COVID 19 Clinical Trial
— LILIADE-COVIDOfficial title:
Low Dose of IL-2 In Acute Respiratory DistrEss Syndrome Related to COVID-19
Verified date | April 2021 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose is 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.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 5, 2021 |
Est. primary completion date | November 2, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male or female, age = 18 years - Laboratory (RT-PCR) confirmed infection with SARS-CoV2 - Patient is either under invasive or non-invasive mechanical ventilation (including high flow nasal oxygen therapy). - Diagnosis of ARDS according to the Berlin definition of ARDS - Onset of ARDS <96 hours - Patient with French Social Security System - A written informed consent by the designated substitute decision maker, if present. In the event of absence, the patient can be included by investigator's decision alone. Exclusion Criteria: - Previous history of ARDS in the last month - Chronic respiratory diseases requiring long-term oxygen therapy and/or long-term respiratory assistance - History of organ allograft. - Active cancer - Liver cirrhosis with basal Child and Pugh of C - Pulmonary fibrosis - Patient with end-of-life decision - Patient not expected to survive for 24 hours - Woman known to be pregnant, lactating or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test - Patient already enrolled in another interventional pharmacotherapy protocol on COVID-19 - Patient with known hypersensitivity to natural or recombinant Interleukin-2 or to any of the excipients - Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (ANC) less than 1.5x109/L, AST or ALT greater than 5 x ULN, platelets <50,000 per mm3 - Use of chronic oral corticosteroids > 10 mg prednisone equivalent a day for a non-COVID-19-related condition - Current uncontrolled autoimmune disease - Patients with uncontrolled suspected or known active systemic bacterial or fungal infections - Patient with severe, uncontrolled pre-existing (chronic) organ failure (myocardial, hepatic or renal) - Vaccination with live attenuated vaccines in the month preceding the inclusion - Patient with burns to = 15% of their total body surface area - Patient receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support - Patient under legal protection (protection of the court, or in curatorship or guardianship). |
Country | Name | City | State |
---|---|---|---|
France | Service Anesthésie Réanimation - Groupe Hospitalier Pitié-Salpêtrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Iltoo Pharma |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The PaO2/FiO2 ratio at D11 | at Day11 | ||
Secondary | Changes in Tregs between Baseline and Day 7 (expressed in %) | at Day0 and Day7 | ||
Secondary | Number of days alive with oxygen therapy within 28 days | at Day28 | ||
Secondary | Maximal oxygen rate within 28 days | at Day28 | ||
Secondary | Number of days alive free of invasive or non-invasive ventilation within 28 days | At Day28 | ||
Secondary | Number of days alive outside ICU within 28 days | at Day28 | ||
Secondary | Number of days alive outside hospital within 28 days | at Day28 | ||
Secondary | Time (in days) from randomization to death | through study completion at day 28 | ||
Secondary | Mortality rate at D28 | at Day28 | ||
Secondary | Difference between CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7) | at Day0 and Day7 or at the time of discharge | ||
Secondary | Use of antibiotics for respiratory (proved or suspected) infection within 28 days | at Day28 | ||
Secondary | Number of prone positioning sessions | throughout the follow up period at day 28 | ||
Secondary | Changes in Tregs during the different visits between baseline and day 28 | at Day0, 5, 7, 11, 14 and Day28 | ||
Secondary | Cytokines analysis on plasma samples at Day 0, 7 and 14 | To evaluate selected immune and inflammatory markers: Serum concentrations of cytokines and soluble factors related to the immune response and inflammatory processes will be evaluated and compare to baseline by multiplex immunoprofiling to analyse a larger number of molecules including at least IFNa2, IFN?, IL-1a, IL-1ß, IL-1RA, IL-2, IL-6, IL-8, IL-10, IL-17, TNFa, TNFß, VEGF-A, TGF-beta, S-RAGE, SP-A, SP-D, Angiopoétine 1 and KGF. | at Day 0, 7 and 14 | |
Secondary | Tregs 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. | at Day0, 5, 7, 11, 14 and Day28 | ||
Secondary | Tregs percentages 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. | at Day0, 5, 7, 11, 14 and Day28 | ||
Secondary | Deep Immunophenotyping of Cellular components in blood samples at Day 0, 7, and 14 | Cellular components will be analysed by flow cytometry covering (i) most of the innate and adaptive immune cells including Tregs, T helper cell subsets including follicular helper cells, B cell subsets, NK cell subsets, (ii) the associated relevant markers of activation/function/differentiation, tissue migration, as well as (iii) unconventional lymphoid cells (NKT/MAIT, innate lymphoid cells), myeloid-derived suppressor cells, classical and non-classical monocytes and dendritic cells (mDC1/2, pDC). | at Day0, 7 and Day14 | |
Secondary | T cell repertoire on Treg, after sorting from blood at Day 7 and Day 14 and compared to baseline | at Day0, 7 and Day14 | ||
Secondary | T cell repertoire on Teff (CD4 and CD8) after sorting from blood at Day 7 and Day 14 and compared to baseline | at Day0, 7 and Day14 | ||
Secondary | Single cells sequencing will be performed in BAL at Day 7 and Day 14 and compared to baseline. | at Day0, 7 and Day14 |
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