A Multicenter, Single Blind, Randomized Controlled Trial of Virucidal Effect of Polyvinyl Pyrrol-Iodine on SARS-CoV-2 as Well as Safety of Its Application on Nasopharynx & Oropharynx of COVID-19 Positive Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 798
- 试验地点
- 4
- 主要终点
- Effectiveness of 0.6% PVP-I assessment through viral concentration measurement
研究概览
简要总结
The COVID-19 pandemic is the defining global health crisis of our time and the greatest challenge we have faced since World War-II.Corona virus is transmitted via respiratory droplets or aerosol, produced from sneezing or coughing of infected persons to healthy individual through mouth, nose and eye. PVP-I gargle/spray used in throat and nose are shown to have broad spectrum antimicrobial activity and may have preventive effect on SARS-CoV-2.
0.6% PVP-I oro-nasal spray phase 3 clinical trial will be conducted in three dedicated Covid-19 hospitals namely Dhaka Medical College Hospital, Kurmitola General Hospital, Kuwait-Moitree Hospital. Chemical compound of the oro-nasal spray which was developed and tested at Bangladesh Reference Institute for Chemical Measurements, for its quality control/ quality assurance, shelf life and related stability following GLP guideline.
This study aims to evaluate virucidal efficacy of 0.6% PVP-I against SARS-CoV-2 along with its safe uses in oronasal mucosa of healthy and SARS-CoV-2 exposed persons.
The participant will be divided into three groups: Group A 768 COVID-19 positive, moderately ill admitted patient who will receive intervention once. Group B 20 asymptomatic to mild COVID-19 patients having multiple comorbidity will receive intervention 4 times hourly and Group C 10 healthy individual who accept intervention 0.6% PVP-I oronasal spray 3-4 times interval in a day for 30 days. Placebo will be used among control group for better comparison.
The chemical which will be used in this study is available inside the country and also registered to open use in Bangladesh. BRiCM ensures raw material & impurities characterization as per BP 2019, AOAC and AWWA and determination of shelf life by performing the stability studies will be conducted according to Stability Zone Iva and ICH guidelines.
A written consent will be taken by concern participant and a short interview will be taken on the spot prior to intervention. Participant's medical documents will be used and swab from nasopharynx & oropharynx will be taken for performing necessary test (RT-PCR) to confirm viral presence.
There is no potential risk for application of this oro-nasal spray. Even though if any adverse reaction occur while using the oro-nasal spray, necessary medical management will be carried out in the respected hospital.
详细描述
Introduction:
COVID-19 pandemic is the defining global health crisis of our time and the greatest challenge we have faced since World War Two. We have now reached the tragic milestone of two million deaths, and the human family is suffering under an almost intolerable burden of loss.
Background Information:
- Description of Bangasafe (proposed name) Oro-Nasal Spray: The spray contains PVP-I is a water-soluble iodophor that consists of a complex between iodine and a solubilizing polymer carrier, polyvinylpyrrolidone. In aqueous solution, a dynamic equilibrium occurs between free iodine, the active virucidal agent, and the PVP-I-complex.
- Composition: Oro-Nasal spray contains 0.6% PVP-I as an Active Pharmaceutical Ingredients (API) in sterile de-ionized water.
- Product Development, Quality Control and Quality Assurance: Following aspects of raw materials including API, manufacturing in-process steps, finished product are to be real time monitored and produced in Bangladesh Reference Institute for Chemical Measurements,
- Raw materials characterization: Appearance, solubility, identification, nitrogen content, iodide value, loss on drying, pH, sulphated ash and available iodine.
- Solvent/diluent characterization: pH, conductivity, total organic carbon, heavy metal (Pb, As), endotoxin, microbial count.
- Quality testing in several stages during product development: pH, available iodine, iodide, UV absorbance, potency.
- Impurity profile testing: 1-Vinyl-2-pyrrolidinone, 2-Pyrrolidinone, heavy metal (Pb)
- Accelerated & real time stability study and shelf-life determination: pH, available iodine, iodide, UV absorbance Up to 3 (three) month at 25C, 30C and 35C
- Mode of Action: PVP itself has no microbicidal activity but rather delivers the free iodine to target cell membranes. The basic mechanism leads to strong microbicidal activity expressed by multiple modes of action as oxidation of amino acids and nucleic acids that disrupt the microbial metabolic pathways, as well as destabilization of the structural components of cell membranes, causing irreversible damage to the pathogen.
- Dosage and Administration: Mouth & Nostril: 2 puffs, in 3-4 hours interval not more than 4 times a day.
- How Supplied: Oro-nasal spray aqueous solution containing 0.6%PVP-I is supplied in 30ml amber color High Density Poly Ethylene (HDPE) bottle designed for pharmaceutical packaging to provide adequate protection against sun light.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individual (non COVID-19)
- •Age -18 years and above (as below18 years lesser concentration of drug may be required).
- •Consent of the participants who wish to participate.
- •Exclusion criteria:
- •Participants who has any major comorbidity.
- •Participants having thyroid dysfunction, pregnant or lactating mother.
- •It should not be used prior to or after radioiodine scintigraphy or radioiodine treatment of thyroid carcinoma.
- •Participants allergic to iodine should be avoided
- •Have participated in other clinical study
- •Subjects with other severe acute or chronic conditions that may increase the risk of participation in the study and study treatment, or may interfere with interpretation of study results, and judged by the investigator as not suitable for participation in this clinical trial.
排除标准
- 未提供
研究组 & 干预措施
Oral and nasal spray to moderately ill COVID-19 positive patient
Drug Name: Povidone-Iodine Dosage form: 0.6% Povidone-Iodine Dosage: 2 puff 0.6% PVP-I in each nostril and 2 puff inside mouth Frequency and duration: Single
干预措施: 0.6% PVP-I oral and nasal spray to moderately ill COVID-19 positive patient (Drug)
Oral and nasal spray to asymptomatic to mild COVID-19 patient having multiple comorbidity
Drug Name: Povidone-Iodine Dosage form: 0.6% Povidone-Iodine Dosage: 2 puff 0.6% PVP-I in each nostril and 2 puff inside mouth Frequency and duration: hourly for 4 hours in a single day
干预措施: 0.6% PVP-I Oral and nasal spray to asymptomatic to mild COVID-19 patient having multiple comorbidity (Drug)
Oral and nasal spray to healthy volunteer
Drug Name: Povidone-Iodine Dosage form: 0.6% Povidone-Iodine Dosage: 2 puff 0.6% PVP-I in each nostril and 2 puff inside mouth Frequency and duration: 3-4 times interval but not more than 4 times a day for 30 days
干预措施: 0.6% PVP-I Oral and nasal spray to healthy volunteer (Drug)
Oral and nasal spray by distilled water to control group
Placebo comparator: Distilled water Dosage form: Oral and Nasal spray will be provided by Distilled water
干预措施: Oral and nasal spray by distilled water to control group (Other)
结局指标
主要结局
Effectiveness of 0.6% PVP-I assessment through viral concentration measurement
时间窗: 24 hours
Selection of 20 patients randomly with no or mild symptoms and obtain their consent for the further tests. Then application of 0.6% PVP-I spray 4 times (2 puff 0.6% PVP-I containing oronasal spray to each nostril and 2 puff inside mouth). Then collection of 2nd, 3rd and 4th sample from nasopharynx and oropharynx hourly for RT-PCR test to assess the viral concentration.
Viral concentration assessment in Naso-Oropharynx by applying 0.6% PVP-I on COVID-19 positive, moderately ill admitted patient
时间窗: 24 hours
Application of 0.6% PVP-I spray once (2 puff 0.6% PVP-I in each nostril and 2 puff inside mouth) to experimental group and distilled water to control group. Then follow up (waiting for 2-5 minutes) and collection of nasopharyngeal and oropharyngeal sawab for RT-PCR test for both group to assess viral concentration. Observation of the patients for 30 minutes for possible early adverse effects (if any) and subsequent management (if needed).
次要结局
- Serum creatinine concentration determination for assessing side effect on kidney function after using 0.6% PVP-I oronasal spray on healthy volunteer(10 Days)
- TSH, FT3, FT4 and Unirine iodine concentration determination for assessing side effect on thyroid function after using 0.6% PVP-I oronasal spray on healthy volunteer(10 Days)
研究者
DR. MALA KHAN
Director General and Chief ScientificOfficer
Bangladesh Reference Institute of Chemical Measurements (BRICM)