Study Stopped
This study was withdrawn by the institution to minimize risk to patients and staff with regard to COVID-19.
Gargling and Nasal Rinses to Reduce Oro- and Nasopharyngeal Viral Load in Patients With COVID-19
A Phase II, Randomized, Open-label, Single-institution Study of the Effects of Povidone Iodine Oral Gargles and Nasal Rinses on Viral Load in Patients With COVID-19
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2020
Shorter than P25 for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2020
CompletedStudy Start
First participant enrolled
April 9, 2020
CompletedFirst Posted
Study publicly available on registry
April 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2020
CompletedMay 10, 2021
May 1, 2021
22 days
April 8, 2020
May 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Viral load (and/or cycle time to PCR as a proxy for quantitative viral load) in the nasopharynx and oropharynx
nasopharyngeal swab for viral PCR will be taken at the end of each day for 7 days
7 days
Secondary Outcomes (2)
Oxygen requirement of the patient
7 days
Oxygen saturation of the patient
7 days
Study Arms (4)
Control
NO INTERVENTIONSaline oral/nasal rinse
EXPERIMENTAL0.5% Povidone/Iodine oral/nasal rinse
EXPERIMENTAL0.12% Chlorhexidine oral/nasal rinse
EXPERIMENTALInterventions
5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.
5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.
5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.
Eligibility Criteria
You may qualify if:
- Positive test for COVID-19
- Age 18-79 years
- Willing and able to perform oral gargles and nasal rinses four times daily
You may not qualify if:
- Requiring mechanical ventilation
- Unable or unwilling to perform oral gargles and nasal rinses four times daily
- History of chronic upper respiratory tract disease
- Known iodine allergy
- History of thyroid disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Rickert, MD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2020
First Posted
April 14, 2020
Study Start
April 9, 2020
Primary Completion
May 1, 2020
Study Completion
May 9, 2020
Last Updated
May 10, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- Requests should be directed to scott.rickert@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: \[contact information for PI or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.