NCT05713318已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19
Huahui Health16 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 16
- 主要终点
- Changes of viral load compared to the baseline
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled Phase 2 study in participants over the age of 18 years with mild COVID-19. The main purpose of this study is to evaluate the effect on viral load clearance and clinical recovery, and safety of HH-120 nasal spray in participants over the age of 18 years with mild COVID-19 (according to the FDA definition, 2021).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who are ≥18 years of age .
- •Participants who are diagnosed with mild COVID-19 and with Laboratory confirmed of SARS-CoV-2 infection as determined by PCR or antigen test.
- •Participants who agree to use highly effective methods of contraception. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test result.
- •Participants who are willing and able to provide written informed consent, or with a legal representative who can provide informed consent.
排除标准
- •Have suspected or proven serious disease (cardiovascular, renal, liver systems, etc.), active bacterial, fungal, viral, or other infection (except COVID 19) that in the opinion of the Investigator could constitute a risk when taking the study intervention.
- •Bronchial asthma or chronic obstructive pulmonary disease （COPD).
- •Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or Extracorporeal membrane oxygenation(ECMO).
- •Have prior use (unless required as rescue medication) of any of the following treatments: COVID 19 investigational or Emergency Use Authorization (EUA) approved treatment, including but not limited to convalescent plasma, mAbs against SARS CoV 2, intravenous immune globulin (IVIG) (any indication), where prior use is defined as the past 30 days or less than 5 half lives of the investigational product (whichever is longer) from Screening.
- •History of anaphylaxis or other significant allergy in the opinion of the PI or known allergy or hypersensitivity to any of the components of the study intervention.
研究组 & 干预措施
Treatment Group 1
Experimental
干预措施: HH-120 nasal spray (Drug)
Treatment Group 2
Experimental
干预措施: HH-120 nasal spray (Drug)
Control Group 3
Placebo Comparator
干预措施: Placebo Comparator (Drug)
Control Group 4
Placebo Comparator
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Changes of viral load compared to the baseline
时间窗: From baseline to Day 7
次要结局
- Time to sustained clinical recovery of 11 COVID-19 symptoms.(From baseline till Day 28)
- Changes of viral load compared to the baseline.(From baseline till Day 28)
- Proportion of participants with moderate, severe, critical COVID-19 disease or death.(From baseline till Day 28)
- Safety assessment: including adverse events, serious adverse events (SAEs), laboratory assessments, etc.(From baseline till Day 28)
研究者
研究点 (16)
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