|drug755||Sodium Chloride 9mg/mL Wiki||0.58|
There are 3 clinical trials
Mortality of severe Community-Acquired Pneumonia (CAP) has not declined over time and is between 25 and 30% in sub-groups of patients. Corticosteroids (CTx) could down-regulate pulmonary and systemic inflammation, accelerate clinical resolution and decrease the rate of inflammation-associated systemic complications. Two recent meta-analyses suggest a positive effect on severe CAP day 28 survival when CTx are added to standard therapy. However they are based on only four trials gathering less than 300 patients, of which only one was positive. Recently published guidelines do not recommend CTx as part of CAP treatment. Therefore a well-powered trial appears necessary to test the hypothesis that CTx - and more specifically hydrocortisone - could improve day 28 survival of critically-ill patients with severe CAP, severity being assessed either on a Pulmonary Severity Index ≥ 130 (Fine class V) or by the use of mechanical ventilation or high-FiO2 high-flow oxygen therapy. A phase-III multicenter add-on randomized controlled double-blind superiority trial assessing the efficacy of hydrocortisone vs. placebo on Day 28 all-causes mortality, in addition to antibiotics and supportive care, including the correction of hypoxemia. Randomization will be stratified on: (i) centers; (ii) use of mechanical ventilation at the time of inclusion.
Description: For the sub-group of patients included with COVID19, failure is defined as death or need of respiratory support (mechanical ventilation or high-flow oxygen therapy);Measure: Day 21 failure Time: at day 21
Description: Sub-group of patients included with COVID19Measure: P/F ratio measured daily from Day1 to Day7, at Day 14 and at Day 21 and/or at the end of ICU-stay Time: from day 1 to day 7, at day 14 and day 21 and/or at the end of ICU-stay
Description: Sub-group of patients included with COVID19Measure: Proportion of patients needing endotracheal intubation Time: at day 21
Description: Sub-group of patients included with COVID19Measure: Proportion of patients experiencing secondary infection during their ICU-stay Time: From baseline to day 21
We aim to assess the benefits and harms of low-dose hydrocortisone in patients with COVID-19 and severe hypoxia.
Description: Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 28Measure: Days alive without life support at day 28 Time: Day 28 after randomisation
Description: Death from all causesMeasure: All-cause mortality at day 28 Time: Day 28 after randomisation
Description: Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 90Measure: Days alive without life support at day 90 Time: Day 90 after randomisation
Description: Death from all causesMeasure: All-cause mortality at day 90 Time: Day 90 after randomisation
Description: Defined as new episodes of septic shock, invasive fungal infection, clinically important GI bleeding or anaphylactic reactionMeasure: Number of participants with one or more serious adverse reactions Time: Day 14 after randomisation
Description: Number of days alive and out of hospital not limited to the index admissionMeasure: Days alive and out of hospital at day 90 Time: Day 90 after randomisation
Description: Death from all causesMeasure: All-cause mortality at 1 year after randomisation Time: 1 year after randomisation
Description: Assessed by EQ-5D-5LMeasure: Health-related quality of life at 1 year Time: 1 year after randomisation
Description: Assessed by EQ-VASMeasure: Health-related quality of life at 1 year Time: 1 year after randomisation
To date, there is no efficient therapeutics to prevent or treat COVID-19 related pulmonary failure. Corticosteroids (CS) could be a helpful therapeutic. Retrospective reports suggested survival improvement in patients with acute respiratory distress syndrome (ARDS). CT scan for COVID19 hospitalized patients showed sometimes unusual aspects of pneumonia, suggestive of an organizing phase of diffuse alveolar damage (DAD). We hypothesize that, in the context of alveolar aggression induced by COVID-19, CT scan could help to individualize patients with a high probability of pulmonary organizing process who could benefit from CS treatment.
Description: The 7-category ordinal scale is as follow: Not hospitalized with resumption of usual activities Not hospitalized, but unable to resume usual activities Hospitalized, not requiring O2 Hospitalized, requiring O2 from 1 to 5 l/min Hospitalized, requiring O2 >6 l/min, nasal high-flow O2, non-invasive mechanical ventilation, or both Hospitalized, requiring ECMO, invasive mechanical ventilation, or both Death.Measure: Clinical improvement defined by the improvement of 2 points on a 7-category ordinal scale, at 14 days. Time: 14 days