COVID-19
Conditions
Interventions
Product Name: Aldesleukin
Product Code: ILT101
Pharmaceutical Form: Concentrate for cutaneous solution
CAS Number: 110942-02-4
Current Sponsor code: ILT101
Other descriptive name: ALDESLEUKIN
Concentr
Sponsors
Assistance Publique Hôpitaux de Paris
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, age = 18 years - Laboratory (RT-PCR) confirmed infection with SARS-CoV2 - Patient is intubated and mechanically ventilated - Diagnosis of ARDS according to the Berlin definition of ARDS - Onset of ARDS =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Previous history of ARDS in the last month 2. Chronic respiratory diseases requiring long-term oxygen therapy and/or long-term respiratory assistance 3. Allogeneic bone marrow transplantation 4. Active cancer 5. Liver cirrhosis with basal Child and Pugh of C 6. Pulmonary fibrosis 7. Patient with end-of-life decision 8. Patient not expected to survive for 24 hours 9. Woman known to be pregnant, lactating or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test 10. Patient already enrolled in another interventional pharmacotherapy protocol on COVID-19 11. Patient with known hypersensitivity to natural or recombinant Interleukin-2 or to any of the excipients 12. Patient with burns to = 15% of their total body surface area 13. Patient receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support 14. Patient under legal protection (protection of the court, or in curatorship or guardianship).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of low-dose interleukin 2 (Ld-IL2) administration in improving clinical course and oxygenation parameters in patients with SARS-CoV2-related ARDS. ;Secondary Objective: To assess the safety of low dose interleukin-2 (Ld-IL2) compared with placebo -To demonstrate that Ld-IL2 improves the components of the composite endpoint of mortality and duration of mechanical ventilation. -To demonstrate that Ld-IL2 shortens SARS-CoV2-related ARDS resolution -To demonstrate that Ld-IL2 shortens mechanical ventilation weaning process in SARS-CoV2-related ARDS -To demonstrate that Ld-IL2 reduces nursing workload, rate of prone positioning -To demonstrate that Ld-IL2 reduces the number of days alive in hospital during 28 days -To demonstrate that Ld-IL2 reduces the number of organ dysfunctions - Exploratory objectives ;Primary end point(s): The PaO2/FiO2 ratio at D7;Timepoint(s) of evaluation of this end point: Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in Tregs between Baseline and Day 7 (expressed in %) • - Number of days alive with oxygen therapy within 28 days • - Maximal oxygen rate within 28 days • - Number of days alive free of invasive or non-invasive ventilation within 28 days • - Number of days alive outside ICU within 28 days • - Number of days alive outside hospital within 28 days • - Time (in days) from randomization to death • - Mortality rate at D28 • - Difference between CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7) • - Use of antibiotics for respiratory (proved or suspected) infection within 28 days • - Number of prone positioning sessions Immunomonitoring study. Changes in Tregs and in other immunological, inflammatory or cellular parameters during the different visits between baseline and day 28 will be analyzed using ANOVA for ranks considering factor time and treatment .The antiviral TCR identified in BAL will be compare the TCR identified in blood by Mann-Whitney test. Multivariate methods will be used to identify relationships between immune-inflammatory profiles and clinical outcomes of the study. • Tregs percentages and numbers during induction period and throughout the follow up period at day 5, 7, 11, 14 and 28 compared to baseline before the first IL-2 injection. • Deep Immunophenotyping of immune cells at Day 7, and Day 14 compared to baseline • Cytokines and other solubles markers at Day 7, and Day 14 compared to baseline. • T cell repertoire on Treg, CD4 and CD8 Teff after sorting from blood at Day 7 and Day 14 and compared to baseline • Single cells sequencing will be performed in BAL at Day 7 and Day 14 and compared to baseline. ;Timepoint(s) of evaluation of this end point: see protocol v1.0 | — |
Countries
France
Contacts
Public ContactDRCI
Assistance Publique Hôpitaus de Paris
Outcome results
None listed