Phase 2
N=161
CORIMUNO-ANA: Trial Evaluating Efficacy Of Anakinra In Patients With Covid-19 Infection
Corona Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT04341584 ↗Enrolled (actual)
161
Serious AEs
45.5%
Results posted
Jun 2025
Primary outcome: Primary: Percentage of Participants With Non-invasive Ventilation, Mechanical Ventilation or Death at Day 14 -- Severe COVID Population (WHO Clinical Progression Scale =5 at Baseline) — 47; 51 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Anakinra (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Non-invasive Ventilation, Mechanical Ventilation or Death at Day 14 -- Severe COVID Population (WHO Clinical Progression Scale =5 at Baseline) |
47; 51 | — |
| PRIMARY Percentage of Participants With WHO Clinical Progression Scale > 5 at Day 4 -- Severe COVID Population (WHO Clinical Progression Scale =5 at Baseline) |
36; 38 | — |
| PRIMARY Cumulative Incidence (Percentage) of Participants With Successful Tracheal Extubation at Day 14 -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline) |
50; 40 | — |
| PRIMARY Percentage of Participants With a Decrease of at Least One Point in WHO Clinical Progression Scale Score at Day 4 -- Critical COVID Population (WHO Clinical Progression Scale >5) |
36; 10 | — |
| SECONDARY WHO Clinical Progression Scale |
5; 5; 7; 6; NA; NA | — |
| SECONDARY Percentage of Participants Surviving (Overall Survival) |
85; 76; 91; 85; 78; 76 | — |
| SECONDARY Mean of Ventilator Free-days at Day 28 -- Critical COVID Population (WHO-clinical Progression Scale >5 at Baseline) |
14.4; 14.8 | — |
| SECONDARY PaO2/FiO2 Ratio -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline) |
175.0; 118.7; 114.5; 136.1; 182.0; 142.0 | — |
| SECONDARY Cumulative Incidence (Percentage of Participants) of Oxygen Supply Independency |
63; 69; 59; 50; NA; NA | — |
| SECONDARY Cumulative Incidence (Percentage of Participants) of Discharge From Hospital |
58; 62; 41; 40; NA; NA | — |
| SECONDARY Cumulative Incidence (Percentage of Participants) of Intensive Care Unit Discharge -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline) |
65; 65; 88; 82 | — |
Summary
The overall objective of the study is to determine the therapeutic effect and tolerance of Anakinra in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Anakinra (ANA) is a recombinant human decoy IL-1Ra and therefore blocks IL-1α and IL-1β. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Anakinra administration to patients enrolled in the CORIMUNO-19 cohort. Anakinra will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Anakinra will receive standard of cares. Outcomes of Anakinra -treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.
Eligibility Criteria
Inclusion Criteria
- Patients included in the CORIMUNO-19 cohort
- Patients with C-reactive protein level (CRP) > 25 mg / L the day or the day before the infusion)
- Patients belonging to one of the 2 following groups:
- Group 1: patients meeting all of the following criteria: 1) Requiring more than 3L/min of oxygen; 2) WHO progression scale = 5; 3) No non invasive ventilation or High flow
- Group 2: patients with respiratory failure AND (requiring mechanical ventilation OR non invasive ventilation OR High flow), with a WHO progression scale ≥ 6, and no do-not-resuscitate (DNR) order
Exclusion Criteria
- Patients with exclusion criteria to the CORIMUNO-19 cohort.
- Known hypersensitivity to Anakinra or to any of their excipients.
- Pregnancy
- Current documented bacterial infection.
- Patient with any of following laboratory results out of the ranges detailed below at screening:
- Absolute neutrophil count (ANC) ≤ 1.0 x 109/L
- Haemoglobin level: no limitation
- Platelets (PLT) 5N
- Severe renal insufficiency with Glomerular filtration rate < 30 ml / mn
Data sourced from ClinicalTrials.gov (NCT04341584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.