Trials / Completed
CompletedNCT04673162
Evaluation of the Efficacy of High Doses of Methylprednisolone in SARS-CoV2 ( COVID-19) Pneumonia Patients
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 260 (actual)
- Sponsor
- Azienda USL Reggio Emilia - IRCCS · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Methylprednisolone, Placebo | iv administration |
Timeline
- Start date
- 2020-12-17
- Primary completion
- 2021-04-21
- Completion
- 2021-07-12
- First posted
- 2020-12-17
- Last updated
- 2022-05-23
Locations
20 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT04673162. Inclusion in this directory is not an endorsement.