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NCT04673162
Evaluation of the Efficacy of High Doses of Methylprednisolone in SARS-CoV2 ( COVID-19) Pneumonia Patients
Phase 3 trial testing Methylprednisolone, Placebo in Covid19 in 260 participants. Completed in 12 July 2021.
21 April 2021
Quick facts
| Lead sponsor | Azienda USL Reggio Emilia - IRCCS |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 260 |
| Start date | 17 December 2020 |
| Primary completion | 21 April 2021 |
| Estimated completion | 12 July 2021 |
| Sites | 20 locations across Italy |
Drugs / interventions tested
- Methylprednisolone, Placebo
Conditions studied
- Covid19 — all drugs for Covid19 →
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):
-
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT04673162
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Azienda USL Reggio Emilia - IRCCS trials
Trials by the same sponsor.
- NCT07373626 — Physical Activity Trends in Cancer Survivors Treated at the 'MOvement and REhabilitation' Clinic · recruiting
- NCT07000162 — LAttice Radiation Therapy for Large Lesions: Reggio Emilia Single-arm Phase II Trial · Phase 2 · recruiting
- NCT06629896 — Contrast Enhancement Mammography vs MRI for the Surveillance of Women at High Risk of Breast Cancer: Con-trust Randomize · NA · recruiting
- NCT06749600 — Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma · recruiting
- NCT06624280 — Does Orthopedic Surgery Improve Gait Efficiency in Children With Cerebral Palsy? A Retrospective Study · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04673162 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Azienda USL Reggio Emilia - IRCCS
- Last refreshed: 23 May 2022
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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