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)

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

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

Sponsors & Collaborators

• NeoImmuneTech

  collaborator INDUSTRY

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Jian Campian, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-31

Primary Completion

2022-04-30

Completion

2022-04-30

FDA Drug

Yes