COVID-19
Conditions
Keywords
SARS-CoV-2, Povidone Iodine decolonization
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.
Interventions
DRUGPovidone-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.
Sponsors
Poitiers University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled open label trial, parallel design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day7 | Day 7 |
Secondary
| Measure | Time frame |
|---|---|
| Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal cell cultures | Day0, Day1, Day3, Day5 and Day7 |
| Thyroid tests at Day0 and Day7 | Day0 and Day7 |
| Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal carriage | Day0, Day1, Day3, Day5 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 | Day0, Day1, Day3, Day5 and Day7 |
| Need for ward or intensive care hospitalization | 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) | Day7 |
Countries
France
Outcome results
None listed