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COVID-19Phase 1NCT04498325

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 1 study testing NT-I7, Blood for research purposes and Blood for pharmacokinetic samples in people with COVID-19 and SARS-CoV-2, run by Washington University School of Medicine.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19, SARS-CoV-2
What is being tested?
NT-I7, Blood for research purposes and Blood for pharmacokinetic samples
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
31 Jul 2021to 30 Apr 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • Receiving any other investigational agents which may affect patient's lymphocyte counts. Note: There is no evidence that chloroquine or hydroxychloroquine could affect lymphocyte counts. Thus, chloroquine or hydroxychloroquine use is not an exclusion criteria for this study. Additionally, it is permissible for potential participants to have received investigational or off-label agents for COVID-19 prior to or during study participation.
  • 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.
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  • 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.

About this study

Official title: 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

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.

Conditions
COVID-19, SARS-CoV-2
Being tested
NT-I7, Placebo, Blood for research purposes, Blood for pharmacokinetic samples, Nasopharyngeal, oropharyngeal, or saliva swab
Keywords
COVID-19, SARS-CoV-2
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NT-I7Drug

    Supplied by study

  • PlaceboDrug

    Supplied by study

  • Blood for research purposesProcedure or surgery

    Prior to injection (Day 0), Day 7, and Day 14

  • Blood for pharmacokinetic samplesProcedure or surgery

    -Phase I only: 1-2 hours prior to dosing, 6 hours after dosing, 24 hours after dosing, Day 7, Day 14, and Day 21

  • Nasopharyngeal, oropharyngeal, or saliva swabProcedure or surgery

    -Prior to study treatment, Day 4(optional), Day 7, and Day 14

  • Blood for anti-drug antibody (ADA)Procedure or surgery

    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

Study groups in NCT04498325
Study groupRoleWhat they receive
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
Receives: Drug: NT-I7; Procedure: Blood for research purposes; Procedure: Blood for pharmacokinetic samples; Procedure: Nasopharyngeal, oropharyngeal, or saliva swab; Procedure: Blood for anti-drug antibody (ADA)
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
Receives: Drug: NT-I7; Procedure: Blood for research purposes; Procedure: Nasopharyngeal, oropharyngeal, or saliva swab; Procedure: Blood for anti-drug antibody (ADA)
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
Receives: Drug: Placebo; Procedure: Blood for research purposes; Procedure: Nasopharyngeal, oropharyngeal, or saliva swab; Procedure: Blood for anti-drug antibody (ADA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Completion of DLT assessment window of Phase I portion of study (estimated to be 8 months)

  2. Percent change in absolute lymphocyte count (ALC)

    Measured: From baseline to Day 14

Secondary outcomes (8)

  1. Percent change in absolute lymphocyte count (ALC)

    Measured: From baseline through Day 21

  2. Change in SARS-CoV-2 viral load

    -Using PCR from nasopharyngeal swab, oropharyngeal swab or saliva

    Measured: From baseline to Day 7

  3. Change in SARS-CoV-2 viral load

    -Using PCR from nasopharyngeal swab, oropharyngeal swab or saliva

    Measured: From baseline to Day 14

  4. COVID-19 Symptom severity as measured by WHO Ordinal Scale for clinical improvement

    Measured: From baseline, day 7, day 14, and day 21

  5. Time to resolution of COVID-19 symptoms

    Measured: From baseline through Day 21

  6. Incidence of treatment-emergent adverse events

    -A treatment emergent adverse event (TEAE) is defined as any event that begins or worsens on or after date of first dose of study treatment.

    Measured: From baseline through Day 21

  7. Number of participants by PCR result status (positive or negative)

    -If quantitative PCR is not available

    Measured: -From baseline to Day 7

  8. Number of participants by PCR result status (positive or negative)

    -If quantitative PCR is not available

    Measured: From baseline to Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2020
  2. Study start31 Jul 2021 (estimated)
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion30 Apr 2022 (estimated)

Why it stopped: Principal investigator is leaving the institution.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will open as a phase I study to test three different dose levels of NT-I7. Once a safe tolerated dose is established, the pilot portion of the study will be activated wherein participants will be randomized on a 1:1 basis to receive a single injection of NT-I7 (at the safe tolerated dose) or placebo.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04498325
Sponsor's protocol ID
202009065
Status last verified
Jul 2021
First submitted
30 Jul 2020
Last updated
5 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NT-I7, Blood for research purposes and Blood for pharmacokinetic samples in people with COVID-19 and SARS-CoV-2, run by Washington University School of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safe and tolerable dose of NT-I7 (Phase I only) (time frame: Completion of DLT assessment window of Phase I portion of study (estimated to be 8 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04498325.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.

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