- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04501796
A Trial of NT-I7 in COVID-19 (SPESELPIS)
July 13, 2023 updated by: NeoImmuneTech
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- Nih/Niaid
-
-
Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Individuals must meet all of the following criteria to be included in the study:
- Laboratory-confirmed SARS-CoV-2 infection as determined by either a documented positive molecular assay/ other commercial or public health assay in any specimen collected < 5 days prior to screening or a documented positive molecular assay ≥ 5 days prior to screening and confirmed by polymerase chain reaction (PCR) at screening.
- Illness of any duration with oxygen saturation > 93% at room air, heart rate ≤ 100 beats per minute at rest, and no evidence of respiratory distress with respiration rate < 20 breaths per minute.
- Able to provide informed consent.
- Aged ≥ 19 and ≤ 75 years.
- Absolute Lymphocyte Count <1,500 lymphocytes/µL.
- Avoid becoming pregnant or impregnate a partner through 90 days after study agent administration. Females must agree to 2 methods of contraception, and males to at least one method of contraception.
- Not participate in any other clinical trial for an investigational therapy through day 30.
Exclusion Criteria:
- Moderate to severe hypoxic respiratory failure requiring supplemental oxygen at rest, mechanical ventilation, ECMO, or any other noninvasive ventilation modality.
- CRP >15 mg/L or D-dimer > 0.75 µg/mL.
- Estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73m2, or requiring dialysis.
- AST/ALT > 3-times ULN, or total bilirubin > 1.5 times ULN (except if due to Gilbert's syndrome).
- Pregnancy or breastfeeding.
- Use of systemic corticosteroids or immunomodulant within 4 weeks prior to screening.
- Receipt of an investigational agent or investigational use of a licensed agent within 16 weeks prior to screening.
- HIV infection or underlying history of known or unknown primary or acquired immunodeficiency associated with lymphopenia and/or recurrent opportunistic infections.
- Autoimmune disease requiring systemic treatment EXCEPT for vitiligo or endocrine disease (such as diabetes, thyroid disease, and adrenal disease) controlled by replacement therapy.
- Malignancy requiring treatment 1 year prior to screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NT-I7
NT-I7 will be administered once by IM injection within 24 hours of baseline (day 0).
The treatment course pursued in all enrolled participants will be a single dose.
Dosing will be staggered with at least 72 hours between each study participant.
|
Administered by intramuscular (IM) injection
Other Names:
|
Placebo Comparator: Placebo
Placebo will be administered once by IM injection within 24 hours of baseline (day 0).
The treatment course pursued in all enrolled participants will be a single dose.
Dosing will be staggered with at least 72 hours between each study participant.
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the safety of a single dose of NT-I7 in a dose escalation fashion
Time Frame: Up to approximately 30 days
|
Assessment of the number and severity of AEs possibly, probably, or definitely related to study drug evaluated at 7 and 30 days.
|
Up to approximately 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the immunological effects of NT-I7 cumulatively for all doses on peripheral lymphocyte counts in COVID-19 patients.
Time Frame: Up to approximately 30 days
|
Assessment of the trajectory of ALC, CD4, CD8, NK, B, and MAIT cells measured at days 7, 14 and 30 after administration of NT-I7 or placebo compared to baseline values.
|
Up to approximately 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2020
Primary Completion (Actual)
July 21, 2021
Study Completion (Actual)
February 23, 2023
Study Registration Dates
First Submitted
July 27, 2020
First Submitted That Met QC Criteria
August 5, 2020
First Posted (Actual)
August 6, 2020
Study Record Updates
Last Update Posted (Actual)
July 14, 2023
Last Update Submitted That Met QC Criteria
July 13, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIT-116 (SPESELPIS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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