A Multicentric, Randomized, Double-Blind, Comparative, Prospective, Placebo-controlled, Phase-II/III Clinical Trial (ACCROS-III)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
The goal of this clinical trial is to examine the effectiveness of intranasal-administered Chlorpheniramine Maleate in COVID-19-positive participants as part of early treatment for COVID-19. The main questions it aims to answer are:
- To assess the efficacy of nasal spray with Chlorpheniramine (0.4%) for improving clinical recovery in COVID-19 patients.
- To assess the efficacy, safety, and tolerability of nasal spray with Chlorpheniramine (0.4%) as an adjunct to the standard of care in reducing hospitalizations and improving clinical recovery in adult patients with mild COVID-19.
详细描述
The main goal of the present study is to examine the effectiveness of CPM intranasal spray as part of early treatment for COVID-19. The study will test the hypothesis that intranasal CPM would accelerate clinical recovery, particularly the alleviation of sensory symptoms and URS, in patients with COVID-19.
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
- Double (Participant, Investigator)
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
- 是
入选标准
- •Male or female patients between 18 and 65 years (both inclusive)
- •Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected or proof of positive test ≤3 days before randomization)
- •Patients with mild COVID-19 have the following symptoms and signs prior to randomization (≤ 3days)
- •Upper respiratory tract symptoms (&/or fever) without shortness of breath or hypoxia. (SpO2 > 94 %)
- •Willingness to sign written informed consent document
排除标准
- •< 18 years of age
- •Hospitalized patients
- •Subject with known allergy or hypersensitivity to the components of the formulation.
- •Patients receiving therapy with Monoamine oxidase inhibitors (MAOIs): rasagline, selegiline, isocarbonboxasid, phenelzine, tranylcypromine.
- •Patients with narrow-angle glaucoma
- •urinary retention
- •Sleep Apnea
- •History of immunodeficiency or receiving immunosuppressive therapy.
- •Patients with acute exacerbation of severe comorbidities such as chronic obstructive pulmonary disease (COPD), class 3 and 4 heart failure diagnosed according to the criteria of the New York Heart Failure Association (NYHA), or diseases with severe oxygenation problems
- •Any Surgical procedure in the past 12 weeks
- •Unable to make informed consent or refuse or renounce adherence to standard treatment protocols.
- •Any significant illness or drugs that could interfere with study parameters
- •Any other condition based on the investigator's clinical judgment does not justify the patient's participation in the study.
- •Participation in another clinical trial within the past 30 days
- •Clinically significant arrhythmia or symptomatic cardiac conditions including but not limited to QT elongation
- •QT interval less than 300 ms or more than 500 ms for both men and women.
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: Baseline through day 7
Change from baseline visual analog scale (VAS) to day 7 The VAS is a quantitative method that evaluates the severity of symptoms on a scale of 1-10 (no signs to worst symptoms). A 10 cm line is used to grade the severity of symptoms from "no symptoms" (0 cm) to "the highest level of symptoms" (10 cm).
Daily symptoms score (DSS)
时间窗: Baseline through day 7
Change from baseline daily symptoms score (DSS) to day 7 The DSS is an instrument comprised of a four-point severity rating scale ranging from 0 to 3. 0 = no symptoms 1. = mild symptoms 2. = moderate symptoms 3. = severe symptoms.
次要结局
- Hospitalization(Baseline through Day 28)
- Mortality(Baseline through Day 28)
- The proportion of subjects reporting olfactory function(Baseline through Day 7)
- The proportion of subjects reporting the presence of upper respiratory symptoms(Baseline through Day 7)