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

COVID-19 Clinical Trial

— KILLER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04371965
• Other study ID #: KILLER
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2020
• Est. completion date: October 23, 2020

Study information

• Verified date: July 2020
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 23, 2020
• Est. primary completion date: October 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital of Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day7		Day 7
Secondary	Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal carriage		Day0, Day1, Day3, Day5 and Day7
Secondary	Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal cell cultures		Day0, Day1, Day3, Day5 and Day7
Secondary	Thyroid tests at Day0 and Day7		Day0 and Day7
Secondary	Patient satisfaction at Day7 using a numerical comfort scale, graduated from 0 (any discomfort) to 10 (maximum possible discomfort)		Day7
Secondary	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
Secondary	Need for ward or intensive care hospitalization		Day0, Day1, Day3, Day5 and Day7