  • UO di Pneumologia, Ospedale San Donato

    Arezzo, 52100
    Italy

    Site Not Available

  • UO di Malattie Infettive, Policlinico Sant'Orsola Malpighi

    Bologna, 40138
    Italy

    Site Not Available

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

    Bologna, 40138
    Italy

    Site Not Available

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

    Bolzano, 39100
    Italy

    Site Not Available

  • SOC di Malattie Infettive, ASST di Cremona

    Cremona, 26100
    Italy

    Site Not Available

  • SOC di Malattie Infettive, AOU Careggi

    Firenze, 50134
    Italy

    Site Not Available

  • UOC di Pneumologia, IRCCS Ospedale Policlinico San Martino

    Genova, 16132
    Italy

    Site Not Available

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

    La Spezia, 19121
    Italy

    Site Not Available

  • UO Malattie Infettive, Azienda Ospedaliera Universitaria- Policlinico di Modena

    Modena, 41124
    Italy

    Site Not Available

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

    Monza, 20900
    Italy

    Site Not Available

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

    Monza, 20900
    Italy

    Site Not Available

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

    Piacenza, 29100
    Italy

    Site Not Available

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

    Piacenza, 29100
    Italy

    Site Not Available

  • SOC di Malattie Infettive - AUSL-IRCCS di Reggio Emilia

    Reggio Emilia, 42123
    Italy

    Site Not Available

  • SOC di Pneumologia - AUSL-IRCCS di Reggio Emilia

    Reggio Emilia, 42123
    Italy

    Site Not Available

  • SOC di Reumatologia, AUSL- IRCCS di Reggio Emilia

    Reggio Emilia, 42123
    Italy

    Site Not Available

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

    Treviso, 31100
    Italy

    Site Not Available

  • UO di Pneumologia, Azienda Ospedaliera Universitaria Integrata

    Verona, 37126
    Italy

    Site Not Available

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