A Trial of NT-I7 in COVID-19 (SPESELPIS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04501796 |
Recruitment Status :
Recruiting
First Posted : August 6, 2020
Last Update Posted : August 6, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Drug: Double-Blind NT-I7 Drug: Double-Blind Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Double-Blind. |
Primary Purpose: | Treatment |
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 |
Estimated Study Start Date : | August 2020 |
Estimated Primary Completion Date : | October 2021 |
Estimated Study Completion Date : | December 2021 |
Arm | Intervention/treatment |
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Experimental: NT-I7
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.
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Drug: Double-Blind NT-I7
Administered by intramuscular (IM) injection
Other Names:
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Placebo Comparator: Placebo
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.
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Drug: Double-Blind Placebo
Placebo |
- Evaluate the safety of a single dose of NT-I7 in a dose escalation fashion [ Time Frame: Up to approximately 30 days ]Assessment of the number and severity of AEs possibly, probably, or definitely related to study drug evaluated at 7 and 30 days.
- Evaluate the immunological effects of NT-I7 cumulatively for all doses on peripheral lymphocyte counts in COVID-19 patients. [ Time Frame: Up to approximately 30 days ]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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 ≥ 18 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, 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04501796
Contact: Anela Kellogg | 240-669-2877 | anela.kellogg@nih.gov | |
Contact: Megan Anderson | 301-761-7323 | megan.anderson2@nih.gov |
United States, Maryland | |
Nih/Niaid | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: Anela Kellogg 240-669-2877 anela.kellogg@nih.gov | |
United States, Nebraska | |
University of Nebraska Medical Center | Not yet recruiting |
Omaha, Nebraska, United States, 68198 | |
Contact: Amy Haberman 402-559-5955 |
Responsible Party: | NeoImmuneTech |
ClinicalTrials.gov Identifier: | NCT04501796 |
Other Study ID Numbers: |
NIT-116 (SPESELPIS) |
First Posted: | August 6, 2020 Key Record Dates |
Last Update Posted: | August 6, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
NT-I7 (efineptakin alfa, rhIL-7-hyFc) COVID-19 |