COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04364009

Alexandra AUDEMARD-VERGER, MD-PhD

a.audemardverger@chu-tours.fr

2020-04-27

Terminated

RCT

Randomized

Parallel

Open label

single-center

Treatment

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.

None

2

University Hospital, Tours

18

None

France

Severe disease at enrollment

6: Severe disease at enrollment

71

Treatment success

None

Phase 3

[{"arm_notes": "", "treatment_id": 83, "treatment_name": "Anakinra", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]