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.
Drug: Anakinra plus oSOC
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
Drug: oSOC
Optimized Standard of Care (oSOC) on the condition of patients with COVID-19 infection and worsening respiratory symptoms.
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
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
- Known hypersensitivity to Anakinra
- Absolute neutrophil count (ANC)< 1500/mm3
- Liver cirrhosis Child-Pugh Score 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-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.
CHRU de TOURS
Tours, France
Alexandra AUDEMARD-VERGER, MD-PhD, Study Director
University Hospital of Tours