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

NCT ID: NCT04673162

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-17
• Study Completion Date: 2021-07-12

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A SOC plus MP

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

Group Type: EXPERIMENTAL

Methylprednisolone, Placebo

Intervention Type: DRUG

iv administration

B SOC plus Pb

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

Group Type: ACTIVE_COMPARATOR

Methylprednisolone, Placebo

Intervention Type: DRUG

iv administration

Interventions

Methylprednisolone, Placebo

iv administration

Intervention Type: DRUG

Other Intervention Names

Standard treatment

Eligibility Criteria

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-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Massimo Costantini, MD

Role: STUDY_CHAIR

AUSL-IRCCS di Reggio Emilia

Locations

UO di Malattie Infettive, Azienda Sociosanitaria Ligure 1

Sanremo, Imperia, Italy

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

Alessandria, , Italy

UO di Pneumologia, Ospedale San Donato

Arezzo, , Italy

UO di Malattie Infettive, Policlinico Sant'Orsola Malpighi

Bologna, , Italy

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

Bologna, , Italy

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

Bolzano, , Italy

SOC di Malattie Infettive, ASST di Cremona

Cremona, , Italy

SOC di Malattie Infettive, AOU Careggi

Florence, , Italy

UOC di Pneumologia, IRCCS Ospedale Policlinico San Martino

Genova, , Italy

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

La Spezia, , Italy

UO Malattie Infettive, Azienda Ospedaliera Universitaria- Policlinico di Modena

Modena, , Italy

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

Monza, , Italy

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

Monza, , Italy

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

Piacenza, , Italy

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

Piacenza, , Italy

SOC di Malattie Infettive - AUSL-IRCCS di Reggio Emilia

Reggio Emilia, , Italy

SOC di Pneumologia - AUSL-IRCCS di Reggio Emilia

Reggio Emilia, , Italy

SOC di Reumatologia, AUSL- IRCCS di Reggio Emilia

Reggio Emilia, , Italy

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

Treviso, , Italy

UO di Pneumologia, Azienda Ospedaliera Universitaria Integrata

Verona, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 35361632 (View on PubMed)

Other Identifiers

RCT-MP-COVID-19

Identifier Type: -

Identifier Source: org_study_id