COVID-19Phase 2NCT04344236
Gargling and Nasal Rinses to Reduce Oro- and Nasopharyngeal Viral Load in Patients With COVID-19
A Phase 2 study testing Saline oral/nasal rinse, 0.5% Povidone/Iodine oral/nasal rinse and 0.12% Chlorhexidine oral/nasal rinse in people with COVID-19, run by NYU Langone Health at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Saline oral/nasal rinse, 0.5% Povidone/Iodine oral/nasal rinse and 0.12% Chlorhexidine oral/nasal rinse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2020to 9 May 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive test for COVID-19
- Age 18-79 years
- Willing and able to perform oral gargles and nasal rinses four times daily
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Saline oral/nasal rinse, 0.5% Povidone/Iodine oral/nasal rinse, 0.12% Chlorhexidine oral/nasal rinse
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline oral/nasal rinseDrug
5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.
0.5% Povidone/Iodine oral/nasal rinseDrug
5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.
0.12% Chlorhexidine oral/nasal rinseDrug
5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Saline oral/nasal rinse | Experimental | Not described Receives: Drug: Saline oral/nasal rinse |
| 0.5% Povidone/Iodine oral/nasal rinse | Experimental | Not described Receives: Drug: 0.5% Povidone/Iodine oral/nasal rinse |
| 0.12% Chlorhexidine oral/nasal rinse | Experimental | Not described Receives: Drug: 0.12% Chlorhexidine oral/nasal rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (2)
Oxygen requirement of the patient
Recorded daily
Measured: 7 days
Oxygen saturation of the patient
Recorded daily
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start9 Apr 2020
- Primary completion1 May 2020 (estimated)
- Study completion9 May 2020 (estimated)
Why it stopped: This study was withdrawn by the institution to minimize risk to patients and staff with regard to COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled open label trial, parallel design
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Rickert, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344236
- Sponsor's protocol ID
- s20-00444
- Status last verified
- May 2021
- First submitted
- 8 Apr 2020
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04344236
- Acronym / sponsor ID
- s20-00444
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was withdrawn by the institution to minimize risk to patients and staff with regard to COVID-19.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 9 May 2020 (estimated)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized controlled open label trial, parallel design
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Saline oral/nasal rinse | Experimental | Drug: Saline oral/nasal rinse |
| 0.5% Povidone/Iodine oral/nasal rinse | Experimental | Drug: 0.5% Povidone/Iodine oral/nasal rinse |
| 0.12% Chlorhexidine oral/nasal rinse | Experimental | Drug: 0.12% Chlorhexidine oral/nasal rinse |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Positive test for COVID-19
- Age 18-79 years
- Willing and able to perform oral gargles and nasal rinses four times daily
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline oral/nasal rinse5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days. | Drug | Saline oral/nasal rinse |
| 0.5% Povidone/Iodine oral/nasal rinse5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days. | Drug | 0.5% Povidone/Iodine oral/nasal rinse |
| 0.12% Chlorhexidine oral/nasal rinse5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days. | Drug | 0.12% Chlorhexidine oral/nasal rinse |
Primary outcome
Viral load (and/or cycle time to PCR as a proxy for quantitative viral load) in the nasopharynx and oropharynx
Time frame: 7 days
nasopharyngeal swab for viral PCR will be taken at the end of each day for 7 days
2 secondary outcomes
Oxygen requirement of the patient
Time frame: 7 days
Oxygen saturation of the patient
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Rickert, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Saline oral/nasal rinse, 0.5% Povidone/Iodine oral/nasal rinse and 0.12% Chlorhexidine oral/nasal rinse in people with COVID-19, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral load (and/or cycle time to PCR as a proxy for quantitative viral load) in the nasopharynx and oropharynx (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.