NCT04932915终止2 期
A Randomized Placebo-controlled Phase 2 Study to Assess the Safety and Efficacy of UNI91103 Intranasal Administration in Adults With Asymptomatic or Mildly Symptomatic COVID-19
UNION therapeutics3 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2021年9月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- Proportion of subjects with worsened symptoms any time from Day 3 to Day 10 compared with baseline
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of UNI91103 intranasal spray for treatment of coronavirus disease 2019 (COVID-19) in asymptomatic or mildly symptomatic adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or female aged ≥45 and <80 years
- •Subject is tested to confirm infection with SARS-CoV-2 on a sample taken within 3 days before randomization
- •Subject is either without symptoms or has 1 or more of the following symptoms: Stuffy or runny nose, Sore throat, Loss of taste, Loss of smell, Headache.
- •None of the symptoms should have been present >5 days.
排除标准
- •Subject has an underlying condition that may interfere with intranasal administration of the IMP (e.g., chronic ulcers in the nose).
- •Subject has symptoms suggesting engagement of the lower respiratory tract or a systemic engagement
- •Subject has an active or acute infection other than SARS-CoV-2
- •Subject has another member of the same household recruited to this study
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo intranasal spray, BID, 10 consecutive days
干预措施: Placebo (Drug)
UNI91103 intranasal spray 1%
Experimental
UNI91103 intranasal spray 1%, BID, 10 consecutive days
干预措施: Niclosamide (Drug)
结局指标
主要结局
Proportion of subjects with worsened symptoms any time from Day 3 to Day 10 compared with baseline
时间窗: Day 3 to Day 10
Worsening is assessed by the Food and Drug Administration (FDA) COVID-19 Symptom Questionnaire, assessing severity of symptoms over the past 24 hour period.
次要结局
- Proportion of subjects with worst intensity/grade up to Day 10 and up to Day 15 in any single symptoms in the 3 domains of the FDA COVID-19 questionnaire(Day 10 and up to Day 15)
- Proportion of subjects reporting the following number of symptoms with worst intensity/severe grade: ≥ 1 symptom, ≥ 2 symptoms, ≥ 3 symptoms, etc.(Any time point)
- Proportion of subjects with worsened symptoms at Day 15 compared with baseline.(Day 15)
- Change from baseline in each single symptom score(Days 10, 15 and 30)
- Proportion of subjects who are asymptomatic on Day 10(Day 10)
- Proportion of subjects requiring visits to urgent care (UC) or emergency department (ED) facilities, or hospitalization because of signs or symptoms of COVID-19(Day 10, 15 and 30)
- Proportion of subjects admitted to intensive care units (ICU) and/or died(At screening, Day 1, and every other day through Day 10, and again at Day 15 and Day 30)
- Change from baseline in SARS-CoV-2 viral load at Day 5 and Day 10(Day 5 and Day 10)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
3 期
Study In Adults And Adolescents With Seasonal Allergic RhinitisHayfeverRhinitis, Allergic, SeasonalSeasonal Allergic RhinitisNCT00115622GlaxoSmithKline304
已完成
2 期
7 Day Study of Mast Cell Inhibitor, R926112, in Patients With Symptomatic Seasonal Allergic RhinitisRhinitis, Allergic, SeasonalNCT00115089Rigel Pharmaceuticals375
撤回
1 期
Clinical Trial of the Use of the Nasal Spray of Patients With Recurrence of GlioblastomaGliosarcomaAnaplastic GliomasRecurrent GlioblastomaNCT03275558Center Trials & Treatment
已完成
2 期
Acute Treatment Trial in Adult Subjects With MigrainesMigraineNCT03872453Pfizer2,154
已完成
1 期
A Study of NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the FaceEnlarged PoresSebum ProductionNCT05784363Merz North America, Inc.31