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NCT04673162

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

Completed Phase 3 Last updated 23 May 2022
What this trial tests

Phase 3 trial testing Methylprednisolone, Placebo in Covid19 in 260 participants. Completed in 12 July 2021.

Timeline
17 December 2020
Primary endpoint
21 April 2021
12 July 2021

Quick facts

Lead sponsorAzienda USL Reggio Emilia - IRCCS
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment260
Start date17 December 2020
Primary completion21 April 2021
Estimated completion12 July 2021
Sites20 locations across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Azienda USL Reggio Emilia - IRCCS — full company profile →

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
    Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
  2. Systemic corticosteroids for the treatment of COVID-19.
    Wagner C, Griesel M, Mikolajewska A, Mueller A, et al · · 2021 · cited 151× · PMID 34396514 · DOI 10.1002/14651858.cd014963
  3. Systemic corticosteroids for the treatment of COVID-19: Equity-related analyses and update on evidence.
    Wagner C, Griesel M, Mikolajewska A, Metzendorf MI, et al · · 2022 · cited 44× · PMID 36385229 · DOI 10.1002/14651858.cd014963.pub2
  4. Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia: a double-blind, randomised, placebo-controlled trial.
    Salvarani C, Massari M, Costantini M, Merlo DF, et al · · 2022 · cited 42× · PMID 35361632 · DOI 10.1183/13993003.00025-2022
  5. Mast cells: Therapeutic targets for COVID-19 and beyond.
    Lam HY, Tergaonkar V, Kumar AP, Ahn KS. · · 2021 · cited 17× · PMID 34467628 · DOI 10.1002/iub.2552
  6. Effect of corticosteroids in patients with COVID-19: a Bayesian network meta-analysis.
    Wang X, Wen D, He Q, Yang J, et al · · 2022 · cited 11× · PMID 36272700 · DOI 10.1016/j.ijid.2022.10.021

Verify or expand the search:

Other recruiting trials for Covid19

Currently open trials in the same condition.

Other Azienda USL Reggio Emilia - IRCCS trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04673162.

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