The Efficacy of Topical Povidone-Iodine Rinses in the Management of the Coronavirus Disease 2019 (COVID-19)
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in SARS-CoV-2 positivity in the saliva
研究概览
简要总结
The aim of this study is to determine if Povidone iodine (PVP-I) rinses and throat gargles or a PVP-I gel forming nasal spray compared to a placebo (a treatment that has no physical effect to a person) is an effective treatment for patients diagnosed with COVID-19. These patients have been diagnosed with mild/moderate COVID-19 symptoms and sent home for self-isolation. Patients will be instructed to take either of the two treatments or placebo twice daily for two weeks and have follow up visits 2 and 4 weeks after. The participants will also complete study related procedures such as saliva sample collection, and two questionnaires throughout the study period. The investigators hypothesize that COVID 19 positive participants who use either of the Povidone - Iodine treatment will have a reduction in their viral load, develop a negative oral mucosa sample and improve their clinical symptoms.
详细描述
The proposed study is a prospective randomized double blinded placebo-controlled study of 6-weeks in duration. Patients who have tested positive and diagnosed with COVID-19 within the previous 72 h and who meet the inclusion and exclusion criteria, will be invited to participate in this study.
This study will be involving non-hospitalized patients who are recovering at home. One arm will use betadine sinonasal rinses and a betadine mouth gargle while another arm will act as a control receiving a placebo (a food coloring agent). A third arm will use a 0.6% PVP-I gel forming nasal spray twice daily. A baseline saliva sample will be collected to assure a positive COVID-19 test and to quantify viral load. Repeat saliva samples will be collected every 2 days for 2 weeks, then at 4 weeks and 6 weeks to quantify test status and quantify viral load reduction. WURSS-44 questionnaires will be completed daily for 2 weeks and then again at 4 weeks and 6 weeks. SNOT-22 questionnaires will be completed at baseline and then again at 2 weeks, 4 weeks, and 6 weeks. The investigators will also monitor for worsening of symptoms and the need for hospitalization for the entire 6 week duration of the study.
Upon enrolment in the study after obtaining positive results for COVID-19, demographic data and clinical data will be obtained by the investigators. Patients will be randomly assigned to one of the study arms delineated above by permuted block randomization
The clinical samples that detect COVID-19 are obtained by collecting a saliva sample prior to rinsing. This will avoid confounding by artificially lowering the viral particles sampled and will minimize any potentially inhibitory effects of the intervention compounds on lab detection. The sample will be put into a sterile collection container and stored in the fridge until it is transported to the laboratory for analysis.
Sample Size
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)
盲法说明
The investigator will be blinded to whether or not the patients are receiving either active treatments or placebo, and assignments will be concealed throughout the study. The patients will know if they are in the nasal gel spray or rinse group but will be blinded to whether or not they are receiving the active treatment or placebo if they are randomized into the rinse group.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years or older
- •Patients diagnosed with laboratory-confirmed SARS-CoV-2 and the development of COVID-19 compatible symptoms within the last 72 hours before enrolment
- •Do not require hospitalization
排除标准
- •Sinonasal tumor
- •Hypersensitivity to iodine or betadine
- •History of thyroid disorder including thyroid cancer, hyperthyroidism and hypothyroidism
- •Use of medications for thyroid disorders including thyroxine and carbimazole
- •Current use of topical iodine or betadine for another reason
- •Participating in any study with therapies directed at COVID-19 that could influence our results
- •Are pregnant or breastfeeding
研究组 & 干预措施
PVP-I sinus rinses and throat gargles
Participants will dilute 7 mL of 10% PVP-I into 300 mL of saline for a final concentration of 0.23% available iodine. They will be instructed to rinse each nostril with 120ml (total 240mL) in a NeilMedTM sinus rinse bottle, and gargle with 60 mL of the solution.
干预措施: Povidone-iodine (Drug)
Placebo sinus rinses and throat gargles
Participants will dilute 7 mL of PVP-I placebo into 300 mL of saline. They will be instructed to rinse each nostril with 120ml (total 240mL) in a NeilMedTM sinus rinse bottle, and gargle with 60 mL of the solution.
干预措施: Placebo (Drug)
PVP-I gel forming nasal spray
0.6% PVP-I gel forming nasal spray will come prepared and ready for participants to use. They will be instructed to use two sprays to each nostril each time they administer the spray.
干预措施: Povidone-iodine (Drug)
结局指标
主要结局
Change in SARS-CoV-2 positivity in the saliva
时间窗: A saliva sample will be taken every 2 days for 2 weeks, and again at 4 and 6 weeks
A saliva sample will be analyzed to monitor the duration of positivity and when test becomes negative for SARS-CoV-2.
Change in the SAR-CoV-2 viral load in the saliva
时间窗: A saliva sample will be taken every 2 days for 2 weeks, and again at 4 and 6 weeks
Quantify the amount of SAR-CoV-2 viral load present in the saliva.
次要结局
- Change in Wisconsin Upper Respiratory Symptom Survey (WURSS-44)(daily for 2 weeks, 4 weeks, and 6 weeks)
- Change Sino nasal Outcome Test (SNOT-22)(baseline, 2 weeks, 4 weeks, 6 weeks)
- Change in clinical condition(daily for 2 weeks, 4 weeks, and 6 weeks)
研究者
Amin Javer
Assistant Clinical Professor
St. Paul's Hospital, Canada