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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04673162
• Other study ID #: RCT-MP-COVID-19
• Status: Completed
• Phase: Phase 3
• Start date: December 17, 2020
• Est. completion date: July 12, 2021

Study information

• Verified date: December 2020
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: July 12, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Pneumonia

Intervention

Drug:
• Methylprednisolone, Placebo
iv administration

Locations

Country	Name	City	State
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	Firenze
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	UO di Malattie Infettive, Azienda Sociosanitaria Ligure 1	Sanremo	Imperia
Italy	UOC di Malattie Infettive - Azienda Unità Locale Socio Sanitaria n. 2	Treviso
Italy	UO di Pneumologia, Azienda Ospedaliera Universitaria Integrata	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospitalization	the interval between randomization and discharge from the hospital without the need for supplemental oxygen	30 days since randomisation