Efficacy and safety of ANAkinra during Adult « COVID-19 » with Aggravating respiratory symptoms: a multicenter open-label controlled randomized trial

Phase 1

• Conditions: COVID-19 infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001734-36-FR
• Lead Sponsor: CHRU de TOURS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-15
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 192

Exclusion 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 score de Child-Pugh class 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-TNFa 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified