Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With COVID-19

NCT04371965 | Completed Phase 2

• 1 other identifier: KILLER
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The SARS-CoV-2 coronavirus pandemic is responsible for more than 180,000 deaths worldwide and 20,000 deaths in France. To date, no treatment or vaccine has been successful. Povidone-iodine is an antiseptic suitable for use on the skin and mucosa with potent virucidal activity, particularly against coronaviruses. It is marketed for oro-nasopharyngeal decolonization. 24 patients with positive nasopharyngeal SARS-CoV-2 carriage will be randomized (1:1) in an experimental group (benefiting from povidone iodine decolonization) or a control group. Patients in the experimental group will be asked to gargle with a 1% povidone-iodine solution, spray their nose with the same antiseptic solution, and finally applied 10% povidone-iodine cream in each nostril, all four times a day for five days. Patients will be followed for 7 days to evaluate the efficacy and safety of povidone iodine decolonization.

Conditions

COVID-19

Keywords

SARS-CoV-2; Povidone Iodine decolonization

Outcome Measures

Primary Outcomes (1)

• Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day7

  Day 7

Secondary Outcomes (6)

• Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal carriage

  Day0, Day1, Day3, Day5 and Day7

• Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal cell cultures

  Day0, Day1, Day3, Day5 and Day7

• Thyroid tests at Day0 and Day7

  Day0 and Day7

• Patient satisfaction at Day7 using a numerical comfort scale, graduated from 0 (any discomfort) to 10 (maximum possible discomfort)

  Day7

• Daily presence of clinical signs in favour of COVID-19, including respiratory distress using NYHA scale, chest pain, anosmia, agueusia, tiredness, cough, stiffness, nasal congestion, dysphagia and diarrhea

  Day0, Day1, Day3, Day5 and Day7

Study Arms (2)

Decolonization

EXPERIMENTAL

1% Povidone iodine mouthwash (95 mL), gargle, and nasal spray (2,5 mL by nostril), and 10% nasal gel (one drop). All four time a day for five days.

Drug: Povidone-Iodine

Control

NO INTERVENTION

Absence of local decolonization

Interventions

Povidone-Iodine DRUG

Patients in the experimental group will be asked to gargle with a 1% povidone-iodine solution, spray their nose with the same antiseptic solution, and finally applied 10% povidone-iodine cream in each nostril, all four times a day for five days.

Decolonization

Eligibility Criteria

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

You may qualify if:

• Adults (age over 18 yrs) of both sexes
• With positive SARS-CoV-2 carriage by RT-PCR
• Having given their written consent after having been informed

You may not qualify if:

• Patient with low viral load (threshold cycle \[Ct\] \> 25 per RT-PCR),
• Patient unable to perform oro-nasopharyngeal decolonization
• Known hypersensitivity to one of the constituents, particularly to povidone-iodine,
• History of dysthyroidism,
• Known coagulopathy,
• Participation in another clinical trial aimed at reducing viral load in patients with SARS-CoV-2,
• Pregnant or breastfeeding women, or women of childbearing age without effective contraception
• Patients not covered by a social security scheme
• Patients with enhanced protection

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

University Hospital of Poitiers

Poitiers, 86021, France

Location

Related Publications (1)

• Guenezan J, Garcia M, Strasters D, Jousselin C, Leveque N, Frasca D, Mimoz O. Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Nasopharyngeal Viral Load in Patients With COVID-19: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Apr 1;147(4):400-401. doi: 10.1001/jamaoto.2020.5490.

  PMID: 33538761 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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled open label trial, parallel design

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: September 1, 2020
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-07

Locations

FR (1)