Status:
TERMINATED
A Trial of NT-I7 in COVID-19 (SPESELPIS)
Lead Sponsor:
NeoImmuneTech
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
University of Nebraska
Conditions:
COVID-19
Eligibility:
All Genders
19-75 years
Phase:
PHASE1
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...
Detailed Description
This is a multisite, double-blind, randomized, placebo-controlled, dose-escalating, phase 1 trial of NT-I7 with standard of care (SOC) versus placebo with SOC to evaluate the safety and efficacy of NT...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04501796
Start Date
November 27 2020
End Date
February 23 2023
Last Update
July 14 2023
Active Locations (2)
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1
Nih/Niaid
Bethesda, Maryland, United States, 20892
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198