Role of NaSo-oropHaryngeal Antiseptic dEcolonizaiton to Reduce Covid-19 Viral Shedding and Disease Transmission: SHIELD Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Number of Participants with COVID-19 diagnosis
研究概览
简要总结
Essential workers in positions with increased likelihood of exposure to SARS-CoC-2 will be most impacted by the proposed project. Evidence has shown that the SARS-CoV-2 novel coronavirus is easily transmissable through close contact between individuals, especially during aerosol-generating procedures such as intubation of patients. The intervention proposed in this study (nasal and oral decontamination with povidone-iodine and chlorhexidine, respectively) presents an opportunity for a safe, effective, and feasible treatment to decontaminate the primary entry points for SARS-CoV-2. As such, the intervention to be studied in this project may protect healthcare and other essential workers by preventing transmission of SARS-CoV-2 from patients to healthcare workers, as well as the general public to essential worker,. and thus reducing the incidence of COVID-19 in these workers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is a essential worker performing at least some in-person job duties (not 100% remote)
- •Participant is willing and able to perform intervention and data collection procedures.
- •Participant is able to provide informed consent in English language.
排除标准
- •Diagnosis of COVID-19 within 2 months prior to enrollment, or active respiratory illness symptoms at time of enrollment
- •Known medical contraindication to chlorhexidine gluconate or povidone-iodine treatment ingredients (such as a known allergy)
- •Participant has a known medical and/or surgical reason prohibiting nasal swab sampling.
- •Participant is female who is pregnant, or believes she may be pregnant, at time of enrollment.
- •Participant is actively taking/using any treatments or interventions as part of any other COVID-19 related investigational trials.
研究组 & 干预措施
Control > Active Intervention
Treatment is 3 weeks of standard personal protective equipment without any povidone-iodine (PI) or chlorhexidine gluconate (CHG) intervention (control), followed by a 2 weeks washout period, and 3 weeks of nasal (10% povidone-iodine swab sticks in each nostril) and CHG oral decolonization (swish and spit 15 ml 0.12% CHG oral rinse for 30 seconds, four times/day) procedures.
干预措施: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse (Drug)
Active Intervention > Control
Treatment is 3 weeks of nasal (10% povidone-iodine swab sticks in each nostril) and CHG oral decolonization (swish and spit 15 ml 0.12% CHG oral rinse for 30 seconds, four times/day) procedures, followed by 2 weeks of washout, and 3 weeks of standard personal protective equipment without any PI or CHG intervention (control).
干预措施: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse (Drug)
结局指标
主要结局
Number of Participants with COVID-19 diagnosis
时间窗: 8 weeks
Participants will be monitored for positive COVID-19 test results during this trial
SARS-Cov-2 Viral Load
时间窗: 8 weeks
Viral load will be measured as a continuous outcome for each participant (three times per week) throughout this trial.
次要结局
- Feasibility of the treatment regimen(2 weeks total: 1 week (pre-intervention) and 1 week after completion of intervention (post-intervention))
- Fidelity of the treatment regimen(8 weeks)