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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A SOC plus MP | Experimental | Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Methylprednisolone 1gr daily iv on days 1,2,3 |
|
| B SOC plus Pb | Active Comparator | Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone, Placebo | Drug | iv administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospitalization | the interval between randomization and discharge from the hospital without the need for supplemental oxygen | 30 days since randomisation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Costantini, MD | AUSL-IRCCS di Reggio Emilia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UO di Malattie Infettive, Azienda Sociosanitaria Ligure 1 | Sanremo | Imperia | 18038 | Italy | ||
| SOC di Pneumologia, Az. Osp. S. Antonio e Biagio e C. Arrigo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35361632 | Derived | Salvarani C, Massari M, Costantini M, Merlo DF, Mariani GL, Viale P, Nava S, Guaraldi G, Dolci G, Boni L, Savoldi L, Bruzzi P, Turra C, Catanoso M, Marata AM, Barbieri C, Valcavi A, Franzoni F, Cavuto S, Mazzi G, Corsini R, Trapani F, Bartoloni A, Barisione E, Barbieri C, Burastero GJ, Pan A, Inojosa W, Scala R, Burattini C, Luppi F, Codeluppi M, Tarek KE, Cenderello G, Salio M, Foti G, Dongilli R, Bajocchi G, Negri EA, Ciusa G, Fornaro G, Bassi I, Zammarchi L, Aloe T, Facciolongo N. Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia: a double-blind, randomised, placebo-controlled trial. Eur Respir J. 2022 Oct 20;60(4):2200025. doi: 10.1183/13993003.00025-2022. Print 2022 Oct. |
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all IPD that underlie results in a publication
As soon as the main results have been published
publication reviewers
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Randomized, multicentric, double blind
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Placebo controlled
| Alessandria |
| 15121 |
| Italy |
| UO di Pneumologia, Ospedale San Donato | Arezzo | 52100 | Italy |
| UO di Malattie Infettive, Policlinico Sant'Orsola Malpighi | Bologna | 40138 | Italy |
| UO di Pneumologia e Terapia Intensiva Respiratoria, Policlinico Sant' Orsola Malpighi | Bologna | 40138 | Italy |
| Reparto di Malattie Infettive, Comprensorio Sanitario di Bolzano- Az. Sanitaria Alto Adige | Bolzano | 39100 | Italy |
| SOC di Malattie Infettive, ASST di Cremona | Cremona | 26100 | Italy |
| SOC di Malattie Infettive, AOU Careggi | Florence | 50134 | Italy |
| UOC di Pneumologia, IRCCS Ospedale Policlinico San Martino | Genova | 16132 | Italy |
| SC di Malattie Infettive,Ospedale Sant'Andrea - Az. Sociosanitaria Ligure 5 | La Spezia | 19121 | Italy |
| UO Malattie Infettive, Azienda Ospedaliera Universitaria- Policlinico di Modena | Modena | 41124 | Italy |
| UO Clinica Pneumologica - Ospedale "San Gerardo" - ASST di Monza | Monza | 20900 | Italy |
| UO Terapia Anestesia e Rianimazione - Ospedale "San Gerardo" - ASST di Monza | Monza | 20900 | Italy |
| UO di Malattie Infettive, Ospedale Guglielmo da Saliceto - AUSL di Piacenza | Piacenza | 29100 | Italy |
| UO di Pneumologia, Ospedale Guglielmo da Saliceto - AUSL di Piacenza | Piacenza | 29100 | Italy |
| SOC di Malattie Infettive - AUSL-IRCCS di Reggio Emilia | Reggio Emilia | 42123 | Italy |
| SOC di Pneumologia - AUSL-IRCCS di Reggio Emilia | Reggio Emilia | 42123 | Italy |
| SOC di Reumatologia, AUSL- IRCCS di Reggio Emilia | Reggio Emilia | 42123 | Italy |
| UOC di Malattie Infettive - Azienda Unità Locale Socio Sanitaria n. 2 | Treviso | 31100 | Italy |
| UO di Pneumologia, Azienda Ospedaliera Universitaria Integrata | Verona | 37126 | Italy |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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