A Phase 2/3, Double-blind, Randomized, Placebo-controlled, 3-arm Study to Evaluate the Safety, and Efficacy of AD17002 (LTh[αK]) Intranasal Spray in Male and Female Participants Aged 18 to 65 Years With Mild to Moderate COVID 19
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Time to achieving the Patient Acceptable Symptom State (PASS)
研究概览
简要总结
AD17002 enhances nasal mucosal innate immunity and has met safety and efficacy endpoints in studies of nasal adjuvants or intranasal immunomodulators. This study aims to evaluate the safety and effectiveness of AD17002 in treating patients with mild to moderate COVID-19.
All participants will be randomly divided into 1:1:1 groups and will receive standard treatment. Additionally, participants will be given either a placebo, 20, or 40 μg of AD17002 via intranasal delivery, and clinical progress will be compared.
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
- •Aged ≥ 18 and ≤65 years old.
- •Laboratory confirmed SARS-CoV-2 infection, with first positive PCR test results within the past 48 hours of randomization.
- •Participants with COVID-19 symptoms within 5 days prior to the day of randomization, based on the following criteria: At least TWO of the following symptoms: Stuffy/runny nose, sore throat, shortness of breath, cough, low energy/tiredness, muscle/body aches, headache, chill/shivering, Fever (≥ 38ºC), nausea, vomiting, diarrhea, and loss of taste or smell.
- •Have a mild or moderate form of COVID-19 defined as:
- •respiratory rate ≤30 breaths per minute, heart rate ≤125 beats per minute; with saturation of oxygen (SpO2) ≥93% on room air at sea level No clinical signs listed in Inclusion Criteria #3 indicative of Severe Severity
- •Have a negative pregnancy test at Screening (for female participants of childbearing potential).
- •Participant or the participant's legal representative understands the study procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
- •Provide written informed consent for the study and willing to adhere to dose regimen and visit schedules.
排除标准
- •Participant has clinical signs suggestive of severe illnesses with SPO2≤
- •Sign of severe pneumonia as determined by treating physician on X-ray or SPO2
- •Participant has CT≥25 at screening
- •Participation in any other clinical study of an investigational agent treatment for SARS-CoV-2 infection within 30 days prior to the first IMP dosing.
- •Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 prior to PCR screening.
- •Participant with breakthrough SARS-CoV-2 infection within 2 weeks of SARS-CoV-2 vaccination.
- •History of severe renal disease (treatment with dialysis or phosphate binders) or clinically apparent hepatic impairment (e.g., jaundice, cholestasis, hepatic synthetic impairment, active hepatitis).
- •Impaired cardiac function or clinically significant cardiac diseases as judged by the Investigator.
- •History of anaphylaxis reaction to any known or unknown cause.
- •Immunosuppressed persons as result of illness (e.g., HIV infection) or treatment.
- •Documented history of Bell's palsy.
- •History of allergic reaction to kanamycin.
- •Immunosuppressive treatment within 3 months prior to the Screening Visit.
- •Intranasal medication or nasal topical treatment at the time of screen and study.
- •Assessed by the Investigator to be ineligible to participate in the study.
研究组 & 干预措施
Placebo Comparator
Participants will receive placebo (formulation buffer) on treatment days 1, 3 and 5.
干预措施: Placebo (Biological)
Low dose treatment group
Participants will receive 20 μg of AD17002 in formulation buffer on treatment days 1, 3 and 5.
干预措施: AD17002 + Formulation buffer (Biological)
High dose treatment group
Participants will receive 40 μg of AD17002 in formulation buffer on treatment days 1, 3 and 5.
干预措施: AD17002 + Formulation buffer (Biological)
结局指标
主要结局
Time to achieving the Patient Acceptable Symptom State (PASS)
时间窗: [Day 1 to Day 29]
Defined as the value of symptoms the patient considered to be well-being thresholds of the symptoms and function. The study incorporates the most widely used anchoring question to identify PASS cut-off points, which is: "Taking into account all your daily activities, do you consider your current state satisfactory in relation to pain level and functional impairment?" The response options were "Yes" or "No.
Time to disease improvement
时间窗: [Day 1 to Day 29]
Defined as time to achieving ≥1 decrease on WHO 11-point Clinical Progression Scale
次要结局
- Vital signs evaluation([Day 1 to Day 29])
- PASS evaluation([Day 1 to Day 29])
- Days of COVID-19 symptomatic hospitalization([Day 1 to Day 29])
- Oxygen supplement treatment([Day 1 to Day 29])
- Physical examination([Day 1 to Day 29])
- Symptom severity report([Day 1 to Day 29])
- Viral clearance([Day 1 to Day 29])
- Viral clearance rate by PCR([Day 1 to Day 29])
- Clinical Progression Scale analysis([Day 1 to Day 29])
- Clinical laboratory assessment([Day 1 to Day 29])
- Adverse events assessment([Day 1 to Day 29])
- Treatment-emergent adverse events assessment (TEAE)([Day 1 to Day 29])
- Proportion of COVID-19 symptomatic hospitalization([Day 1 to Day 29])
- Nasal tolerability examination([Day 1 to Day 29])
- Oxygen supplement treatment rate([Day 1 to Day 29])
- Symptom relieve days([Day 1 to Day 29])
- Mortality rate report([Day 1 to Day 29])