Ignite Creation Date:
2024-05-06 @ 2:52 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04442178
Status:
TERMINATED
Last Update Posted:
2022-04-08
First Post:
2020-06-19
Brief Title:
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection ILIAD-7-US-I
Sponsor:
Revimmune
Organization:
Revimmune
Study Overview
Official Title:
A Multicenter Randomized Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 CYT107 for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection US Infectious Cohort
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
POOR ACCRUAL
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ILIAD-7-US-I
Brief Summary:
Comparison of the effects of CYT107 vs Placebo administered IM at 10μgkg twice a week for three weeks on immune reconstitution of lymphopenic COVID-19 patients
Detailed Description:
Approximately forty-eight 48 participants will be randomized 11 to receive
a Intramuscular IM administration of CYT107 at 10 μgkg followed after 72hrs of observation by 10 μgkg twice a week for 3 weeks maximum 7administrations adjusted to patients length of stay in the hospital or bIntramuscular IM placebo normal saline at the same frequency The aim of the study is to test the ability of CYT107 to produce an immune reconstitution of these patients and observe possible association with a clinical improvement
This cohort excludes oncology patients on treatment
a Intramuscular IM administration of CYT107 at 10 μgkg followed after 72hrs of observation by 10 μgkg twice a week for 3 weeks maximum 7administrations adjusted to patients length of stay in the hospital or bIntramuscular IM placebo normal saline at the same frequency The aim of the study is to test the ability of CYT107 to produce an immune reconstitution of these patients and observe possible association with a clinical improvement
This cohort excludes oncology patients on treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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