Virucidal Effect of PVP-I on COVID-19 and as Well as Safety of Its Application on Nasopharynx & Oropharynx
Status:
Recruiting
Trial end date:
2021-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
DR. MALA KHAN
Collaborator:
Bangladesh Reference Institute of Chemical Measurements (BRICM)