Status:
COMPLETED
Evaluation of the Efficacy of High Doses of Methylprednisolone in SARS-CoV2 ( COVID-19) Pneumonia Patients
Lead Sponsor:
Azienda USL Reggio Emilia - IRCCS
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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, requirin...
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 incl...
Eligibility Criteria
Inclusion
- age = 18 years;
- Informed consent for participation in the study and for data processing;
- Molecular diagnosis with Polymerase Chain Reaction (PCR) test of Sars-CoV2 infection;
- Hospitalization in a specialist ward for Covid-19 patient care (eg., Infectious Diseases, Pulmonology or Internal Medicine);
- Need for supplemental oxygen in any delivery mode with the exception of invasive mechanical ventilation;
- PaO2 / FiO2 between 100 and 300 mmHg.
- Clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray or lung ultrasound) of interstitial pneumonia for no more than three days;
- Serum CRP greater than 5 mg / dL;
- Interval from onset of SARS-CoV2 infection symptoms to randomization\> 5 days-
Exclusion
- Invasive mechanical ventilation;
- Presence of shock or concomitant organ failure that requires admission to the Intensive Care Unit;
- Pregnancy or breastfeeding;
- Severe heart or kidney failure;
- Known hypersensitivity to methylprednisolone, to dexamethasone or to an exception;
- Diabetes not compensated according to the doctor's judgment;
- Other clinical conditions that contraindicate Methylprednisolone and cannot be treated or resolved according to the doctor's judgment;
- Steroid bolus therapy in the week prior to enrollment for the study;
- Enrollment in another clinical trial;
- Patient already randomized in this study-
Key Trial Info
Start Date :
December 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2021
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04673162
Start Date
December 17 2020
End Date
July 12 2021
Last Update
May 23 2022
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
UO di Malattie Infettive, Azienda Sociosanitaria Ligure 1
Sanremo, Imperia, Italy, 18038
2
SOC di Pneumologia, Az. Osp. S. Antonio e Biagio e C. Arrigo
Alessandria, Italy, 15121
3
UO di Pneumologia, Ospedale San Donato
Arezzo, Italy, 52100
4
UO di Malattie Infettive, Policlinico Sant'Orsola Malpighi
Bologna, Italy, 40138