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

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: Povidone-Iodine

• Registration Number: NCT04371965
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-30
• Study First Posted: 2020-05-01
• Status Verified: 2020-07
• Study Start: 2020-09-01
• Primary Completion: 2020-10-23
• Study Completion: 2020-10-23
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decolonization	Povidone-Iodine	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day7	Day 7

Secondary Outcome Measures

Name	Time	Method
Need for ward or intensive care hospitalization	Day0, Day1, Day3, Day5 and Day7
Thyroid tests at Day0 and Day7	Day0 and Day7
Patient satisfaction at Day7 using a numerical comfort scale, graduated from 0 (any discomfort) to 10 (maximum possible discomfort)	Day7
Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal carriage	Day0, Day1, Day3, Day5 and Day7
Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal cell cultures	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

Trial Locations

Locations (1)

University Hospital of Poitiers; 🇫🇷 Poitiers, France