Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With COVID-19 (KILLER)
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|ClinicalTrials.gov Identifier: NCT04371965|
Recruitment Status : Not yet recruiting
First Posted : May 1, 2020
Last Update Posted : May 1, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled open label trial, parallel design|
|Masking:||None (Open Label)|
|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|
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.
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
- Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day7 [ Time Frame: Day 7 ]
- Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal carriage [ 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 ]
- Thyroid tests at Day0 and Day7 [ Time Frame: Day0 and Day7 ]
- Patient satisfaction at Day7 using a numerical comfort scale, graduated from 0 (any discomfort) to 10 (maximum possible discomfort) [ Time Frame: 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 ]
- Need for ward or intensive care hospitalization [ Time Frame: Day0, Day1, Day3, Day5 and Day7 ]
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
|Contact: Olivier MIMOZ, Professor||0549444600 ext +firstname.lastname@example.org|
|Contact: Sabrina SEGUIN, CRA||0549443229 ext +email@example.com|