Phase 2b Clinical Trial to Evaluate the Tolerability and Efficacy in Reducing the Nasal Viral Load of SARS-CoV-2 of Benzalkonium Chloride 0.0065% (GX-03), in the Form of Nasal Ointment, in Patients Infected With COVID -19, and Evaluation of Its Tolerability in Health Care Providers, as a Preventive of Nasal Colonization, Complementary to Personal Protective Equipment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 3
- 主要终点
- Reduction of 60% in viral load from baseline
研究概览
简要总结
Phase 2b clinical trial to evaluate the safety and efficacy of intranasal application of GX-03 as a treatment and prevention for COVID-19.
详细描述
Phase 2b clinical trial to evaluate the safety and efficacy of intranasal application of GX-03 as a treatment and prevention for COVID-19. Patients hospitalized with a diagnosis of mild to moderate COVID-19 will be evaluated for a period of five days. Participating health care providers will be evaluated for a period of ten days. Swab samples will be collected from the right and left anterior nostrils at the beginning of the study, as well as three times per day in the treatment arm for five days. Swab samples will be collected from the right and left anterior nostrils at the beginning and end of the prevention arm. Samples will be subjected to biomolecular tests and viral cultures to assess positivity and disease progression. Safety will be evaluated through standard measures of erythema and edema in the nasal mucosa.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 hospitalized with SARS-CoV-2, diagnosed by a positive nasal or nasopharyngeal swab
- •Men or women who are not pregnant, not breastfeeding, postmenopausal, naturally or surgically sterile, or who agree to use effective contraception during the course of the study. A postmenopausal patient is defined as at least 12 12 months of natural spontaneous amenorrhea or at least 6 weeks after surgical menopause (bilateral oophorectomy).
- •Women of childbearing age who use one of the following acceptable contraceptive methods can be included in the study:
- •Surgical sterilization (hysterectomy and/or bilateral oophorectomy);
- •Surgical sterilization (surgical bilateral tubal ligation at least 6 weeks prior to screening); Intrauterine device (IUD) placed at least 3 months prior to detection; Abstinence (not having heterosexual sex);
- •Barrier method (condom or diaphragm) with spermicide for at least 14 days before selection and until completion of the study;
- •Stable hormonal contraceptive for at least 3 months prior to selection and until completion of the study
- •Patients capable of understanding and providing signed informed consent.
排除标准
- •SARS-CoV-2 positive patients on a ventilator.
- •Patients with any open wounds, injuries, inflammation, erythema, or infection (other than COVID-19) affecting the nasal passages, nose, upper lip, and the area of skin around the nose, including herpes simplex lesions.
- •Patients with a history of abnormal bleeding, bruising, frequent nosebleeds, or those diagnosed with von Willebrand disease.
- •Patients with nasal polyps or significant anatomical nasal abnormalities.
- •Patients with a history of nasal surgery, including cauterization, in the last 6 months.
- •Patients who currently have or have ever had a nose or septum piercing
- •Patients treated with antiviral medications in the past 7 days
- •Known allergy or history of significant adverse reactions to benzalkonium chloride or related compounds, or to any of the excipients.
- •Known or suspected pregnancy, pregnancy planned during the study period, or breastfeeding.
- •Clinically significant mental illness (to be determined by the investigator)
- •Recent history of (last 12 months) or strong potential for alcohol or substance abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz of beer, 5.0 oz of wine, or 1.5 oz of distilled spirits)
- •Exposure to any agents being researched within 30 days prior to admission to the study.
- •Prior enrollment in this study
- •If the patient has a condition that the investigator believes would interfere with their ability to give informed consent or comply with study instructions, or that could confuse the interpretation of study results or put the patient at undue risk.
研究组 & 干预措施
Treatment of hospitalized patients with laboratory-confirmed COVID-19
Hospitalized patients with laboratory-confirmed COVID-19 using GX-03 administered intranasally TID for 5 days.
干预措施: GX-03 (Drug)
Placebo Treatment of hospitalized patients with laboratory-confirmed COVID-19
Hospitalized patients with laboratory-confirmed COVID-19 using placebo (petrolatum emulsion) administered intranasally TID for 5 days.
干预措施: Petrolatum ointment (Drug)
Prevention of SARS-COV-2 in Health Care Providers
Health care providers with laboratory-confirmed negative COVID-19 using GX-03 administered intranasally TID for 10 days.
干预措施: GX-03 (Drug)
Placebo Prevention of SARS-COV-2 in Health Care Providers
Health care providers with laboratory-confirmed negative COVID-19 using placebo (petrolatum emulsion) administered intranasally TID for 10 days.
干预措施: Petrolatum ointment (Drug)
结局指标
主要结局
Reduction of 60% in viral load from baseline
时间窗: 5 days
Time to achieve a 60% reduction in viral load from baseline.
Primary Safety analysis
时间窗: 5-10 days
To evaluate the incidence rate(s) of non-serious and serious adverse events associated with administration of the study product.
次要结局
未报告次要终点