Efficacy, Safety, and Tolerability of GLS-1200 Topical Nasal Spray in the Prevention of Incident Confirmed, Symptomatic SARS-CoV-2 Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 184
- 试验地点
- 3
- 主要终点
- Number Serious Adverse Events as Assessed by CTCAE v5.0
研究概览
简要总结
This clinical trial will evaluate the safety, tolerability and effectiveness of topical GLS-1200 nasal spray to reduce the incidence of confirmed, symptomatic SARS-CoV-2 infection.
详细描述
This Phase II randomized, placebo-controlled, double-blind study will assess whether topical GLS-1200 applied via nasal spray atomizer is well-tolerated and can reduce the incidence of confirmed SARS-CoV-2 infection. Subjects will be randomized to either the GLS-1200 or placebo group in a 2:1 ratio with a target enrollment of 225 subjects. Subjects will self-administer study drug three times daily for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •Able to provide informed consent
- •Able and willing to comply with study procedures
- •Able and willing to utilize an approved form of pregnancy prevention for women of child bearing potential through to the end of treatment
排除标准
- •Know allergy to quinine, quinidine, or mefloquine
- •Confirmed prior positive test for SARS-CoV-2
- •Treatment within the past 2 weeks with chloroquine, hydroxychloroquine, or remdesivir
- •Pregnancy or documentation of pregnancy by pre-treatment urine test or breast feeding or plans to become pregnant during the course of the study
研究组 & 干预措施
GLS-1200
1 mL of GLS-1200 per nostril, TID
干预措施: GLS-1200 (Drug)
0.9 %Saline
1 mL of 0.9% Saline per nostril, TID
干预措施: Placebo (Drug)
结局指标
主要结局
Number Serious Adverse Events as Assessed by CTCAE v5.0
时间窗: Through 4 weeks of treatment
Incidence of SARS-CoV-2 Infection, Confirmed by PCR Relative to Treatment Group
时间窗: Through 4 weeks of treatment
次要结局
未报告次要终点