Overview

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.