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

Sponsor

Poitiers University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04371965

Collaborator

(none)

Enrollment

Location

Arms

1.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Povidone-Iodine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled open label trial, parallel designRandomized controlled open label trial, parallel design

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Actual Primary Completion Date :

Oct 23, 2020

Actual Study Completion Date :

Oct 23, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day7 [Day 7]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Poitiers	Poitiers		France	86021

Sponsors and Collaborators

Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Poitiers University Hospital

ClinicalTrials.gov Identifier:

NCT04371965

Other Study ID Numbers:

KILLER

First Posted:

May 1, 2020

Last Update Posted:

Oct 26, 2020

Last Verified:

Jul 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Poitiers University Hospital

SARS-CoV-2

Povidone Iodine decolonization

Additional relevant MeSH terms:

COVID-19

Povidone-Iodine

Povidone

Study Results

No Results Posted as of Oct 26, 2020