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HydrocortisoneWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug755 Sodium Chloride 9mg/mL Wiki 0.58
drug648 Prednisone Wiki 0.41
drug616 Placebo Wiki 0.06

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D000860 Hypoxia NIH 0.19
D011014 Pneumonia NIH 0.10

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.09

There are 3 clinical trials

Clinical Trials


1 Effects of Low-dose Corticosteroids on Survival of Severe Community-acquired Pneumonia

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.

NCT02517489 Community Acquired Pneumonia Drug: Hydrocortisone Drug: Placebo
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Day 28 all causes mortality

Time: at day 28

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

Secondary Outcomes

Measure: In patients non-invasively ventilated at inclusion, proportion of patients needing endotracheal intubation

Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

Measure: In patients non-ventilated at inclusion, proportion of patients requiring non-invasive ventilation

Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

Measure: In patients non-ventilated at inclusion, proportion of patients needing endotracheal intubation

Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

Measure: Day 28 ventilator-free-days

Time: between 0 and day 28

Measure: Number of patients with vasopressor therapy initiation from inclusion to day 28

Time: between 0 and day 28

Measure: Day 28 vasopressor-free-days

Time: between 0 and day 28

Measure: ICU and/or intermediate care unit LOS

Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

Measure: All-causes mortality at day 90

Time: at day 90

Measure: SF-36 Health Survey at day 90

Time: at day 90

Measure: Biomarkers: procalcitonin at baseline, day 3 and day 7

Time: at inclusion, day 3 and day 7

Measure: Biomarkers: C-reactive protein at baseline, day 3 and day 7

Time: at inclusion, day 3 and day 7

Measure: Biomarkers: plasmatic concentration of pro-inflammatory cytokines (IL-6, IL-20, IL-22, IL-22BP, HBD2, TNF) at baseline, day 3 and day 7

Time: at inclusion, day 3 and day 7

Measure: P/F ratio measured daily from baseline to day 7, at the end of treatment, at the end of ICU-stay and/or day 28

Time: measured daily from baseline to day 7, at the end of treatment i.e 14 days after the start of treatment, at the end of ICU-stay (for a maximum of 28 days) and/or day 28

Measure: SOFA calculated daily from baseline to day 7, at the end of treatment, at the end of ICU-stay and/or day 28

Time: calculated daily from baseline to day 7, at the end of treatment (i.e 14 days after the start of treatment), at the end of ICU-stay (for a maximum of 28 days) and/or day 28

Measure: Proportion of patients experiencing secondary infection during their ICU-stay

Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

Measure: Proportion of patients experiencing gastrointestinal bleeding during their ICU-stay

Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

Measure: Daily amount of insulin administered to the patient from day 1 to day 7

Time: Patients will be followed from day 1 to day 7

Measure: Weight-gain at baseline and day 7

Time: Patients will be followed at baseline and day 7

Other Outcomes

Description: Sub-group of patients included with COVID19

Measure: 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 COVID19

Measure: Proportion of patients needing endotracheal intubation

Time: at day 21

Description: Sub-group of patients included with COVID19

Measure: Proportion of patients experiencing secondary infection during their ICU-stay

Time: From baseline to day 21

2 Low-dose Hydrocortisone in Patients With COVID-19 and Severe Hypoxia - the COVID STEROID Trial

We aim to assess the benefits and harms of low-dose hydrocortisone in patients with COVID-19 and severe hypoxia.

NCT04348305 Covid-19 Hypoxia Drug: Hydrocortisone Drug: Sodium Chloride 9mg/mL
MeSH:Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 28

Measure: Days alive without life support at day 28

Time: Day 28 after randomisation

Secondary Outcomes

Description: Death from all causes

Measure: 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 90

Measure: Days alive without life support at day 90

Time: Day 90 after randomisation

Description: Death from all causes

Measure: 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 reaction

Measure: 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 admission

Measure: Days alive and out of hospital at day 90

Time: Day 90 after randomisation

Description: Death from all causes

Measure: All-cause mortality at 1 year after randomisation

Time: 1 year after randomisation

Description: Assessed by EQ-5D-5L

Measure: Health-related quality of life at 1 year

Time: 1 year after randomisation

Description: Assessed by EQ-VAS

Measure: Health-related quality of life at 1 year

Time: 1 year after randomisation

3 Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia in Grand Ouest Interregion France

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.

NCT04359511 COVID-19 Drug: Prednisone Drug: Hydrocortisone
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

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

Secondary Outcomes

Measure: Proportion of patients free of oxygen at day 14 and 28

Time: 14 and 28 days

Measure: Proportion of patients discharged alive from hospital at day 14 and 28

Time: 14 and 28 days

Measure: Time to discharge for patients alive

Time: 28 days

Measure: Proportion of patients that were hospitalized to ICU or who died at day 14 and 28

Time: 14 and 28 days

Measure: 14 and 28 day mortality rate

Time: 14 and 28 days


Related HPO nodes (Using clinical trials)