Name (Synonyms) | Correlation | |
---|---|---|
drug162 | CPAP Wiki | 0.71 |
drug337 | HFNO Wiki | 0.71 |
drug949 | conventional oxygen Wiki | 0.71 |
drug977 | mechanical ventilation Wiki | 0.71 |
drug1003 | placebo Wiki | 0.27 |
drug632 | Placebos Wiki | 0.19 |
Name (Synonyms) | Correlation |
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There are 2 clinical trials
The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality. Two hypotheses will be tested in this study. The first hypothesis is the benefit of corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival. The second hypothesis is that, in the subset of patients free of mechanical ventilation at admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory failure.
Description: The time-to-death from all causes within the first 60 days after randomization.
Measure: The time-to-death from all causes Time: day-60Description: the time to need for mechanical ventilation (MV), as defined by any of the 3 criteria for intubation within the first 28 days after randomization.
Measure: The time to need for mechanical ventilation (MV) Time: day-28.Description: The cycle threshold for SARS-CoV-2 PCR at baseline, day 7 and day 10 in samples of the same origin (preferably subglottic i.e. bronchoalveolar lavage or tracheal aspiration, otherwise nasopharyngeal swab)
Measure: The viral load in the respiratory tract Time: day-10Description: Proportion of patients with at least one episode of any healthcare-associated infection between randomization and D28
Measure: Number of patient with at least one episode of healthcare-associated infections Time: day-28Description: To compare the exposition to mechanical ventilation
Measure: Number of days alive without mechanical ventilation Time: day-28Description: Changes in SOFA (Sepsis-related Organ Failure Assessment) score. (min = 0 for normal status max = 24 for worse status)
Measure: Measure of SOFA score Time: day-28Description: to compare the exposition to renal replacement therapy
Measure: Number of days alive without renal replacement therapy Time: day-28Description: To compare the lengths of ICU
Measure: Lengths of ICU-stay Time: day-60Description: To compare the lengths of hospital-stay
Measure: Lengths of hospital-stay Time: day-60Description: Proportion of patients with severe hypoxemia, which is defined as an oxygen saturation of less than 80% during the same interval during the interval between induction and 2 minutes after tracheal intubation
Measure: Number of patients with severe hypoxemia, Time: day 60Description: Proportion of patients with cardiac arrest within 1 hour after intubation
Measure: Number of patients with cardiac arrest within 1 hour after intubation Time: day 60This trial will determine the safety and estimate efficacy of targeted corticosteroids in mechanically ventilated patients with the hyper-inflammatory sub phenotype of ARDS due to coronavirus disease 2019 (COVID-19) by implementing a Phase 2A clinical trial.
Description: Total number of ventilator free days to day 28 of hospitalization. If a patient dies prior to day 28, they will be counted as zero ventilator free days. Follow up will be performed via phone or electronically to determine ventilator free status of those patients discharged prior to day 28.
Measure: Ventilator Free Days (VFD) at Day 28 Time: 28 DaysDescription: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death.
Measure: Clinical Status at day 14 as measured by World Health Organization (WHO) 7-point ordinal scale. Time: 14 Days