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

Poitiers University Hospital

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: Povidone-Iodine

Study type: Interventional

Funder types: Other

Identifiers

NCT04371965

KILLER

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Decolonization

Experimental group

Description:

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.

Treatment:

Drug: Povidone-Iodine

Control

No Intervention group

Description:

Absence of local decolonization