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

NIT-116 (SPESELPIS)

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.

2020-11-27

2021-07-21

2023-02-23

Terminated

Early phase I

7

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.

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2023-07-14