A Randomized, Placebo-Controlled Trial to Evaluate the Efficacy of Intranasal STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in viral load
研究概览
简要总结
This is a Phase 2 global, randomized, double-blind, placebo-controlled study designed to investigate the safety and preliminary efficacy of intranasal STI-9199 in adults and adolescents who are COVID-19 positive with mild to moderate symptoms.
详细描述
This is a Phase 2 global, randomized, double-blind, placebo-controlled study designed to investigate the safety and preliminary efficacy of intranasal STI-9199 in adults and adolescents who are COVID-19 positive with mild to moderate symptoms. This is a single dose study and three different dose concentrations will be compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Otherwise healthy, positive for COVID-19 by an EUA-approved rapid antigen or PCR test, has ongoing "mild to moderate illness or symptoms" with symptom onset starting < 5 days prior to screening visits
- •Must provide written informed consent/assent if a minor which includes signing the institutional review board/independent ethics committee approved consent form prior to participating in any study related activity
- •Willing and able to comply with study procedures and follow-up visits
- •Willing to follow all contraception guidelines
排除标准
- •In the Investigator's opinion, has progressive symptoms with likely imminent (24-48 hours) hospitalization or severe COVID-19 illness/symptoms
- •Any medical condition that, in the Investigator's or designee's opinion, could adversely impact participant safety or key objectives of the study
- •Has a prior history of long COVID
- •Has a clinically documents acute infection other than COVID-19
- •Known or suspected pregnancy, planned pregnancy, a positive pregnancy test at screening or are breastfeeding
- •Has participated, or is participating in a clinical reserach study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or IV immunoglobulin within 2 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
研究组 & 干预措施
STI-9199
4 mg, 10 mg or 20 mg STI-9199 administered intranasally
干预措施: STI-9199 (Drug)
Placebo
Placebo administered intranasally
干预措施: Placebo (Drug)
结局指标
主要结局
Change in viral load
时间窗: Baseline through Day 8
Change in viral load from baseline to Day 8 based on quantitative reverse-transcription polymerase chain reaction of COVID-19 virus from oropharyngeal swab collection
Incidence of adverse events (AEs) (safety)
时间窗: Baseline through study completion at up to 30 days
Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
次要结局
- Participant perceived disease progression(Baseline through Day 15)
- Rate of COVID-19-related medical visits(Baseline through Day 30)
- Change in viral load(Baseline through Day 11)
- Patient rated response(Baseline through D15)