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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NeoImmuneTech
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); University of Nebraska

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.