Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04498325
Status:
WITHDRAWN
Last Update Posted:
2021-08-05
First Post:
2020-07-30
Brief Title:
Evaluating the Effect of NT-I7 a Long Acting Interleukin-7 to Increase Lymphocyte Counts and Enhance Immune Clearance of SARS-CoV-2 COVID-19
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Phase I and Pilot Study Evaluating the Effect of NT-I7 a Long Acting Interleukin-7 to Increase Lymphocyte Counts and Enhance Immune Clearance of SARS-CoV-2
Status:
WITHDRAWN
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal investigator is leaving the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lymphopenia is common in patients with COVID-19 and is associated with worse clinical outcomes NT-I7 is a long-acting human interleukin-7 IL-7 that has been shown to increase absolute lymphocyte count ALC and CD4 and CD8 T cell counts with a well-tolerated safety profile in humans In this study patients who have tested positive for SARS-CoV-2 by PCR testing without severe disease and with ALC 1500 cellsmm3 will be enrolled
Detailed Description:
None
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