NCT05787418Enrolling By Invitation3 期
A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of HH-120 Nasal Spray for Post-exposure Prophylaxis of SARS-CoV-2
Huahui Health2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2023年3月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- The incidence of symptomatic SARS-CoV-2 infection
研究概览
简要总结
This study will assess the efficacy of HH-120 nasal spray in participants for the post-exposure prevention of SARS-CoV-2.
详细描述
During this study, participants will receive HH-120 nasal spray treatment for 7 consecutive days, the efficacy and safety of HH-120 nasal spray will be assessed throughout the study period mainly based on the incidence of symptomatic SARS-CoV-2 infection and adverse events, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 to 85 years old.
- •Participants with potential exposure to index patients (with known positive result of qRT-PCR or rapid antigen test [RAT]).
- •Participants will be randomized no longer than 48 hours from the onset of the COVID-19 related symptom of the index patients.
- •Participants with a negative RAT result within 2 hours prior to randomization.
- •Fertile participants must agree to use a highly effective method of contraception.
- •Participants being able and willing to provide informed consent prior to any study-specific procedure.
排除标准
- •Those with high risk of cardiac events, or severe abnormal functions of liver, kidney, lung, brain and other organs and are deemed as unsuitable to participate in the study (except for those subjects with kidney failure but received regular dialysis, or those with liver dysfunction but stabilized after treatment evaluated by the evaluation of the investigators).
- •Those comorbid with asthma.
- •Those with a history of SARS-CoV-2 infection within 3 months prior to randomization.
- •Those who has received any nasal spray or aerosol inhalation COVID-19 vaccine within 3 months prior to randomization.
- •Those who experienced symptom of upper respiratory tract infection within 2 weeks prior to randomization, such as nasal congestion, sore throat, shortness of breath (dyspnea), cough, fatigue, fever, headache, etc.
- •Known history of allergy or reaction to any component of the study drug formulation.
- •Those who has received other treatment with anti-COVID-19 indication (within 1 month or 5 half-life period prior to randomization, whichever occurs first).
- •Participants with nasal disease that is inconvenient or intolerant of nasal spray administration.
- •Other reasons considered by the investigator to be unsuitable for the study.
研究组 & 干预措施
HH-120 group
Experimental
HH-120 Nasal Spray
干预措施: HH-120 Nasal Spray (Drug)
Control group
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The incidence of symptomatic SARS-CoV-2 infection
时间窗: Up to 7 days
Incidence of participants with quantitative Real-Time polymerase chain reaction (qRT-PCR) confirmed SARS-CoV-2 infection and COVID-19 related symptom
次要结局
- Incidence and severity of adverse events(Up to 21 days)
- Time to onset of first COVID-19 related symptom(Up to 7 days)
- The changes in SARS-CoV-2 viral nucleic acid load(Up to 7 days)
- Proportion of participants who progress to moderate/severe/critical type of COVID-19 or death(Up to 21 days)
- The incidence of SARS-CoV-2 infection(Up to 7 days)
- The incidence and titer of antidrug antibody (ADA)(Up to 21 days)
- The change of viral load by qRT-PCR(Up to 7 days)
- The incidence of symptomatic SARS-CoV-2 infection(Up to 5 days)
- The incidence of symptomatic SARS-CoV-2 infection in different subgroups(Up to 7 days)
研究者
研究点 (2)
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