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Purpose

For this study, 48 patients who have been diagnosed with COVID-19 will be randomly assigned to four study groups: control, saline, chlorhexidine gluconate, and povidone-iodine. Each patient will be asked to gargle with a solution of either saline, chlorhexidine gluconate, or povidone-iodine or nothing (control group) as well as spray the same solution in their nose four times daily. Patients will then be tested for COVID-19 once daily in the evening for 7 days and viral loads will be measured.

Condition

Eligibility

Eligible Ages
Between 18 Years and 79 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Positive test for COVID-19 2. Age 18-79 years 3. Willing and able to perform oral gargles and nasal rinses four times daily

Exclusion Criteria

  1. Requiring mechanical ventilation 2. Unable or unwilling to perform oral gargles and nasal rinses four times daily 3. History of chronic upper respiratory tract disease 4. Known iodine allergy 5. History of thyroid disease

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized controlled open label trial, parallel design
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Control
Experimental
Saline oral/nasal rinse
  • Drug: Saline oral/nasal rinse
    5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.
Experimental
0.5% Povidone/Iodine oral/nasal rinse
  • Drug: 0.5% Povidone/Iodine oral/nasal rinse
    5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.
Experimental
0.12% Chlorhexidine oral/nasal rinse
  • Drug: 0.12% Chlorhexidine oral/nasal rinse
    5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.

Recruiting Locations

More Details

NCT ID
NCT04344236
Status
Withdrawn
Sponsor
NYU Langone Health

Detailed Description

COVID-19 has emerged as a worldwide pandemic and there is a strong need for identification of any measures that can be used to treat this illness or reduce its transmission from person to person. Povidone-iodine has been shown to have virucidal properties against multiple viruses including against the virus that causes SARS which is very similar in makeup to the virus causing COVID-19. The investigators hypothesize that 4x daily use of oral gargles and nasal rinses using a povidone iodine solution will help to reduce the viral load in the nasopharynx and oropharynx in patients who are COVID-19+. If this hypothesis is shown to be true this could potentially have an impact on time to recovery of clinical symptoms as well as reduce shedding of the virus by infected patients. A time course of 7 days was chosen in order to recognize a trend in the viral load over time for patients receiving each of the interventions. Chlorhexidine gluconate and saline rinses were chosen as additional treatment arms as these are frequently used for oral and nasal hygiene and their role in affecting viral load is currently unknown.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.