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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)
A Phase I and Pilot Study Evaluating the Effect of NT-I7, a Long Acting Interleukin-7, to Increase Lymphocyte Counts and Enhance Immune Clearance of SARS-CoV-2
1 other identifier
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
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Started Jul 2021
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2020
CompletedFirst Posted
Study publicly available on registry
August 4, 2020
CompletedStudy Start
First participant enrolled
July 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedAugust 5, 2021
July 1, 2021
9 months
July 30, 2020
July 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safe and tolerable dose of NT-I7 (Phase I only)
* The safe tolerated dose is defined as the dose level immediately below the dose level at which 1 patient of a cohort of 3 patients experiences dose-limiting toxicity within 14 days after administration of NT-I7 * Dose limiting toxicities (DLT) are defined as: * A serious adverse event that is at least possibly related to NT-I7 * A grade 3 or higher adverse event that is at least possibly related to NT-I7 (excluding injection site swelling, irritation or discomfort) * A clinically significant lab abnormality that is at least possibly related to NT-I7
Completion of DLT assessment window of Phase I portion of study (estimated to be 8 months)
Percent change in absolute lymphocyte count (ALC)
From baseline to Day 14
Secondary Outcomes (8)
Percent change in absolute lymphocyte count (ALC)
From baseline through Day 21
Change in SARS-CoV-2 viral load
From baseline to Day 7
Change in SARS-CoV-2 viral load
From baseline to Day 14
COVID-19 Symptom severity as measured by WHO Ordinal Scale for clinical improvement
From baseline, day 7, day 14, and day 21
Time to resolution of COVID-19 symptoms
From baseline through Day 21
- +3 more secondary outcomes
Study Arms (3)
NT-I7 (Phase I)
EXPERIMENTAL* In the phase I study, 3 dose levels of NT-I7 are planned. Dosing will be staggered such that there will be a minimum of 72 hours between the dosing of one participant and the dosing of the next participant * NT-I7 will be given by intramuscular injection on Day 0 * Participants will also be given standard of care treatment for COVID-19
NT-I7 (Pilot)
EXPERIMENTAL* NT-I7 (dose determined by Phase I portion of study) will be given by intramuscular injection on Day 0 * Participants will also be given standard of care treatment for COVID-19
Placebo (Pilot)
PLACEBO COMPARATOR* Placebo will be given by intramuscular injection on Day 0 * Participants will also be given standard of care treatment for COVID-19
Interventions
Prior to injection (Day 0), Day 7, and Day 14
-Phase I only: 1-2 hours prior to dosing, 6 hours after dosing, 24 hours after dosing, Day 7, Day 14, and Day 21
-Prior to study treatment, Day 4(optional), Day 7, and Day 14
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
Eligibility Criteria
You may qualify if:
- Tested PCR positive for SARS-CoV-2by nasopharyngeal swab, oropharyngeal swab, or saliva.
- Mild COVID-19, defined as WHO Ordinal Scale \<4 .
- Respiratory rate \< 20 bpm, HR \< 90 bpm, and SpO2 \> 93% on room air at sea level.
- Absolute lymphocyte count (ALC) \< 1500 cells/mm3 at the time of screening.
- AST/ALT ≤ 3.0 x ULN, total bilirubin ≤ 1.5 x ULN (except if due to Gilbert's syndrome).
- ≥ 18 years of age.
- First day of treatment must be no more than 10 days from onset of COVID-19 symptoms.
- Must be willing to be closely monitored in the hospital or in an alternate setting (e.g. clinical trial unit) for at least the first 7 days (±2 days allowed) following NT-I7/placebo injection.
- Individuals of reproductive potential must agree to either abstinence or use of at least one study-approved form of contraception when engaging in sexual activities that can result in pregnancy from the time of screening through 60 days for female and 120 days for male after study agent administration. Acceptable forms of contraception for this study are male or female condoms, diaphragms or cervical caps with a spermicide, or non-hormonal intrauterine devices.
- Patients with factors or concomitant illness associated with higher risk of mortality due to COVID-19 (such as older age, hypertension, diabetes, and/or COPD) are eligible.
- Able to understand and willing to sign an IRB approved written informed consent document.
You may not qualify if:
- Pregnant or breastfeeding women are excluded from this study because NT-I7 has not been evaluated regarding its potential for teratogenic or abortifacients effects. There is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug; therefore, breastfeeding should be discontinued if the mother is treated with NT-I7.
- Transferred from ICU to the floor.
- Requiring dialysis.
- Shortness of breath or known hypoxia (defined as PaO2/FiO2 ≤ 300 mmHg), or signs of serious lower airway disease.
- Evidence of ARDS, SIRS/shock, or cardiac failure.
- Elevated inflammatory markers such as CRP \> 2 x ULN, LDH \> 2 x ULN, D-dimer \> 2 x ULN, ferritin \> ULN, or IL-6 \> ULN (when available).
- Any established diagnosis of autoimmune disease requiring systemic treatment EXCEPT for vitiligo or endocrine disease (such as diabetes, thyroid disease, and adrenal disease) controlled by replacement therapy.
- Receipt of live attenuated vaccine within 30 days before the study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), Zoster, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- NeoImmuneTechcollaborator
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Campian, M.D., Ph.D.
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- The clinicians, participants, and clinical research coordinators will be blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2020
First Posted
August 4, 2020
Study Start
July 31, 2021
Primary Completion
April 30, 2022
Study Completion
April 30, 2022
Last Updated
August 5, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share