NCT05768113已完成不适用
A Randomized, Double-blind, Multi-center Study to Evaluate the Efficacy and Safety of Ethyl Lauroyl Arginate Hydrochloride (LAEH) Formulation Versus a Matching Placebo Formulation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Enumerating viral load using RT-PCR test.
研究概览
简要总结
The Covixyl-V LAEH Nasal Spray's safety and efficay is clinically tested for use in subjects with COVID-19 infection.
A randomized, double-blind, multi-center study is conducted to evaluate the efficacy and safety of ethyl lauroyl arginate hydrochloride (LAEH) formulation versus a matching placebo formulation administered as a nasal spray to reduce viral load from nasal area of subjects with coronavirus disease 2019 (COVID-19).
详细描述
The primary endpoint for this study was the comparison of change in viral load in RT-PCR Test.
Proportion of COVID-19 infection-free subjects between the two treatment arms was followed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent or, by his or her legal/authorized representatives when the subject is not capable of giving consent, prior to initiation of any study procedures
- •Male or female of ≥18 years and ≤65 years of age (inclusive) at time of enrollment
- •Subjects with laboratory-confirmed diagnosis of COVID-19 at the time of screening (Day -3 to 0) using RT PCR method.
- •Subject with mild COVID-19 symptoms (e.g., fever, cough, sore throat, headache, muscle pain, nasal congestion, rhinorrhea, loss of smell and taste) but who did not have shortness of breath or dyspnea
- •Subjects who did not require hospitalization
- •Subjects with SpO2 levels ≥ 95%
- •Viral load by RT-PCR between 3.3 × 106 copies/mL to 6.6 × 106 copies/mL
- •Female subject who was not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile
- •Female subject of childbearing potential who had negative urine pregnancy test.
排除标准
- •Allergy to LAEH or any of the excipients of the formulation
- •History of allergies or flu within 30 days prior to the day of enrollment
- •Sensitivity to nostril skin or irritation or bleeding history within 30 days prior to the day of enrollment
- •Females who were breast-feeding, lactating, pregnant or intending to become pregnant
- •COVID-19 subjects with moderate, severe or critical illness or requiring intensive care or mechanical ventilation
- •History of severe respiratory disease and requirement for long-term oxygen therapy
- •Had received antibiotic/s, antiviral drug, and hormonal drugs within 30 days prior to the day of enrollment
- •Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator
- •Had received or had a plan to receive a SARS-CoV-2 vaccine during the study period
- •Participated in any interventional drug or medical device trials within 30 days prior to the day of enrollment.
结局指标
主要结局
Enumerating viral load using RT-PCR test.
时间窗: 6days
Comparison of change in viral load from baseline between the two treatment arms
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
撤回
3 期
A Study to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 InfectionCovid19NCT04858620Larkin Community Hospital
已完成
3 期
Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)Rhinitis, Allergic, PerennialNCT01134705Teva Branded Pharmaceutical Products R&D, Inc.474
已完成
3 期
Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)Seasonal Allergic RhinitisHay FeverNCT01024608Teva Branded Pharmaceutical Products R&D, Inc.340
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