Virucidal Effect of Povidone Iodine on COVID-19 In-Vivo: an Open Label Randomized Clinical Trial
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
- 1
- 主要终点
- Proportion of COVID-19 positive cases following intervention
研究概览
简要总结
It is an established fact that, corona virus spread through the respiratory droplets. Colonization of the virus in oropharynx and/or nasopharynx is considered to be major factor for transmissibility of the virus through respiratory secretions. Preventing colonization of the virus by administrating povidone iodine in the nasal passage therefore, a rational thought which is supported by recent evidence of in-vitro virucidal action of povidone iodine in Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS CoV-2). Therefore, the study is designed to assess the virucidal effect of povidone iodine on COVID-19 virus in-vivo.This open label randomized clinical trial will be conducted at Department of Otorhinolaryngology and Head Neck Surgery, in collaboration with Department of Virology and Department of Medicine in Dhaka Medical College (DMC) Hospital. The study will be conducted from September 2020 to October 2020. Total 175 confirmed cases of COVID-19 disease, proven by Reverse transcription polymerase chain reaction (RT-PCR) testing will be enrolled in this study. Written informed consent will be ensured before participation. In case of no literacy, finger print will be considered for written permission.Consent will be sought from the legal guardian in case of minor or underaged.Formal ethical clearance will be taken from Ethical Review Committee (ERC) of Dhaka Medical College. All of the Participants will be divided into seven groups: Group A will receive Povidone iodine (PVP-I) nasal irrigation at concentration of 0.4%, Group B and Group C will received 0.5% and 0.6%; Group D will receive PVP-I nasal spray at concentration of 0.5% and Group E will received at 0.6% concentration. Group F (Placebo comparator group) will receive nasal irrigation by distilled water (DW) and Group G (Placebo comparator group) will received nasal spray by distilled water. The contact time will be minimum 30 seconds. After the individual application of PVP-I and distilled water in respective participant, they will be tested again for RT-PCR for COVID-19 from nasopharyngeal and oropharyngeal sample. All patients will be subjected to detail history, physical examination and adverse events. Block Randomization will be followed for randomization. Data will be recorded in a semi-structured questionnaire and will be analyzed by 'R-4.0.2' data analysis software
详细描述
Rationale of the study
The coronavirus disease 2019 (COVID-19) is a highly infectious disease and cause human to human transmission primarily by respiratory droplets from coughing, sneezing and speaking. In early SARS-CoV-2 infection, a greater viral titre can be found in saliva and nasal mucous; minimization of these titres should help to reduce cross infection. Povidone-iodine (PVP-I) disinfectant has better anti-viral activity than other antiseptics and has already been proven to be an extremely effective virucide in vitro against severe acute respiratory syndrome and Middle East respiratory syndrome coronaviruses (SARS-CoV and MERS-CoV). Its' in vivo virucidal activity is unknown, though its nasal or oral preparation can be effective in reducing transmission. Earlier, a very few studies have evaluated the efficacy of povidone-iodine as nasal antiseptics or oral rinse antiseptics against the SARS-CoV-2 virus but the result of those studies are not undebatable. So aim of this study is to investigate the virucidal activity of povidone iodine on coronavirus located on the mucosal surface of oropharynx and nasopharynx and is very rational in this pandemic period.
Research Hypothesis:
Objectives:
General Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 15-90 years
- •Either gender
- •Patients diagnosed with COVID-19 disease by RT-PCR
- •Have confirmed COVID-19 symptoms and symptom onset within the past 10 days
- •Capable of using a nasal spray device and perform nasal irrigation required by the study
- •Willing to participate
排除标准
- •Patient with known sensitivity to PVP-I aqueous antiseptic solution or any of its listed excipients
- •Previously diagnosed thyroid disease
- •Patients with chronic renal failure (stage ≥3 by estimated Glomerular Filtration rate (eGFR) Modification of Diet in Renal Disease( MDRD)
- •Patients with acute renal failure (KDIGO ≥stage 2: creatinine ≥2 X baseline)
- •Pregnant and lactating mother
- •Current requirement for invasive or non-invasive ventilation or planned within next 6 hours.
研究组 & 干预措施
PVP-I 0.4% NI
Arm-1 will receive Povidone iodine (PVP-I) nasal irrigation (NI) at concentration of 0.4% single time
干预措施: Povidone-Iodine 0.4% NI (Drug)
PVP-I 0.5% NI
Arm-2 will receive Povidone iodine (PVP-I) nasal irrigation at concentration of 0.5% single time
干预措施: Povidone-Iodine 0.5% NI (Drug)
PVP-I 0.6% NI
Arm-3 will receive Povidone iodine (PVP-I) nasal irrigation at concentration of 0.6% single time
干预措施: Povidone-Iodine 0.6% NI (Drug)
PVP-I NS 0.5% NS
Arm-4 will receive will receive PVP-I nasal spray (NS) at concentration of 0.5% single time
干预措施: Povidone-Iodine 0.5% NS (Drug)
PVP-I 0.6% NS
Arm-5 will receive will receive PVP-I nasal spray at concentration of 0.6% single time
干预措施: Povidone-Iodine 0.6% NS (Drug)
结局指标
主要结局
Proportion of COVID-19 positive cases following intervention
时间窗: 5 minutes-30 minutes
Proportion of COVID-19 positive cases following intervention in all groups
次要结局
- Adverse events(1 minute to 24 hours)
研究者
DR. MALA KHAN
Director General
Bangladesh Reference Institute of Chemical Measurements (BRICM)