NCT04501796

A Trial of NT-I7 in COVID-19 (SPESELPIS)

A Double-blind, Randomized, Placebo-controlled, Phase 1, Single-dose, Dose-escalating Trial of Long-acting Recombinant Human IL-7 (NT-I7) for COVID-19

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: NeoImmuneTech · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main purposes of this study is to determine the following in participants with mild coronavirus disease 2019 (COVID-19): * Safety of a single dose of NT-I7 * The immunological effects of NT-I7 on peripheral lymphocyte counts in COVID-19 patients.

Detailed description

This is a multisite, double-blind, randomized, placebo-controlled, dose-escalating, phase 1 trial of NT-I7 with standard of care (SOC) versus placebo with SOC to evaluate the safety and efficacy of NT-I7 in adults with mild coronavirus disease 2019 (COVID-19). After determination of eligibility and baseline assessment, a single dose of the study agent (NT-I7 or placebo) will be administered after 1:1 randomization, along with SOC. Research blood collection will occur at baseline, days 3, 7, 14, 30, 60 and 90 days after administration. Primary and secondary evaluations will include assessment of adverse events (AEs), absolute lymphocyte count (ALC), and trajectory of other lymphocytes subsets: CD4, CD8, natural killer (NK), B, and mucosal-associated-invariant T (MAIT) cells. The final study visit will be at day 90 after the study agent administration. The investigators hypothesize that NT-I7 is safe for administration and preserves lymphocyte homeostasis in patients with mild COVID-19.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Double-Blind NT-I7	Administered by intramuscular (IM) injection
DRUG	Double-Blind Placebo	Placebo

Timeline

• Start date: 2020-11-27
• Primary completion: 2021-07-21
• Completion: 2023-02-23
• First posted: 2020-08-06
• Last updated: 2023-07-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study