COVID-19
Conditions
Brief summary
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.
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.
Interventions
DRUGSaline oral/nasal rinse
5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.
DRUG0.5% 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.
DRUG0.12% 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.
Sponsors
NYU Langone Health
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 79 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral load (and/or cycle time to PCR as a proxy for quantitative viral load) in the nasopharynx and oropharynx | 7 days | nasopharyngeal swab for viral PCR will be taken at the end of each day for 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen requirement of the patient | 7 days | Recorded daily |
| Oxygen saturation of the patient | 7 days | Recorded daily |
Countries
United States
Outcome results
None listed