Virucidal Effect of Povidone Iodine on COVID-19 In-Vivo

Summary

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

Conditions

• COVID19

Interventions

DRUG

Povidone-Iodine 0.4% NI

Povidone iodine (PVP-I) nasal irrigation at concentration of 0.4%

DRUG

Povidone-Iodine 0.5% NI

Povidone iodine (PVP-I) nasal irrigation at concentration of 0.5%

DRUG

Povidone-Iodine 0.6% NI

Povidone iodine (PVP-I) nasal irrigation at concentration of 0.6%

DRUG

Povidone-Iodine 0.5% NS

Povidone iodine (PVP-I) nasal spray at concentration of 0.5%

DRUG

Povidone-Iodine 0.6% NS

Povidone iodine (PVP-I) nasal spray at concentration of 0.6%

OTHER

Placebo comparator: DW-NI

Nasal irrigation will be provided by Distilled water

OTHER

Placebo comparator: DW-NS

Nasal spray will be provided by Distilled water

Sponsors & Collaborators

• Dhaka Medical College

  collaborator OTHER

• DR. MALA KHAN

  lead OTHER_GOV

Principal Investigators

• Prof Sk Nurul Fattah Rumi, MBBS, MS · Dhaka Medical College

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-01

Primary Completion

2020-10-20

Completion

2020-10-30

Countries

• Bangladesh

Study Locations