Methylprednisolone, Placebo
Drugiv administration
Other names: Standard treatment
NCT Number: NCT04673162
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
UO di Malattie Infettive, Azienda Sociosanitaria Ligure 1, Sanremo, Imperia, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
iv administration
Other names: Standard treatment
Time frame: 30 days since randomisation
the interval between randomization and discharge from the hospital without the need for supplemental oxygen
Azienda USL Reggio Emilia - IRCCS
Other Gov
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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