A Phase 3 interventional study of Methylprednisolone, Placebo in Covid19, sponsored by Azienda Unita Sanitaria Locale Reggio Emilia. Completed at 20 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-23.
Sponsored by Azienda Unita Sanitaria Locale Reggio Emilia · Phase 3, Interventional, and Treatment
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 260 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Azienda Unita Sanitaria Locale Reggio Emilia is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Methylprednisolone 1gr daily iv on days 1,2,3
Drug: Methylprednisolone, Placebo
Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Placebo
Drug: Methylprednisolone, Placebo
iv administration
Also known as: Standard treatment
Length of hospitalization
the interval between randomization and discharge from the hospital without the need for supplemental oxygen
Time frame: 30 days since randomisation
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Azienda Unita Sanitaria Locale Reggio Emilia