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This is a double-blind, randomized, placebo-controlled, phase IIb clinical trial to assess the efficacy of injectable methylprednisolone sodium succinate (MP) in patients with severe acute respiratory syndrome (SARS) in COVID-19 infection. A total of 416 individuals of both sexes, aged over 18 years old, with symptoms suggestive or confirmed diagnosis of severe acute respiratory syndrome (SARS), hospitalized at the Hospital and Pronto-Socorro Delphina Rinaldi Abdel Aziz (HPSDRAA), with clinical and radiological findings suggestive of SARS-CoV2 infection, will be randomized at a 1:1 ration to receive either MP (0.5mg/kg of weight, twice daily, for 5 days) or placebo (saline solution, twice daily, for 5 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone | Active Comparator | 0.5mg/kg injectable methylprednisolone sodium succinate, twice daily, for 5 days. |
|
| Placebo | Placebo Comparator | Saline solution, twice daily, for 5 days. Injectable. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone Sodium Succinate | Drug | injectable solution at a dose of 0.5mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate at day 28 | Mortality rate on day 28, after randomization | on day 28, after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate on days 7, 14 and 28 | Proportion of patient that died on days 7, 14 and 28. | after randomization, up to 28 days. |
| Incidence of orotracheal intubation | proportion of patients requiring orotracheal intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Spirometry (exploratory outcome) | Forced expiratory capacity at the first second of exhalation (FEV1) in liters | 120 days after randomization |
| Spirometry (exploratory outcome) | Forced vital capacity (FVC) in liters |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz | Manaus | Amazonas | 69093-415 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34917633 | Derived | Barros CMSS, Freire RS, Frota E, Rezende Santos AG, Farias MEL, Rodrigues MGA, Silva BM, Prado Jeronimo CM, Netto RLA, Silva Borba MG, Baia-da-Silva D, Brito-Sousa JD, Xavier MS, Araujo-Alexandre MA, Sampaio VS, Melo GC, Areas GT, Hajjar LA, Monteiro WM, Gomes Naveca F, Costa FTM, Val FFA, Lacerda MVG; Metcovid team. Short-Course of Methylprednisolone Improves Respiratory Functional Parameters After 120 Days in Hospitalized COVID-19 Patients (Metcovid Trial): A Randomized Clinical Trial. Front Med (Lausanne). 2021 Nov 30;8:758405. doi: 10.3389/fmed.2021.758405. eCollection 2021. | |
| 32785710 |
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all patient data will be shared after study publication
after study publication.
upon formal request.
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| Placebo solution | Drug | injectable saline solution |
|
|
| after randomization, up to 7 days. |
| Change in oxygenation index | Proportion of patients with oxygenation index (PaO2 / FiO2) < 100 in 7 days. | after randomization, up to 7 days. |
| 120 days after randomization |
| Spirometry (exploratory outcome) | FEV1/FVC ratio | 120 days after randomization |
| Spirometry (exploratory outcome) | Forced expiratory flow (FEF) in cmH2O | 120 days after randomization |
| Spirometry (exploratory outcome) | Peak expiratory flow (PEF) in cmH2O | 120 days after randomization |
| Derived |
| Jeronimo CMP, Farias MEL, Val FFA, Sampaio VS, Alexandre MAA, Melo GC, Safe IP, Borba MGS, Netto RLA, Maciel ABS, Neto JRS, Oliveira LB, Figueiredo EFG, Oliveira Dinelly KM, de Almeida Rodrigues MG, Brito M, Mourao MPG, Pivoto Joao GA, Hajjar LA, Bassat Q, Romero GAS, Naveca FG, Vasconcelos HL, de Araujo Tavares M, Brito-Sousa JD, Costa FTM, Nogueira ML, Baia-da-Silva DC, Xavier MS, Monteiro WM, Lacerda MVG; Metcovid Team. Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With Coronavirus Disease 2019 (COVID-19; Metcovid): A Randomized, Double-blind, Phase IIb, Placebo-controlled Trial. Clin Infect Dis. 2021 May 4;72(9):e373-e381. doi: 10.1093/cid/ciaa1177. |
| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D011014 | Pneumonia |
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D011024 | Pneumonia, Viral |
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| ID | Term |
|---|---|
| D008776 | Methylprednisolone Hemisuccinate |
| 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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