Anakinra for COVID-19 Respiratory Symptoms

• Status: Terminated
• Trial end date: 2020-11-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Tours
• Collaborators: INSERM CIC-P 1415, University Hospital Center of Tours; Swedish Orphan Biovitrum; Swedish Orphan Biovitrum (SOBI)
• Treatments: Interleukin 1 Receptor Antagonist Protein

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

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.