Clinical trial NCT04371965: Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With COVID-19
Official title: Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With SARS-CoV-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: SARS-CoV-2
Povidone Iodine decolonization
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled open label trial, parallel design
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day7
timeFrame: Day 7
Secondary outcomes:
measure: Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal carriage
timeFrame: Day0, Day1, Day3, Day5 and Day7
measure: Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal cell cultures
timeFrame: Day0, Day1, Day3, Day5 and Day7
measure: Thyroid tests at Day0 and Day7
timeFrame: Day0 and Day7
measure: Patient satisfaction at Day7 using a numerical comfort scale, graduated from 0 (any discomfort) to 10 (maximum possible discomfort)
timeFrame: Day7
measure: 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
timeFrame: Day0, Day1, Day3, Day5 and Day7
measure: Need for ward or intensive care hospitalization
timeFrame: Day0, Day1, Day3, Day5 and Day7
Other outcomes:
Locations:
city: Poitiers
country: France
facility: University Hospital of Poitiers
Study officials:
References:
citation: Guenezan J, Garcia M, Strasters D, Jousselin C, Leveque N, Frasca D, Mimoz O. Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Nasopharyngeal Viral Load in Patients With COVID-19: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Apr 1;147(4):400-401. doi: 10.1001/jamaoto.2020.5490.