Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-31 @ 9:30 PM
Study NCT ID:
NCT04927169
Status:
TERMINATED
Last Update Posted:
2024-04-12
First Post:
2021-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection (Brazil Cohort)
Sponsor:
Revimmune
Organization:
Study Overview
Official Title:
Recombinant Human InterLeukin-7 (CYT107) to Improve Clinical Outcomes in Lymphopenic PAtients With COVID-19 Infection - "ILIAD 7 Trial" Brazil Cohort
Status:
TERMINATED
Status Verified Date:
2024-04
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-BRA
Brief Summary:
Comparison of the effects of CYT107 vs Placebo administered by intra-muscular route (IM) at 10μg/kg twice a week for three weeks on immune reconstitution of lymphopenic COVID-19 patients
Detailed Description:
Approximately forty-eight (48) participants will be randomized 1:1 to receive
(a) Intramuscular (IM) administration of CYT107 at 10 μg/kg followed, after 72hrs of observation, by 10 μg/kg twice a week for 3 weeks (maximum 7administrations adjusted to patient's length of stay in the hospital) or (b)Intramuscular (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 μg/kg followed, after 72hrs of observation, by 10 μg/kg twice a week for 3 weeks (maximum 7administrations adjusted to patient's length of stay in the hospital) or (b)Intramuscular (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:
True
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?:
True
Is an FDA AA801 Violation?: