A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Viral load change from baseline to D8
研究概览
简要总结
This is a double-blind study designed to investigate the efficacy, safety and PK of a single dose of COVI-DROPS or matched placebo in outpatient adults who have tested positive for COVID-19 and are either asymptomatic or have mild symptoms.
详细描述
Subjects will be randomized 2:2:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS 20 mg or matched placebo in a double-blind manner. Investigational product (COVI-DROPS or matched placebo) will be administered once as two separate 0.5 mL instillations (0.5 mL up each nostril). Subjects will be followed to Day 60.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive for COVID-19 with any locally approved RT-PCR within 7 days of planned treatment.
- •Either have no COVID-19 symptoms (asymptomatic) or mild illness/symptoms
- •Must be willing and able to comply with all planned study procedures and be available for all in-person and telephonic study visits and follow-up as required per protocol
- •Subject must have provided written informed consent
- •Willing to follow contraception guidelines
排除标准
- •Moderate or severe illness/symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours)
- •Any medical condition that, in the Investigator's opinion, could adversely impact subject safety or key objectives of the study, including any intranasal pathology, or clinically significant laboratory abnormalities, or active clinical disease process
- •Documented acute infection other thand COVID-19
- •Pregnant or lactating women who are breast feeding or planning to during the study
- •Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 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
COVI-DROPS
10 mg or 20 mg of COVI-DROPS administered intranasally
干预措施: COVI-DROPS (Biological)
Placebo
1 mL administered intranasally
干预措施: Placebo (Drug)
结局指标
主要结局
Viral load change from baseline to D8
时间窗: Baseline to Day 8
Viral load change from baseline to D8, based on reverse-transcriptase polymerase chain reaction (RT-PCR) determined COVID-19 viral titres (Log-10 copies/mL) from nasopharyngeal swabs
次要结局
- Change in patient-reported COVID-19 symptoms(Baseline to Day 8 and Day 29)
- Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29(Baseline through Day 29)
- Worst WHO Clinical Progression Scale score up to D8 and from D9 to D29(Baseline through Day 29)
- Viral load change from baseline to D29 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL) from nasopharyngeal swabs(Baseline to Day 29)
- The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations through D29(Baseline through Day 29)
- Change in WHO Clinical Progression Scale score(Baseline to Day 8 and Day 29)