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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371965
Recruitment Status : Not yet recruiting
First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day7 [ Time Frame: Day 7 ]

Secondary Outcome Measures :
  1. Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal carriage [ Time Frame: Day0, Day1, Day3, Day5 and Day7 ]
  2. Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal cell cultures [ Time Frame: Day0, Day1, Day3, Day5 and Day7 ]
  3. Thyroid tests at Day0 and Day7 [ Time Frame: Day0 and Day7 ]
  4. Patient satisfaction at Day7 using a numerical comfort scale, graduated from 0 (any discomfort) to 10 (maximum possible discomfort) [ Time Frame: Day7 ]
  5. 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 ]
  6. Need for ward or intensive care hospitalization [ Time Frame: Day0, Day1, Day3, Day5 and Day7 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371965


Contacts
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Contact: Olivier MIMOZ, Professor 0549444600 ext +33 olivier.mimoz@chu-poitiers.fr
Contact: Sabrina SEGUIN, CRA 0549443229 ext +33 sabrina.seguin@chu-poitiers.fr

Locations
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France
University Hospital of Poitiers
Poitiers, France, 86021
Contact: Olivier MIMOZ, Professor    0549444600 ext +33    olivier.mimoz@chu-poitiers.fr   
Contact: Sabrina SEGUIN, CRA    0549443229 ext +33    sabrina.seguin@chu-poitiers.fr   
Sponsors and Collaborators
Poitiers University Hospital
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT04371965    
Other Study ID Numbers: KILLER
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Poitiers University Hospital:
SARS-CoV-2
Povidone Iodine decolonization
Additional relevant MeSH terms:
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Povidone-Iodine
Povidone
Plasma Substitutes
Blood Substitutes
Anti-Infective Agents, Local
Anti-Infective Agents