NCT04498325

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)

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• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 cells/mm3 will be enrolled.

Conditions

• COVID-19
• SARS-CoV-2

Interventions

Type	Name	Description
DRUG	NT-I7	Supplied by study
DRUG	Placebo	Supplied by study
PROCEDURE	Blood for research purposes	Prior to injection (Day 0), Day 7, and Day 14
PROCEDURE	Blood for pharmacokinetic samples	-Phase I only: 1-2 hours prior to dosing, 6 hours after dosing, 24 hours after dosing, Day 7, Day 14, and Day 21
PROCEDURE	Nasopharyngeal, oropharyngeal, or saliva swab	-Prior to study treatment, Day 4(optional), Day 7, and Day 14
PROCEDURE	Blood for anti-drug antibody (ADA)	Baseline, Day 7, Day 14, Day 21, Day 60, and Day 90. Participants with ADA positivity on Day 90 will be monitored every 90 days until antibody level returns to baseline

Timeline

• Start date: 2021-07-31
• Primary completion: 2022-04-30
• Completion: 2022-04-30
• First posted: 2020-08-04
• Last updated: 2021-08-05

Regulatory

• FDA-regulated drug study