Accelerating COVID-19 Clinical Recovery in the Outpatient Setting: Retrospective Data Collection and Analysis of COVID-19 Patients Treated With ClorNovir® (Chlorpheniramine Maleate (0.4% Nasal Spray)
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence of significant COVID-19-related clinical events
研究概览
简要总结
The purpose of this retrospective study is to evaluate the effectiveness of CPM nasal spray as part of the treatment of COVID-19 and its impact on clinical symptoms. Two cohort groups will be compared (CPM vs. standard care). The hypothesis to be tested is that patients treated with CPM nasal spray showed more rapid clinical improvement than those treated with standard of care alone. Clinical improvement will be evaluated by the total number of days with the manifestation of COVID-19 symptoms, including cough, nasal congestion, ageusia, and anosmia, among others. The rate of hospitalization between the cohorts will also be evaluated.
详细描述
The following are categories of interest in patients with COVID-19 treated with ClorNovir:
- Clinical outcomes, as assessed by clinical assessments of clinical symptoms, and incidence of significant clinical events
- Clinical recovery, as assessed by patient-reported outcome measures and clinician-reported outcomes.
The safety objective is to assess the safety and tolerability of ClorNovir.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients with a documented diagnosis of SAR-CoV-2
- •Patients with positive RT-PCR or antigen test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs
- •Both vaccinated and unvaccinated (high-risk) persons will be included.
- •Willing and able to provide written informed consent (ages greater or equal to 18 years) or parental/guardian consent and patient assent (age <18 years), as required by the IRB or institution or IRB, per local regulations
排除标准
- 未提供
研究组 & 干预措施
Retrospective Data Collection
干预措施: ClorNovir® (Chlorpheniramine) 0.4% Nasal Spray (Drug)
结局指标
主要结局
Incidence of significant COVID-19-related clinical events
时间窗: Baseline through Day 10-End of Treatment
Such as anosmia, dysgeusia, cough, and nasal congestion.
Incidence and severity of adverse events (AEs) of interest
时间窗: Baseline through Day 10-End of Treatment
Such as irritation in the nasal fossa, Headache, Epistaxis, modification or discontinuation
Time to Clinical Recovery
时间窗: Baseline through Day 10-End of Treatment
Defined as the change from baseline to end of treatment in COVID-19 symptoms on a 10-item ordinal scale\* ("A minimal common outcome measure set for COVID-19 clinical research," 2020).
Incidence and severity of serious adverse events (SAEs)
时间窗: Baseline through Day 10-End of Treatment
treatment period in the incidence of hospitalizations
时间窗: Baseline through Day 10-End of Treatment
次要结局
未报告次要终点