Name (Synonyms) | Correlation | |
---|---|---|
D012818 | Signs and Symptoms, Respiratory NIH | 0.50 |
Name (Synonyms) | Correlation |
---|
There is one clinical trial.
The main objective of the ANACONDA-COVID-19 trial is to assess the efficacy of Anakinra + optimized Standard of Care (oSOC) as compared to oSOC alone on the condition of patients with COVID-19 infection and worsening respiratory symptoms. Success defined as patient alive and free of invasive mechanical ventilation (IMV) and free of Extracorporeal Membrane Oxygenation (ECMO) at Day 14.
Description: The primary endpoint is treatment success at Day 14, defined as a patient alive and not requiring any of the following: Invasive mechanical ventilation (IMV) or Extracorporeal membrane oxygenation (ECMO).
Measure: Treatment success Time: After 14 days of treatmentDescription: Defined as a patient alive and not requiring any of the following: Invasive mechanical ventilation (IMV) or Extracorporeal membrane oxygenation (ECMO).
Measure: Treatment success Time: After 3 days, 10 days and 28 days of treatmentDescription: 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: OMS progression scale (on a 7 point ordinal scale) Time: After 3 days, 10 days, 14 days and 28 days of treatmentDescription: Overall survival
Measure: Overall survival Time: After 3 days, 10 days, 14 days and 28 days of treatmentDescription: Time to ICU admission
Measure: Time to ICU admission Time: Up to 28 daysDescription: Time to ventilatory support : extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, non-invasive ventilation, high flow oxygen therapy)
Measure: Time to ventilatory support Time: Up to 28 daysDescription: The National Early Warning Score (NEWS) determines the degree of illness of a patient using six physiological findings and one observation. Score from 0 to 20, 0 mean a worse outcome, 20 mean a better outcome
Measure: Change in National Early Warning Score (NEW)from baseline to Day 3, Day 10, Day 14 and Day 28 Time: After 3 days, 10 days, 14 days and 28 days of treatmentDescription: C-reactive proteine (mg/L)
Measure: Change in inflammatory parameter Time: From baseline to Day 3, Day 10, Day 14 and Day 28Description: ferritin (ng/mL)
Measure: Change in inflammatory parameter Time: From baseline to Day 3, Day 10, Day 14 and Day 28Description: lymphocyte count (G/L)
Measure: Change in inflammatory parameter Time: From baseline to Day 3, Day 10, Day 14 and Day 28Description: fibrinogen (g/l)
Measure: Change in inflammatory parameter Time: From baseline to Day 3, Day 10, Day 14 and Day 28Description: Hospital length of stay
Measure: Hospital length of stay Time: Up to 28 daysDescription: Need for Vasopressors (yes or no)
Measure: ICU parameter Time: Up to 28 daysDescription: Evolution of SpO2/FIO2 ratio (no unit)
Measure: ICU parameter Time: Up to 28 daysDescription: Evolution of PaO2/FiO2 ratio (no unit)
Measure: ICU parameter Time: Up to 28 daysDescription: Occurrence of serious adverse events during the study, including infection (bacterial, parasitic, mycotic and viral infection), septic shock, Ankanira hypersensitivity, hepatic damages (SGOT/SGPT, alkaline phosphatase, gammaGT) and neutropenia (Blood count).
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Time: Up to 28 daysDescription: The correlation between several of clinical parameters at inclusion (including level of oxygen requirement (saturation), respiratory rate (per min), temperature (°C)…), biological parameters :including, CRP (mg/L), ferritin (µg/L), LDH (UI/L), lymphocyte count (G/L), eosinophil count (G/L), Ddimers (ng/mM), platelet count (G/L), polymorphonuclear count (G/L)...with the primary end point will be explored.
Measure: Predictors of efficacy of Anakinra Time: After 14 days of treatment