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
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Evaluate the safety of a single dose of NT-I7 in a dose escalation fashion
研究概览
简要总结
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.
详细描述
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-I7 in adults with mild coronavirus disease 2019 (COVID-19). After determination of eligibility and baseline assessment, a single dose of the study agent (NT-I7 or placebo) will be administered after 1:1 randomization, along with SOC. Research blood collection will occur at baseline, days 3, 7, 14, 30, 60 and 90 days after administration. Primary and secondary evaluations will include assessment of adverse events (AEs), absolute lymphocyte count (ALC), and trajectory of other lymphocytes subsets: CD4, CD8, natural killer (NK), B, and mucosal-associated-invariant T (MAIT) cells. The final study visit will be at day 90 after the study agent administration. The investigators hypothesize that NT-I7 is safe for administration and preserves lymphocyte homeostasis in patients with mild COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-Blind.
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Double-Blind NT-I7 (Drug)
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.
干预措施: Double-Blind Placebo (Drug)
结局指标
主要结局
Evaluate the safety of a single dose of NT-I7 in a dose escalation fashion
时间窗: 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.
次要结局
- Evaluate the immunological effects of NT-I7 cumulatively for all doses on peripheral lymphocyte counts in COVID-19 patients.(Up to approximately 30 days)