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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Povidone-Iodine
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2, Povidone Iodine decolonization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Poitiers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Decolonization

Control

Arm Description

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.

Absence of local decolonization

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal carriage
Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal cell cultures
Thyroid tests at Day0 and Day7
Patient satisfaction at Day7 using a numerical comfort scale, graduated from 0 (any discomfort) to 10 (maximum possible discomfort)
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
Need for ward or intensive care hospitalization

Full Information

First Posted
April 29, 2020
Last Updated
October 23, 2020
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04371965
Brief Title
Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With COVID-19
Acronym
KILLER
Official Title
Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With SARS-CoV-2
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
October 23, 2020 (Actual)
Study Completion Date
October 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS-CoV-2, Povidone Iodine decolonization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled open label trial, parallel design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decolonization
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Absence of local decolonization
Intervention Type
Drug
Intervention Name(s)
Povidone-Iodine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day7
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal carriage
Time Frame
Day0, Day1, Day3, Day5 and Day7
Title
Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal cell cultures
Time Frame
Day0, Day1, Day3, Day5 and Day7
Title
Thyroid tests at Day0 and Day7
Time Frame
Day0 and Day7
Title
Patient satisfaction at Day7 using a numerical comfort scale, graduated from 0 (any discomfort) to 10 (maximum possible discomfort)
Time Frame
Day7
Title
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
Time Frame
Day0, Day1, Day3, Day5 and Day7
Title
Need for ward or intensive care hospitalization
Time Frame
Day0, Day1, Day3, Day5 and Day7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital of Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33538761
Citation
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.
Results Reference
derived

Learn more about this trial

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

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