Virucidal Effect of PVP-I on COVID-19 and as Well as Safety of Its Application on Nasopharynx & Oropharynx

Summary

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.

Conditions

• Virus Infection, RNA
• Effect of Drug
• Efficacy, Self

Interventions

DRUG

0.6% PVP-I oral and nasal spray to moderately ill COVID-19 positive patient

Number of participants 768 COVID-19 positive, moderately ill admitted patient who will receive intervention Step 1: Enrollment of the study populations by applying inclusion and exclusion criteria Step 2: Randomization to allocate experimental and controlled group by using table of random number Step 3: Application of 0.6% PVP-I spray to experimental group and distilled water to control group Step 4: Follow up (waiting for 2-5 minutes) Step 5: Collection of nasopharyngeal and oropharyngealsawab for RT-PCR test for both group Step 6: Observation of the patients for 30 minutes for possible early adverse effects (if any) and subsequent management (if needed). Step 7: Analysis data collection, data processing and analysis by using SPSS software.

DRUG

0.6% PVP-I Oral and nasal spray to asymptomatic to mild COVID-19 patient having multiple comorbidity

Number of participants 20 asymptomatic to mild COVID -19 patients having multiple comorbidity who will receive intervention Step 1: Selection of 20 patients randomly with no or mild symptoms and obtain their consent for the further tests. Step 2: Collection of 2nd, 3rd and 4th sample from nasopharynx and oropharynx hourly Step 3: Data collection, data processing and analysis by using SPSS software

DRUG

0.6% PVP-I Oral and nasal spray to healthy volunteer

Number of participants 10 healthy individual who accept intervention 0.6% PVP-I oronasal spray Step 1: Selection of 10 healthy volunteers randomly who will be selected for using 0.6% PVP-I Oro-Nasal spray 2 puff inside both nostrils and mouth 3 to 4 times a day for one month. Step 2: Collection of blood \& urine of participants on day 0, 10, 20, 30 for determination of any change in biochemical marker (thyroid, kidney and liver functions will be done) Step 3: Data collection, data processing and analysis by using SPSS software

OTHER

Oral and nasal spray by distilled water to control group

Placebo comparator: Distilled Water Oral and Nasal spray will be provided by Distilled water to control group

Sponsors & Collaborators

• Bangladesh Reference Institute of Chemical Measurements (BRICM)

  collaborator OTHER_GOV

• DR. MALA KHAN

  lead OTHER_GOV

Principal Investigators

• Mostafa Kamal Arefin, Dr. · Indoor Medical Officer, Department of ENT & Head-Neck Surgery, Dhaka Medical College Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-10

Primary Completion

2021-05-25

Completion

2021-05-30

Countries

• Bangladesh

Study Locations