Status:
TERMINATED
Anakinra for COVID-19 Respiratory Symptoms
Lead Sponsor:
University Hospital, Tours
Collaborating Sponsors:
INSERM CIC-P 1415, University Hospital Center of Tours
Swedish Orphan Biovitrum
Conditions:
COVID-19 Infection
ANAKINRA Treatment
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 infecti...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2020
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04364009
Start Date
April 27 2020
End Date
November 3 2020
Last Update
January 15 2021
Active Locations (1)
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1
CHRU de TOURS
Tours, France, 37044