Trials Sponsors Conditions Drugs Pricing

Brief 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

Effect of Drug Efficacy, Self Virus Infection, RNA

Keywords

Viral loadPVP-ISARS-CoV-2Shelf-lifeStability

Outcome Measures

Primary Outcomes (2)

Viral concentration assessment in Naso-Oropharynx by applying 0.6% PVP-I on COVID-19 positive, moderately ill admitted patient
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).
24 hours
Effectiveness of 0.6% PVP-I assessment through viral concentration measurement
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.
24 hours

Study Arms (4)

Oral and nasal spray to moderately ill COVID-19 positive patient

EXPERIMENTAL

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

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

Oral and nasal spray to asymptomatic to mild COVID-19 patient having multiple comorbidity

EXPERIMENTAL

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

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

Oral and nasal spray to healthy volunteer

EXPERIMENTAL

Interventions

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

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.

Also known as: Group A

Oral and nasal spray to moderately ill COVID-19 positive patient

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

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Hospital admitted patients tested positive COVID-19 within 24 hours in the laboratory by RT-PCR.
Patients with asymptomatic, mild to moderate illness of COVID-19.

Sponsors & Collaborators

Bangladesh Reference Institute of Chemical Measurements (BRICM)
Governmentcollaborator
DR. MALA KHAN
Governmentlead

Study Sites (4)

Bangladesh Reference Institute for Chemical Measurements

Dhaka, Dhanmondi, 1205, Bangladesh

Dhaka Medical College Hospital

Dhaka, 1000, Bangladesh

Kurmitola General Hospital

Dhaka, 1206, Bangladesh

Kuwait-Moitree Hospital

Dhaka, 1230, Bangladesh

MeSH Terms

Conditions

RNA Virus Infections

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Virus DiseasesInfections

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

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

Enrollment

798 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER GOV
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Director General and Chief ScientificOfficer

Study Record Dates

First Submitted

April 26, 2021

First Posted

May 4, 2021

Study Start

April 10, 2021

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (4)

Oral and nasal spray to moderately ill COVID-19 positive patient

Oral and nasal spray to asymptomatic to mild COVID-19 patient having multiple comorbidity

Oral and nasal spray to healthy volunteer

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (2)

Oral and nasal spray by distilled water to control group

You may not qualify if:

Data Sharing

Source record

Documents

Locations

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (4)

Oral and nasal spray to moderately ill COVID-19 positive patient

Oral and nasal spray to asymptomatic to mild COVID-19 patient having multiple comorbidity

Oral and nasal spray to healthy volunteer

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (2)

Oral and nasal spray by distilled water to control group

You may not qualify if:

Data Sharing

Source record

Documents

Locations