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

NCT04501796 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: NIT-116 (SPESELPIS)
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to approximately 30 days

Secondary Outcomes (1)

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

  Up to approximately 30 days

Study Arms (2)

NT-I7

EXPERIMENTAL

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.

Drug: Double-Blind NT-I7

Placebo

PLACEBO COMPARATOR

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.

Drug: Double-Blind Placebo

Interventions

Double-Blind NT-I7 DRUG

Administered by intramuscular (IM) injection

Also known as: rhIL-7-hyFc, efineptakin alfa

NT-I7

Double-Blind Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NeoImmuneTech: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• University of Nebraska: collaborator

Study Sites (2)

Nih/Niaid

Bethesda, Maryland, 20892, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

efineptakin alfa

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 6, 2020
• Study Start: November 27, 2020
• Primary Completion: July 21, 2021
• Study Completion: February 23, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)