COVID-19Phase 2NCT05239598

Povidone-Iodine Oral Rinse Study

A Phase 2 study testing Mouth rinse in people with COVID-19, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a two-arm, randomized, 2-phase study. Phase I will be double blinded clinical trial of the safety and efficacy of an antiseptic mouthwash solution on reducing SARS-CoV-2 load in COVID 19+ adult individuals. Phase II is designed as an open label trial, and all subjects will receive the active mouthwash. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: Mouth rinse
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 7 Feb 2022to 13 Jul 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able and willing to provide informed consent prior to initiation of study procedures.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Male or female, aged 18 years and older.
Clinical diagnosis of COVID-19 infection confirmed with a positive point of care test.
Confirmed diagnosis within 5 days of baseline visit (within 5 days of COVID-19 test) and at least one clinical COVID-19 symptom [*Signs and symptoms of COVID-19 present at illness onset vary, but over the course of the disease, most people will experience the following: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste of smell, sore throat, congestion or runny nose, nausea or vomiting and diarrhea.]
Presents with a minimum of six natural teeth.

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Ability to rinse/gargle with study products.
Not using mouth rinse/gargling solutions at the time of enrollment.
Not taking antimicrobial medications (antibacterial, antiviral, antibiotics, including hydroxychloroquine) at time of enrollment.
Ability to participate in the study and come to site during Phase I of the study for collection of swabs and saliva.
Willing to use an acceptable method of birth control throughout duration of the study. Acceptable methods include hormonal contraceptives, barrier methods, abstinence, or other effective methods approved by the PI.
If continuing to Phase II of the trial, ability to continue using study products for 1 week (+ 3 days). (Participants do not have to agree to participate in Phase II in order to participate in Phase I.)
If continuing to Phase II of the trial, agree to receive text messages/phone calls containing questionnaires regarding compliance and use of study product, and reminders, able to complete virtual follow-up study visit for collection of outcomes data.

Who cannot join

Individuals receiving antiviral medications
Pregnant or breastfeeding women (for premenopausal women of childbearing potential, pregnancy status to be confirmed through a urine pregnancy test during the study visit)
Inability to comply with study protocol
Having an allergy to any of the study mouthwash ingredients
Having any thyroid condition.
Presents with a current suspicious oral lesion at the examiner's discretion, and/or currently undergoing radiation therapy for head or neck cancer, and/or has received radiation therapy to the head or neck (including radioactive iodine therapy).

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

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About this study

Official title: A Phase II, Randomized Trial to Test the Effect of Povidone-iodine 0.5% as Mouthwash/Gargle on SARS-CoV-2 Load (COVID 19) as an Adjuvant Infection Control Measure in Dental Practice

Conditions: COVID-19
Being tested: Mouth 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.

Mouth rinseDrug
Subjects will be asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.

Study groups in NCT05239598
Study group	Role	What they receive
Povidone-iodine 0.5% antiseptic mouth rinse	Experimental	Subjects will be asked to rinse/gargle one time with 10 mL of Povidone-iodine 0.5% antiseptic mouth rinse for 30 seconds. Receives: Drug: Mouth rinse
Placebo	Placebo comparator	Subjects will be asked to rinse/gargle one time with 10 mL of placebo mouth rinse for 30 seconds. Receives: Drug: Mouth rinse

What is being measured

The primary outcome is the main question the study is designed to answer.

[PCR Saliva] Percent Change From Baseline Ct Viral Targets
The primary endpoint is the percentage reduction of SARS-Co-V-2 load in saliva at 60 minutes (post-intervention) compared to baseline between the PVP-I mouthwash versus the placebo mouthwash. For this outcome, Cycle Threshold is a proxy for SARS-Co-V-2 load. A positive percent change from baseline Cycle Threshold indicates a decrease from baseline SAR-Co-V2.
[Quick SARS-CoV-2 rRT-PCR Kit (Zymo Research, Cat. No. R3011)].
Measured: 60 minutes after intervention

Secondary outcomes (1)

[PCR Saliva] Percent Change From Baseline Cycle Threshold at 5 and 30 Minutes Post Intervention
The secondary endpoints are the percentage reduction of SARS-Co-V-2 load in saliva at 5 and 30 minutes (post-intervention) compared to baseline between the PVP-I mouthwash versus the placebo mouthwash. For this outcome, Cycle Threshold is a proxy for SARS-Co-V-2 load. A positive percent change from baseline Cycle Threshold indicated a decrease from baseline SARS-Co-V-2.
Measured: 5 and 30 minutes post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Feb 202213 Jul 2022

First posted15 Feb 2022
Study start7 Feb 2022
Primary completion7 Jul 2022
Study completion13 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05239598
Sponsor's protocol ID: 849386
Status last verified: Jul 2023
First submitted: 14 Feb 2022
Last updated: 14 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized Trial to Test the Effect of Povidone-iodine 0.5% as Mouthwash/Gargle on SARS-CoV-2 Load (COVID 19) as an Adjuvant Infection Control Measure in Dental Practice
ClinicalTrials.gov ID: NCT05239598
Acronym / sponsor ID: 849386
Conditions: COVID-19
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Avrio Health
Study start: 7 Feb 2022 (actual)
Primary completion: 7 Jul 2022 (actual)
Study completion: 13 Jul 2022 (actual)
First posted: 15 Feb 2022 (actual)
Results: Posted 14 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Povidone-iodine 0.5% antiseptic mouth rinse	Experimental	Drug: Mouth rinseSubjects will be asked to rinse/gargle one time with 10 mL of Povidone-iodine 0.5% antiseptic mouth rinse for 30 seconds.
Placebo	Placebo comparator	Drug: Mouth rinseSubjects will be asked to rinse/gargle one time with 10 mL of placebo mouth rinse for 30 seconds.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Able and willing to provide informed consent prior to initiation of study procedures.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Male or female, aged 18 years and older.
Clinical diagnosis of COVID-19 infection confirmed with a positive point of care test.
Confirmed diagnosis within 5 days of baseline visit (within 5 days of COVID-19 test) and at least one clinical COVID-19 symptom [*Signs and symptoms of COVID-19 present at illness onset vary, but over the course of the disease, most people will experience the following: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste of smell, sore throat, congestion or runny nose, nausea or vomiting and diarrhea.]

Key exclusion criteria (6 listed)

Individuals receiving antiviral medications
Pregnant or breastfeeding women (for premenopausal women of childbearing potential, pregnancy status to be confirmed through a urine pregnancy test during the study visit)
Inability to comply with study protocol
Having an allergy to any of the study mouthwash ingredients
Having any thyroid condition.

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
Mouth rinseSubjects will be asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.	Drug	Placebo, Povidone-iodine 0.5% antiseptic mouth rinse

Primary outcome

[PCR Saliva] Percent Change From Baseline Ct Viral Targets
Time frame: 60 minutes after intervention
The primary endpoint is the percentage reduction of SARS-Co-V-2 load in saliva at 60 minutes (post-intervention) compared to baseline between the PVP-I mouthwash versus the placebo mouthwash. For this outcome, Cycle Threshold is a proxy for SARS-Co-V-2 load. A positive percent change from baseline Cycle Threshold indicates a decrease from baseline SAR-Co-V2. [Quick SARS-CoV-2 rRT-PCR Kit (Zymo Research, Cat. No. R3011)].

1 secondary outcome

[PCR Saliva] Percent Change From Baseline Cycle Threshold at 5 and 30 Minutes Post Intervention
Time frame: 5 and 30 minutes post-intervention

Results and safety

Results posted to the registry on 14 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Povidone-iodine 0.5% Antiseptic Mouth Rinse	21	21
Placebo	19	19

Primary outcome: [PCR Saliva] Percent Change From Baseline Ct Viral Targets

Time frame: 60 minutes after intervention. Mean (95% Confidence Interval). Unit: % Change from Baseline Cycle Threshold

Measure	Povidone-iodine 0.5% Antiseptic Mouth Rinse n = 19	Placebo n = 17
Value	5.8 (0.8 to 10.7)	1.3 (-6.2 to 8.8)

Povidone-iodine 0.5% Antiseptic Mouth Rinse vs Placebo: Mean Difference (Net): 4.5 (95% CI -4.0 to 13.0), p = 0.287, t-test, 2 sided

Population analysed: Participants were randomized to Povidone-iodine or Placebo (saline) in a 1:1 ratio. Three participants had non-evaluable baseline Cycle Threshold-values and one value was missing at 60 minutes so they were excluded from the analysis of the outcome.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were recorded from the time of informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Note, no SAEs were reported.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Povidone-iodine 0.5% Antiseptic Mouth Rinse	0 of 20 (0%)	0 of 40 (0%)	0 of 20
Placebo	0 of 20 (0%)	0 of 40 (0%)	0 of 20
Phase II - Open Label	0 of 37 (0%)	4 of 37 (10.8%)	0 of 37

Limitations and caveats (from the sponsor): Our findings suggest that RT-PCR quantification of Ct viral targets present some limitations but can be of clinical utility. RT-PCR methods are inherently quantitative, and reproducible during repeated clinical sampling over a short time period. A limitation of our study was that changes in viral targets (RT-PCR) was determined after a one-time use of the mouthwash; prolonged use might yield better efficacy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Patricia Corby, DDS, MS principal investigator

University of Pennsylvania

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 Mouth rinse in people with COVID-19, run by University of Pennsylvania 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 13 inclusion and 6 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: finished, as of the sponsor's last update on 14 Aug 2023. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

[PCR Saliva] Percent Change From Baseline Ct Viral Targets (time frame: 60 minutes after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05239598.

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 14 Aug 2023.