A Trial of NT-I7 in COVID-19 (SPESELPIS)
NCT04501796 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2023-07-14
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.
Conditions
Interventions
- DRUG
-
Double-Blind NT-I7
Administered by intramuscular (IM) injection
- DRUG
-
Double-Blind Placebo
Placebo
Sponsors & Collaborators
-
National Institute of Allergy and Infectious Diseases (NIAID)
collaborator NIH -
University of Nebraska
collaborator OTHER -
NeoImmuneTech
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 19 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-27
- Primary Completion
- 2021-07-21
- Completion
- 2023-02-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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