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)

PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

July 31, 2021

Primary Completion Date

April 30, 2022

Study Completion Date

April 30, 2022

Conditions
COVID-19SARS-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 (1)

All Listed Sponsors
collaborator

NeoImmuneTech

INDUSTRY

lead

Washington University School of Medicine

OTHER

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) | Biotech Hunter | Biotech Hunter