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

NCT04549376 | Completed Phase 2 DMC

• 1 other identifier: BRiCM-1131-2020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

COVID19; prevention; Povidone Iodine; Low and middle income countries

Outcome Measures

Primary Outcomes (1)

• Proportion of COVID-19 positive cases following intervention

  Proportion of COVID-19 positive cases following intervention in all groups

  5 minutes-30 minutes

Secondary Outcomes (1)

• Adverse events

  1 minute to 24 hours

Study Arms (7)

PVP-I 0.4% NI

EXPERIMENTAL

Arm-1 will receive Povidone iodine (PVP-I) nasal irrigation (NI) at concentration of 0.4% single time

Drug: Povidone-Iodine 0.4% NI

PVP-I 0.5% NI

EXPERIMENTAL

Arm-2 will receive Povidone iodine (PVP-I) nasal irrigation at concentration of 0.5% single time

Drug: Povidone-Iodine 0.5% NI

PVP-I 0.6% NI

EXPERIMENTAL

Arm-3 will receive Povidone iodine (PVP-I) nasal irrigation at concentration of 0.6% single time

Drug: Povidone-Iodine 0.6% NI

PVP-I NS 0.5% NS

EXPERIMENTAL

Arm-4 will receive will receive PVP-I nasal spray (NS) at concentration of 0.5% single time

Drug: Povidone-Iodine 0.5% NS

PVP-I 0.6% NS

EXPERIMENTAL

Arm-5 will receive will receive PVP-I nasal spray at concentration of 0.6% single time

Drug: Povidone-Iodine 0.6% NS

DW NI

PLACEBO COMPARATOR

Arm-6 will receive distilled water through nasal irrigation

Other: Placebo comparator: DW-NI

DW NS

PLACEBO COMPARATOR

Arm-7 will receive distilled water through nasal spray

Other: Placebo comparator: DW-NS

Interventions

Povidone-Iodine 0.4% NI DRUG

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

Also known as: Povidone-Iodine 0.4%

PVP-I 0.4% NI

Povidone-Iodine 0.5% NI DRUG

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

Also known as: Povidone-Iodine 0.5%

PVP-I 0.5% NI

Povidone-Iodine 0.6% NI DRUG

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

Also known as: Povidone-Iodine 0.6%

PVP-I 0.6% NI

Povidone-Iodine 0.5% NS DRUG

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

Also known as: Povidone-Iodine 0.5%

PVP-I NS 0.5% NS

Povidone-Iodine 0.6% NS DRUG

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

Also known as: Povidone-Iodine 0.6%

PVP-I 0.6% NS

Placebo comparator: DW-NI OTHER

Nasal irrigation will be provided by Distilled water

Also known as: Distilled water (DI) in the form of Nasal Irrigation

DW NI

Placebo comparator: DW-NS OTHER

Nasal spray will be provided by Distilled water

Also known as: Distilled water (DI) in the form of Nasal spray

DW NS

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 15-90 years
• Either gender
• Patients diagnosed with COVID-19 disease by RT-PCR
• Have confirmed COVID-19 symptoms and symptom onset within the past 10 days
• Capable of using a nasal spray device and perform nasal irrigation required by the study
• Willing to participate

You may not qualify if:

• Patient with known sensitivity to PVP-I aqueous antiseptic solution or any of its listed excipients
• Previously diagnosed thyroid disease
• Patients with chronic renal failure (stage ≥3 by estimated Glomerular Filtration rate (eGFR) Modification of Diet in Renal Disease( MDRD)
• Patients with acute renal failure (KDIGO ≥stage 2: creatinine ≥2 X baseline)
• Pregnant and lactating mother
• Current requirement for invasive or non-invasive ventilation or planned within next 6 hours.

Sponsors & Collaborators

• DR. MALA KHAN: lead
• Dhaka Medical College: collaborator

Study Sites (1)

Dhaka Medical College

Dhaka, 1000, Bangladesh

Location

Related Publications (2)

• Kamal Arefin M, Banu SS, Nasir Uddin AKM, Nurul Fattah Rumi SK, Khan M, Kaiser A, Arafat MS, Chowdhury JA, Khan MAS, Hasan MJ. Virucidal Effect of Povidone Iodine on SARS-CoV-2 in Nasopharynx: An Open-label Randomized Clinical Trial. Indian J Otolaryngol Head Neck Surg. 2022 Oct;74(Suppl 2):3283-3292. doi: 10.1007/s12070-022-03106-0. Epub 2022 May 6.

  PMID: 35572740 DERIVED

• Hasan MJ, Rumi SKNF, Banu SS, Uddin AKMN, Islam MS, Arefin MK. Virucidal effect of povidone iodine on COVID-19 in the nasopharynx: A structured summary of a study protocol for an open-label randomized clinical trial. Trials. 2021 Jan 4;22(1):2. doi: 10.1186/s13063-020-04963-2.

  PMID: 33397432 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Prof Sk Nurul Fattah Rumi, MBBS, MS

  Dhaka Medical College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director General

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 16, 2020
• Study Start: July 1, 2020
• Primary Completion: October 20, 2020
• Study Completion: October 30, 2020
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: 6 months
• Access Criteria: Available on public domain like figshare, researchgate and others

Locations

BA (1)