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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04371965
• Date of registration: 29/04/2020
• Prospective Registration: Yes
• Primary sponsor: Poitiers University Hospital
• Public title: Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With COVID-19 KILLER
• Scientific title: Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With SARS-CoV-2
• Date of first enrolment: September 1, 2020
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04371965
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

COVID-19

Intervention(s)

Drug: Povidone-Iodine

Primary Outcome(s)

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

Secondary Outcome(s)

Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal carriage [Time Frame: Day0, Day1, Day3, Day5 and Day7]

Patient satisfaction at Day7 using a numerical comfort scale, graduated from 0 (any discomfort) to 10 (maximum possible discomfort) [Time Frame: Day7]

Thyroid tests at Day0 and Day7 [Time Frame: Day0 and 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 [Time Frame: Day0, Day1, Day3, Day5 and Day7]

Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal cell cultures [Time Frame: Day0, Day1, Day3, Day5 and Day7]

Need for ward or intensive care hospitalization [Time Frame: Day0, Day1, Day3, Day5 and Day7]

Secondary ID(s)

KILLER

Source(s) of Monetary Support

Please refer to primary and secondary sponsors