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Virucidal Effect of Povidone Iodine on COVID-19 In-Vivo (VEP-COV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04549376
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Dhaka Medical College
Information provided by (Responsible Party):
Pi Research Consultancy Center, Bangladesh

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

Condition or disease Intervention/treatment Phase
COVID19 Drug: Povidone-Iodine 0.4% NI Drug: Povidone-Iodine 0.5% NI Drug: Povidone-Iodine 0.6% NI Drug: Povidone-Iodine 0.5% NS Drug: Povidone-Iodine 0.6% NS Other: Placebo comparator: DW-NI Other: Placebo comparator: DW-NS Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Virucidal Effect of Povidone Iodine on COVID-19 In-Vivo: an Open Label Randomized Clinical Trial
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : October 20, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PVP-I 0.4% NI
Arm-1 will receive Povidone iodine (PVP-I) nasal irrigation (NI) at concentration of 0.4% single time
Drug: Povidone-Iodine 0.4% NI
Povidone iodine (PVP-I) nasal irrigation at concentration of 0.4%
Other Name: Povidone-Iodine 0.4%

Experimental: PVP-I 0.5% NI
Arm-2 will receive Povidone iodine (PVP-I) nasal irrigation at concentration of 0.5% single time
Drug: Povidone-Iodine 0.5% NI
Povidone iodine (PVP-I) nasal irrigation at concentration of 0.5%
Other Name: Povidone-Iodine 0.5%

Experimental: PVP-I 0.6% NI
Arm-3 will receive Povidone iodine (PVP-I) nasal irrigation at concentration of 0.6% single time
Drug: Povidone-Iodine 0.6% NI
Povidone iodine (PVP-I) nasal irrigation at concentration of 0.6%
Other Name: Povidone-Iodine 0.6%

Experimental: PVP-I NS 0.5% NS
Arm-4 will receive will receive PVP-I nasal spray (NS) at concentration of 0.5% single time
Drug: Povidone-Iodine 0.5% NS
Povidone iodine (PVP-I) nasal spray at concentration of 0.5%
Other Name: Povidone-Iodine 0.5%

Experimental: PVP-I 0.6% NS
Arm-5 will receive will receive PVP-I nasal spray at concentration of 0.6% single time
Drug: Povidone-Iodine 0.6% NS
Povidone iodine (PVP-I) nasal spray at concentration of 0.6%
Other Name: Povidone-Iodine 0.6%

Placebo Comparator: DW NI
Arm-6 will receive distilled water through nasal irrigation
Other: Placebo comparator: DW-NI
Nasal irrigation will be provided by Distilled water
Other Name: Distilled water (DI) in the form of Nasal Irrigation

Placebo Comparator: DW NS
Arm-7 will receive distilled water through nasal spray
Other: Placebo comparator: DW-NS
Nasal spray will be provided by Distilled water
Other Name: Distilled water (DI) in the form of Nasal spray




Primary Outcome Measures :
  1. Proportion of COVID-19 positive cases following intervention [ Time Frame: 5 minutes-30 minutes ]
    Proportion of COVID-19 positive cases following intervention in all groups


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 1 minute to 24 hours ]
    Any adverse event following administration of both intervention and placebo agent



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04549376


Contacts
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Contact: Mostafa Kamal Arefin, MBBS,FCPS +8801671748866 arefin61dmc@gmail.com
Contact: Mohammad Jahid Hasan, MBBS,MPH +8801757818973 dr.jahid61@gmail.com

Locations
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Bangladesh
Dhaka Medical College Recruiting
Dhaka, Bangladesh, 1000
Contact: Brig. General Dr. AKM Nasir Uddin, MBBS,MPH    +8801715016984    dmch@hospi.dghs.gov.bd   
Contact: Mohammad Jahid Hasan, MBBS,MPH    +8801757818973      
Sponsors and Collaborators
Pi Research Consultancy Center, Bangladesh
Dhaka Medical College
Investigators
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Study Chair: Prof Sk Nurul Fattah Rumi, MBBS, MS Dhaka Medical College
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Responsible Party: Pi Research Consultancy Center, Bangladesh
ClinicalTrials.gov Identifier: NCT04549376    
Other Study ID Numbers: PiRCC-1131-2020
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After completion of the project, a manuscript will be prepared and will be shared to the journal authority for publication. Data will be shared with the journal authority and make public as part of the publication.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 6 months
Access Criteria: Available on public domain like figshare, researchgate and others

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pi Research Consultancy Center, Bangladesh:
COVID19
prevention
Povidone Iodine
Low and middle income countries
Additional relevant MeSH terms:
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Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes