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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04501796

Run by

NeoImmuneTech

People needed

7

Starts

2020-11-27

Expected to finish

2023-02-23

Last updated by the study team

2023-07-14

Who can join

Age: 19 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Nih/Niaid — Bethesda, Maryland, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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