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

Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With SARS-CoV-2

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Povidone-Iodine

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86021
    • University Hospital of Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decolonization; 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; 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.
No Intervention: Control; Absence of local decolonization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day7	Day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Need for ward or intensive care hospitalization	Day0, Day1, Day3, Day5 and Day7

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): October 23, 2020
• Study Completion (Actual): October 23, 2020

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Povidone Iodine decolonization
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: KILLER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No