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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001734-36 | EudraCT Number | ||
| DR200111 | Other Identifier | University Hospital of Tours |
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Efficiency and safety reasons
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| Name | Class |
|---|---|
| INSERM CIC-P 1415, University Hospital Center of Tours | UNKNOWN |
| Swedish Orphan Biovitrum | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimized Standard of Care (oSOC) | Active Comparator | The control group will receive optimized standard of care alone, including all treatments authorized for COVID-19 by the French Health Ministry and/or the center COVID-19 therapeutic committees at inclusion and during the follow-up. |
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| Anakinra plus Optimized Standard of Care (oSOC) | Experimental | The experimental group will receive Anakinra plus optimized Standard of Care. The patients will receive Intravenous injection (IV) of Anakinra 400mg/day (100mg IV every 6 hours) at Day 1, 2 and 3. From Day 4 to Day 10, the patient will receive IV injection of Anakinra 200mg/day (100mg every 12 hours). The total duration of Anakinra is 10 Days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anakinra plus oSOC | Drug | Anakinra plus Optimized Standard of Care (oSOC) on the condition of patients with COVID-19 infection and worsening respiratory symptoms. The patients will receive intraveinous injection of Anakinra 400mg from Day 1 to Day 3 (two injections of 100 mg each 12 hours) and 200mg the remaining 7 days. The total duration of Anakinra is 10 Days. Efficient dosage of Anakinra as previously described will be continued until Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success | 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). | After 14 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success | Defined as a patient alive and not requiring any of the following: Invasive mechanical ventilation (IMV) or Extracorporeal membrane oxygenation (ECMO). | After 3 days, 10 days and 28 days of treatment |
| OMS progression scale (on a 7 point ordinal scale) |
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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
Patient with respiratory symptoms and requirement of oxygen therapy as defined:
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
Non-inclusion 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
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-TNFα 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.
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra AUDEMARD-VERGER, MD-PhD | University Hospital of Tours | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de TOURS | Tours | 37044 | France |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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ANACONDA study is a French multicentre, open-label, randomized, controlled superiority trial comparing the administration of optimized standard of care and Anakinra versus optimized standard of care alone in patients hospitalized in a medical unit with COVID-19.
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| oSOC | Drug | Optimized Standard of Care (oSOC) on the condition of patients with COVID-19 infection and worsening respiratory symptoms. |
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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. |
| After 3 days, 10 days, 14 days and 28 days of treatment |
| Overall survival | Overall survival | After 3 days, 10 days, 14 days and 28 days of treatment |
| Time to ICU admission | Time to ICU admission | Up to 28 days |
| Time to ventilatory support | Time to ventilatory support : extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, non-invasive ventilation, high flow oxygen therapy) | Up to 28 days |
| Change in National Early Warning Score (NEW)from baseline to Day 3, Day 10, Day 14 and Day 28 | 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 | After 3 days, 10 days, 14 days and 28 days of treatment |
| Change in inflammatory parameter | C-reactive proteine (mg/L) | From baseline to Day 3, Day 10, Day 14 and Day 28 |
| Change in inflammatory parameter | ferritin (ng/mL) | From baseline to Day 3, Day 10, Day 14 and Day 28 |
| Change in inflammatory parameter | lymphocyte count (G/L) | From baseline to Day 3, Day 10, Day 14 and Day 28 |
| Change in inflammatory parameter | fibrinogen (g/l) | From baseline to Day 3, Day 10, Day 14 and Day 28 |
| Hospital length of stay | Hospital length of stay | Up to 28 days |
| ICU parameter | Need for Vasopressors (yes or no) | Up to 28 days |
| ICU parameter | Evolution of SpO2/FIO2 ratio (no unit) | Up to 28 days |
| ICU parameter | Evolution of PaO2/FiO2 ratio (no unit) | Up to 28 days |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 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). | Up to 28 days |
| Predictors of efficacy of Anakinra | 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. | After 14 days of treatment |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011506 | Proteins |
| D001685 | Biological Factors |