Clinical trial NCT04673162: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Keywords: Covid19
Methylprednisolone
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2020-12-17
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, multicentric, double blind
Primary purpose: TREATMENT

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.

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-

Primary outcomes:
measure: Length of hospitalization
timeFrame: 30 days since randomisation
Secondary outcomes:
Other outcomes:
Locations:
city: Sanremo
country: Italy
facility: UO di Malattie Infettive, Azienda Sociosanitaria Ligure 1
state: Imperia
city: Alessandria
country: Italy
facility: SOC di Pneumologia, Az. Osp. S. Antonio e Biagio e C. Arrigo
city: Arezzo
country: Italy
facility: UO di Pneumologia, Ospedale San Donato
city: Bologna
country: Italy
facility: UO di Malattie Infettive, Policlinico Sant'Orsola Malpighi
city: Bologna
country: Italy
facility: UO di Pneumologia e Terapia Intensiva Respiratoria, Policlinico Sant' Orsola Malpighi
city: Bolzano
country: Italy
facility: Reparto di Malattie Infettive, Comprensorio Sanitario di Bolzano- Az. Sanitaria Alto Adige
city: Cremona
country: Italy
facility: SOC di Malattie Infettive, ASST di Cremona
city: Firenze
country: Italy
facility: SOC di Malattie Infettive, AOU Careggi
city: Genova
country: Italy
facility: UOC di Pneumologia, IRCCS Ospedale Policlinico San Martino
city: La Spezia
country: Italy
facility: SC di Malattie Infettive,Ospedale Sant'Andrea - Az. Sociosanitaria Ligure 5
city: Modena
country: Italy
facility: UO Malattie Infettive, Azienda Ospedaliera Universitaria- Policlinico di Modena
city: Monza
country: Italy
facility: UO Clinica Pneumologica - Ospedale "San Gerardo" - ASST di Monza
city: Monza
country: Italy
facility: UO Terapia Anestesia e Rianimazione - Ospedale "San Gerardo" - ASST di Monza
city: Piacenza
country: Italy
facility: UO di Malattie Infettive, Ospedale Guglielmo da Saliceto - AUSL di Piacenza
city: Piacenza
country: Italy
facility: UO di Pneumologia, Ospedale Guglielmo da Saliceto - AUSL di Piacenza
city: Reggio Emilia
country: Italy
facility: SOC di Malattie Infettive - AUSL-IRCCS di Reggio Emilia
city: Reggio Emilia
country: Italy
facility: SOC di Pneumologia - AUSL-IRCCS di Reggio Emilia
city: Reggio Emilia
country: Italy
facility: SOC di Reumatologia, AUSL- IRCCS di Reggio Emilia
city: Treviso
country: Italy
facility: UOC di Malattie Infettive - Azienda Unità Locale Socio Sanitaria n. 2
city: Verona
country: Italy
facility: UO di Pneumologia, Azienda Ospedaliera Universitaria Integrata
Study officials:
affiliation: AUSL-IRCCS di Reggio Emilia
name: Massimo Costantini, MD
role: STUDY_CHAIR
References: