A Novel Nasal Treatment for COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in SARS-CoV-2 Levels
研究概览
简要总结
The goal of this study is to test an investigational new inhaled medication called Optate.
详细描述
The goal of this study is to test an investigational new inhaled medication called Optate. Investigational means it has not been approved by the Food and Drug Administration (FDA) for this use. The investigators hypothesize that Optate will reduce the length of symptoms and disease severity in patients with COVID-19 (Coronavirus disease of 2019) through inhibition of SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) viral replication within the upper and lower airways. Testing this hypothesis is important because treatments for COVID-19 are needed alongside vaccines. COVID-19 begins in the nasal passages, so targeted therapies to the nasal passages at early stages of the disease may prevent severe disease from occurring.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Providing pharmacy will randomize doses and provide blinded doses
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COVID-19 PARTICIPANTS Inclusion Criteria: Subjects, 18 and above, with mild COVID-19 upper respiratory tract infection symptoms
- •positive rapid COVID-19 test
- •Ordinal Scale for Clinical Improvement < 3 (OSCI, Appendix 2) and/or
- •Fever > 100 degree F and/or
- •Nasal congestion
排除标准
- •FEV1 (Forced Exhaled Volume) < 55% predicted on the day of study procedures
- •OSCI ≥ 3 (Objective Structured Clinical Exam)
- •Pregnancy
- •Inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication
- •HEALTHY CONTROLS Inclusion Criteria: Subjects, 18 and above, without mild COVID-19 upper respiratory tract infection symptoms
- •negative rapid COVID-19 test
- •No known medical problems or taking any medication that, in the investigator's opinion, would make them unsuitable for participation.
- •Exclusion Criteria:
- •Pregnancy
- •Inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication
研究组 & 干预措施
Participants with COVID-19:Treatment
Participants with COVID-19:Treatment - subjects on this treatment arm will receive study drug
干预措施: Optate (Drug)
Participants with COVID-19: Placebo
Participants with COVID-19: Placebo - subjects on this arm will get placebo
干预措施: Placebo (Drug)
Healthy Controls: Treatment
Healthy Controls: Treatment - subjects on this treatment arm will receive study drug
干预措施: Optate (Drug)
Healthy Controls: Placebo
Healthy Controls: Placebo - subjects on this arm will get placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in SARS-CoV-2 Levels
时间窗: Immediately before and one-hour after treatment
SARS-CoV-2 levels will be measured in nasal wash before and one hour after Optate or placebo administration
Change in SNOT-22 score
时间窗: Immediately before and 24-hours after treatment
SNOT-22 scores (a validated, 22-item quality of life instrument survey) will be assessed immediately prior to Optate or placebo administration. The SNOT-22 assesses five domains (nasal, ear/facial, sleep, function and emotion) on a Likert scale from 0-5, where 0 means no problems and 5 means the worst possible problems. The total score ranges from 0-110, with higher scores indicating more severe symptoms. Scores will be reassessed 24 hours after administration.
次要结局
- Change in SARS-CoV-2 Levels(Immediately before and one-hour after treatment)
- Change in nasal pH(Immediately before, immediately after and one-hour after treatment)
- Change in SARS-CoV-2 Levels(Immediately before and one-hour after treatment)
研究者
James F. Chmiel
Professor of Pediatrics
Indiana University