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A Trial of NT-I7 in COVID-19 (SPESELPIS)

Primary Purpose

COVID-19

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Double-Blind NT-I7

Double-Blind Placebo

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring NT-I7 (efineptakin alfa, rhIL-7-hyFc), COVID-19

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Nih/Niaid
University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NT-I7

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Evaluate the safety of a single dose of NT-I7 in a dose escalation fashion

Assessment of the number and severity of AEs possibly, probably, or definitely related to study drug evaluated at 7 and 30 days.

Secondary Outcome Measures

Evaluate the immunological effects of NT-I7 cumulatively for all doses on peripheral lymphocyte counts in COVID-19 patients.

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.

Full Information

NCT ID

NCT04501796

First Posted

July 27, 2020

Last Updated

July 13, 2023

Sponsor

NeoImmuneTech

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID), University of Nebraska

1. Study Identification

Unique Protocol Identification Number

NCT04501796

Brief Title

A Trial of NT-I7 in COVID-19 (SPESELPIS)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Terminated

Why Stopped

Study was halted due to lack of patient population resulting in slow enrollment.

Study Start Date

November 27, 2020 (Actual)

Primary Completion Date

July 21, 2021 (Actual)

Study Completion Date

February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NeoImmuneTech

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID), University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

NT-I7 (efineptakin alfa, rhIL-7-hyFc), COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double-Blind.

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NT-I7

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Double-Blind NT-I7

Other Intervention Name(s)

rhIL-7-hyFc, efineptakin alfa

Intervention Description

Administered by intramuscular (IM) injection

Intervention Type

Drug

Intervention Name(s)

Double-Blind Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Evaluate the safety of a single dose of NT-I7 in a dose escalation fashion

Description

Assessment of the number and severity of AEs possibly, probably, or definitely related to study drug evaluated at 7 and 30 days.

Time Frame

Up to approximately 30 days

Secondary Outcome Measure Information:

Title

Evaluate the immunological effects of NT-I7 cumulatively for all doses on peripheral lymphocyte counts in COVID-19 patients.

Description

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.

Time Frame

Up to approximately 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Nih/Niaid

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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A Trial of NT-I7 in COVID-19 (SPESELPIS)

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