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| Name | Class |
|---|---|
| Complejo Hospitalario de Navarra | OTHER |
| Hospital Sant Joan Despà Moisès Broggi | UNKNOWN |
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Around 30% of admitted patients with COVID-19 pneumonia develop a hyper-inflammatory state whose progression to an acute respiratory distress syndrome (ARSD) could be prevented by the early initiation of immune-modulatory agents. The role of glucocorticoids (GC) in this setting remains controversial. This study aims to assess the safety and effectiveness of GC pulses to improve the clinical outcomes of patients with COVID-19 pneumonia with risen inflammatory biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone Arm | Experimental | Standard of care plus Methylprednisolone |
|
| Placebo Arm | Placebo Comparator | Standard of care plus placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | -A dose of 120 mg/day of methylprednisolone for 3 days, administered by intravenous infusión |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients developing treatment failure | • Death | At 14 days after randomization |
| Proportion of patients developing treatment failure | • Need for admission in an intensive care unit (ICU) | At 14 days after randomization |
| Proportion of patients developing treatment failure | • Need for mechanical ventilation | At 14 days after randomization |
| Proportion of patients developing treatment failure | • Decrease in SpO2 <90% (in ambient air) or PaO2 <60 mmHg (in ambient air) or PaO2FiO2 <300 mmHg, associated with radiological impairment | At 14 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at day 28 | At 28 days after randomization | |
| Proportion of patients requiring ICU admission | At 28 days after randomization | |
| Proportion of patients requiring rescue-therapy with tocilizumab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iñigo Les Bujanda, PhD | Complejo Hospitalario de Navarra | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sant Joan Despà Moisès Broggi | Sant Joan Despà | Barcelona | Spain | |||
| Complejo Hospitalario de Navarra |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33430891 | Derived | Les Bujanda I, Loureiro-Amigo J, Bastons FC, Guerra IE, Sanchez JA, Murgadella-Sancho A, Rey RG, Lopez JL, Alvarez JS. Treatment of COVID-19 pneumonia with glucocorticoids (CORTIVID): a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Jan 11;22(1):43. doi: 10.1186/s13063-020-04999-4. |
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All collected IPD will be available for exploitation in future research projects. This statement also includes the availability of the study protocol, the statistical analysis plan, the informed consent form, the clinical study report and the analytic code.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Placebo | Other | -An infusion bag of 100 mL of 0.9% saline |
|
| At 14 days after randomization |
| Length of hospital stay | Time in days from randomization until the date of hospital discharge. | At 28 days after randomization |
| Proportion of severe adverse events | Any undesirable experience related to the use of the studied drugs, which causes patient's death, life-threatening risk, hospitalization or extension of a previous hospitalization, disability or permanent damage, requires intervention to prevent permanent impairment or damage, or is considered medically relevant | At 28 days after randomization |
| Proportion of bacterial, fungal or opportunistic infections | At 28 days after randomization |
| Evolution of inflammatory biomarkers related to COVID-19 | Change in plasma levels of C-reactive protein (CRP) | At 14 days after randomization |
| Evolution of inflammatory biomarkers related to COVID-19 | Change in plasma levels of ferritin | At 14 days after randomization |
| Evolution of inflammatory biomarkers related to COVID-19 | Change in plasma levels of interleukin-6 (IL-6) | At 14 days after randomization |
| Evolution of inflammatory biomarkers related to COVID-19 | Change in plasma levels of lactate dehydrogenase (LDH) | At 14 days after randomization |
| Evolution of inflammatory biomarkers related to COVID-19 | Change in plasma levels of D-dimer (DD) | At 14 days after randomization |
| Proportion of SARS-CoV-2 clearance. | Negativization of RT-PCR for SARS-CoV-2 on nasopharyngeal swab or sputum | At 7 days after randomization |
| Pamplona |
| Navarre |
| 31008 |
| Spain |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |