COVID-19 infection
Conditions
Interventions
Trade Name: Kineret
Product Name: Kineret
Pharmaceutical Form: Injection
Sponsors
CHRU de TOURS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female= 18 years of age - Written informed consent of the patient or a proxy - Ability for participant to comply with the requirements of the study - Hospitalized patient with COVID-19 defined as • Positive SARS-CoV2 RT-PCR • Or typical COVID-19 Radiographic infiltrates on the CT scan (peripheral ground glass without lung cavitation, lymphadenopathy, or pulmonary nodules) other non COVID-19 diagnosis ruled out. - Patient with respiratory symptoms and requirement of oxygen therapy as defined: • Oxygen therapy >= 4L/min to maintain Sp02>92% and respiratory rate >=24/min. • Or patients under oxygen >= 1L/min and presenting worsening of oxygen requirement defined by an increase of oxygen therapy >= 2L/min to maintain Sp02>92%. - Inflammatory component C-Reactive Protein = 50mg/L. - Patients within the first 20 days from the onset of the first COVID-19 symptoms - Probabilistic antibiotics therapy according to local practice Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 192
Exclusion criteria
Exclusion criteria: - Respiratory failure related to other cause than COVID-19 - Patients requiring mechanical ventilation at inclusion or requiring oxygen therapy equal or more than 11 liters per min to maintain Sp02>92% - Infectious diseases such as severe bacterial infections, aspergillosis, HIV, active HCV, active HBV, active tuberculosis - Contra indication to anti-IL1 receptor • Known hypersensitivity to Anakinra • Absolute neutrophil count (ANC)< 1500/mm3 • Liver cirrhosis score de Child-Pugh class C • Live or attenuated vaccine in the past 8 weeks • Pregnant or breast-feeding women - Patients with either legally protected status or who have been deprived of their freedom - Patient included in other interventional therapeutic research (e.g. = concurrent participation in French CoVID-19 is accepted) - Patients who have received previous treatment by anti-IL6R, anti-IL-6, anti-IL1R, anti-IL1 or anti-TNFa within 21 days preceding inclusion - Absence of Health Insurance - Existence of any life-threatening co-morbidity or any other medical condition which,in the opinion of the investigator, makes the patient unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 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). ;Timepoint(s) of evaluation of this end point: 14 days;Main Objective: 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. ;Secondary Objective: 1. To assess the efficacy of Anakinra + oSOC as compared to oSOC alone on: - Treatment success (same definition than primary outcome) up to Day 28 - Patient’s condition as defined by the OMS 7 point scale up to Day 28 - Patient’s mortality up to Day 28 - Patient’s admission in ICU - Pulmonary function (need for ventilator support, SP02, PaO2/FiO2) up to Day 28 - Inflammation parameters up to Day 28 2. To evaluate the safety profile of Anakinra 3. To identify Biomarkers of efficacy of Anakinra. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Efficacy outcomes: - Treatment success (same definition as the Primary outcome) at Day 3, Day 10 and Day 28 - OMS progression scale (on a 7-point ordinal scale): at Day 3, Day 10, Day 14 and Day 28 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. - Overall survival at Day 3, Day 10, Day 14 and Day 28 - Time to ICU admission - Time to ventilatory support (ECMO, invasive mechanical ventilation, non-invasive ventilation, high flow oxygen therapy) - Change in NEWs score from baseline to Day 3, Day 10, Day 14 and Day 28 - Change in HScore from baseline to Day 3, Day 10, Day 14 and Day 28 - Change in inflammatory parameters (CRP, ferritin, D-dimer, fibrinogen, lymphocytes count, platelet count) from baseline to Day 3, Day 10, Day 14 and Day 28 - Hospital length of stay: Time from inclusion to hospital discharge For those admitted in ICU: - Need for Vasopressors (yes or no) - If IMV, Evolution of SpO2/FIO2 - If IMV, Evolution of PaO2/FiO2 ratio - ICU length of stay: Time from admission in ICU to ICU discharge Secondary outcomes of the trial will be updated according to the COS for COVID-19. 2. The safety outcomes: Occurrence of serious adverse events during the study, including bacterial infection, septic shock, hepatitis (SGOT/SGPT, alkaline phosphatase, gammaGT) and neutropenia (Blood count). 3. Predictors of efficacy of Anakinra: The association between several of clinical parameters at inclusion (including level of oxygen requirement, respiratory rate, temperature…), biological parameters (including, CRP, ferritin, LDH, lymphocyte count, eosinophil count, Ddimers, platelet count, polymorphonuclear count...), and cytokines profile analysis with the pr | — |
Countries
France
Contacts
Public ContactClinical Research Associate
CHRU de TOURS
Outcome results
None listed