Ignite Creation Date:
2024-05-06 @ 2:34 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04357444
Status:
COMPLETED
Last Update Posted:
2021-10-04
First Post:
2020-04-10
Brief Title:
Low Dose of IL-2 In Acute Respiratory DistrEss Syndrome Related to COVID-19
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Low Dose of IL-2 In Acute Respiratory DistrEss Syndrome Related to COVID-19
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LILIADE-COVID
Brief Summary:
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
Detailed Description:
About 25 of hospitalized patients with SARS-CoV2 infection presented life-threatening respiratory conditions Of these 60 met ARDS criteria leading to death in 25 to 63 of the cases SARS-CoV2-related ARDS is caused by a massive inflammatory cell infiltration leading to dysregulated cytokinechemokine responses with lung immunopathological changes To date there is no treatment available
Regulatory T cells Treg are a subpopulation of CD4 T cells playing a crucial role in the control of immune responses in part by preventing excessive inflammation Depletion of Treg cells in models of lung infection or after berylium exposure exacerbated lung inflammation In contrast a beneficial role for Treg during early ARDS and its resolution has been observed
Low-dose interleukin 2 Ld-IL2 is the first therapy driving Treg-specific expansion and activation Ld-IL2 was successfully tested in a wide range of preclinical models of inflammatory diseases including beryllium-induced lung inflammation Moreover Ld-IL2 has been shown to be safe and free of serious adverse events when administered in patients with various autoimmune diseases Importantly in our previous work we observed only very low concentrations of IL-2 in the blood 01 pgmL 00-20 as well as in the BAL supernatant 08 pgmL 04-13 collected from patients during the early phase of ARDS suggesting that additional IL-2 could be beneficial for Treg expansionactivation
Our objective is therefore to investigate the therapeutic benefit of Ld-IL2 as a Treg inducer for controlling SARS-CoV2-related ARDS
After admission of patients to the intensive care unit at one of the recruiting centers the eligibility criteria will be checked by the investigating physician and participation in the study will be proposed to the patient or parentfamily membertrusted person If the patient is unable to consent and there is no parentfamily membertrusted person the patient may be included in the emergency procedure
After inclusion J0 the patient will be randomized to one of the 2 treatment arms low dose IL-2 or placebo
The experimental treatment will be daily administered to the patient from D1 to D10
The patient will be monitored daily until D28 during hospitalization
Regulatory T cells Treg are a subpopulation of CD4 T cells playing a crucial role in the control of immune responses in part by preventing excessive inflammation Depletion of Treg cells in models of lung infection or after berylium exposure exacerbated lung inflammation In contrast a beneficial role for Treg during early ARDS and its resolution has been observed
Low-dose interleukin 2 Ld-IL2 is the first therapy driving Treg-specific expansion and activation Ld-IL2 was successfully tested in a wide range of preclinical models of inflammatory diseases including beryllium-induced lung inflammation Moreover Ld-IL2 has been shown to be safe and free of serious adverse events when administered in patients with various autoimmune diseases Importantly in our previous work we observed only very low concentrations of IL-2 in the blood 01 pgmL 00-20 as well as in the BAL supernatant 08 pgmL 04-13 collected from patients during the early phase of ARDS suggesting that additional IL-2 could be beneficial for Treg expansionactivation
Our objective is therefore to investigate the therapeutic benefit of Ld-IL2 as a Treg inducer for controlling SARS-CoV2-related ARDS
After admission of patients to the intensive care unit at one of the recruiting centers the eligibility criteria will be checked by the investigating physician and participation in the study will be proposed to the patient or parentfamily membertrusted person If the patient is unable to consent and there is no parentfamily membertrusted person the patient may be included in the emergency procedure
After inclusion J0 the patient will be randomized to one of the 2 treatment arms low dose IL-2 or placebo
The experimental treatment will be daily administered to the patient from D1 to D10
The patient will be monitored daily until D28 during hospitalization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-001571-32 | EUDRACT_NUMBER | None | None |