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Completed

NCT Number: NCT04371965

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital of Poitiers

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Povidone-Iodine

Drug

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 outcomes

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

    Time frame: Day 7

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: KILLER

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 1, 2020
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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