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

Phase 3

Completed

• Conditions: Covid19
• Interventions: Drug: Methylprednisolone, Placebo

• Registration Number: NCT04673162
• Lead Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia

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.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-16
• Study Start: 2020-12-17
• Study First Posted: 2020-12-17
• Primary Completion: 2021-04-21
• Study Completion: 2021-07-12
• Last Update Submitted: 2022-05-20
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A SOC plus MP	Methylprednisolone, Placebo	Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Methylprednisolone 1gr daily iv on days 1,2,3
B SOC plus Pb	Methylprednisolone, Placebo	Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Placebo

Primary Outcome Measures

Name	Time	Method
Length of hospitalization	30 days since randomisation	the interval between randomization and discharge from the hospital without the need for supplemental oxygen

Trial Locations

Locations (20)

UO di Malattie Infettive, Azienda Sociosanitaria Ligure 1; 🇮🇹 Sanremo, Imperia, Italy

UO di Pneumologia, Ospedale Guglielmo da Saliceto - AUSL di Piacenza; 🇮🇹 Piacenza, Italy

SOC di Pneumologia - 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

UO di Pneumologia, Ospedale San Donato; 🇮🇹 Arezzo, Italy

SOC di Malattie Infettive, ASST di Cremona; 🇮🇹 Cremona, Italy

UO Malattie Infettive, Azienda Ospedaliera Universitaria- Policlinico di Modena; 🇮🇹 Modena, Italy

UO Terapia Anestesia e Rianimazione - Ospedale "San Gerardo" - ASST di Monza; 🇮🇹 Monza, Italy

SOC di Malattie Infettive, AOU Careggi; 🇮🇹 Firenze, Italy

SOC di Malattie Infettive - AUSL-IRCCS di Reggio Emilia; 🇮🇹 Reggio Emilia, Italy

UO di Malattie Infettive, Policlinico Sant'Orsola Malpighi; 🇮🇹 Bologna, Italy

UO Clinica Pneumologica - Ospedale "San Gerardo" - ASST di Monza; 🇮🇹 Monza, Italy

UOC di Pneumologia, IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy

SOC di Reumatologia, AUSL- IRCCS di Reggio Emilia; 🇮🇹 Reggio Emilia, Italy

SOC di Pneumologia, Az. Osp. S. Antonio e Biagio e C. Arrigo; 🇮🇹 Alessandria, Italy

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

SC di Malattie Infettive,Ospedale Sant'Andrea - Az. Sociosanitaria Ligure 5; 🇮🇹 La Spezia, Italy