COVID-19Early Phase 1SHIELDNCT04478019
SHIELD Study: Using Naso-oropharyngeal Antiseptic Decolonization to Reduce COVID-19 Viral Shedding
A Early Phase 1 study testing 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse in people with COVID-19 and SARS-CoV 2, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Essential workers in positions with increased likelihood of exposure to SARS-CoC-2 will be most impacted by the proposed project. Evidence has shown that the SARS-CoV-2 novel coronavirus is easily transmissable through close contact between individuals, especially during aerosol-generating procedures such as… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV 2
- What is being tested?
- 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2020to 30 Jun 2022
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is a essential worker performing at least some in-person job duties (not 100% remote)
- Participant is willing and able to perform intervention and data collection procedures.
- Participant is able to provide informed consent in English language.
Who cannot join
- Diagnosis of COVID-19 within 2 months prior to enrollment, or active respiratory illness symptoms at time of enrollment
- Known medical contraindication to chlorhexidine gluconate or povidone-iodine treatment ingredients (such as a known allergy)
- Participant has a known medical and/or surgical reason prohibiting nasal swab sampling.
- Participant is female who is pregnant, or believes she may be pregnant, at time of enrollment.
- Participant is actively taking/using any treatments or interventions as part of any other COVID-19 related investigational trials.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53705
About this study
Official title: Role of NaSo-oropHaryngeal Antiseptic dEcolonizaiton to Reduce Covid-19 Viral Shedding and Disease Transmission: SHIELD Study
Essential workers in positions with increased likelihood of exposure to SARS-CoC-2 will be most impacted by the proposed project. Evidence has shown that the SARS-CoV-2 novel coronavirus is easily transmissable through close contact between individuals, especially during aerosol-generating procedures such as intubation of patients. The intervention proposed in this study (nasal and oral decontamination with povidone-iodine and chlorhexidine, respectively) presents an opportunity for a safe, effective, and feasible treatment to decontaminate the primary entry points for SARS-CoV-2. As such, the intervention to be studied in this project may protect healthcare and other essential workers by preventing transmission of SARS-CoV-2 from patients to healthcare workers, as well as the general public to essential worker,. and thus reducing the incidence of COVID-19 in these workers.
- Conditions
- COVID-19, SARS-CoV 2
- Being tested
- 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse
- Keywords
- COVID-19, povidone-iodine, chlorhexidine gluconate, transmission, virology
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinseDrug
2 swab sticks of 10% povidone-iodine in each nares and 0.12% CHG oral rinse
| Study group | Role | What they receive |
|---|---|---|
| Control > Active Intervention | Other | Treatment is 3 weeks of standard personal protective equipment without any povidone-iodine (PI) or chlorhexidine gluconate (CHG) intervention (control), followed by a 2 weeks washout period, and 3 weeks of nasal (10% povidone-iodine swab sticks in each nostril) and CHG oral decolonization (swish and spit 15 ml 0.12% CHG oral rinse for 30 seconds, four times/day) procedures. Receives: Drug: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse |
| Active Intervention > Control | Other | Treatment is 3 weeks of nasal (10% povidone-iodine swab sticks in each nostril) and CHG oral decolonization (swish and spit 15 ml 0.12% CHG oral rinse for 30 seconds, four times/day) procedures, followed by 2 weeks of washout, and 3 weeks of standard personal protective equipment without any PI or CHG intervention (control). Receives: Drug: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with COVID-19 diagnosis
Participants will be monitored for positive COVID-19 test results during this trial
Measured: 8 weeks
SARS-Cov-2 Viral Load
Viral load will be measured as a continuous outcome for each participant (three times per week) throughout this trial.
Measured: 8 weeks
Secondary outcomes (2)
Fidelity of the treatment regimen
Assessment of fidelity (as measured by percentage of compliance) to the treatment regimen will be measured by participants' reporting of intervention doses take through a daily treatment diary.
Measured: 8 weeks
Feasibility of the treatment regimen
A survey asking subjects to rank several factors that contribute to overall feasibility of use will be given pre- and post-intervention treatment.
Measured: 2 weeks total: 1 week (pre-intervention) and 1 week after completion of intervention (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start7 Jul 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two-period cross-over trial with a wash-out period between two study intervention periods. Participants will be randomized in a 1:1 ratio to two intervention sequences: active intervention followed by a no intervention control; or no intervention control followed by active intervention
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478019
- Sponsor's protocol ID
- 2020-0540
- Other IDs
- A534265, SMPH/MEDICINE/INFECT DIS, Protocol Version 6/1/2020
- Acronym
- SHIELD
- Status last verified
- Jul 2022
- First submitted
- 15 Jul 2020
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study results will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of NaSo-oropHaryngeal Antiseptic dEcolonizaiton to Reduce Covid-19 Viral Shedding and Disease Transmission: SHIELD Study
- ClinicalTrials.gov ID
- NCT04478019
- Acronym / sponsor ID
- SHIELD / 2020-0540
- Conditions
- COVID-19, SARS-CoV 2
- Keywords
- COVID-19, povidone-iodine, chlorhexidine gluconate, transmission, virology
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 20 Jul 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.
Essential workers in positions with increased likelihood of exposure to SARS-CoC-2 will be most impacted by the proposed project. Evidence has shown that the SARS-CoV-2 novel coronavirus is easily transmissable through close contact between individuals, especially during aerosol-generating procedures such as intubation of patients. The intervention proposed in this study (nasal and oral decontamination with povidone-iodine and chlorhexidine, respectively) presents an opportunity for a safe, effective, and feasible treatment to decontaminate the primary entry points for SARS-CoV-2. As such, the intervention to be studied in this project may protect healthcare and other essential workers by preventing transmission of SARS-CoV-2 from patients to healthcare workers, as well as the general public to essential worker,. and thus reducing the incidence of COVID-19 in these workers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-period cross-over trial with a wash-out period between two study intervention periods. Participants will be randomized in a 1:1 ratio to two intervention sequences: active intervention followed by a no intervention control; or no intervention control followed by active intervention
| Arm | Type | Receives |
|---|---|---|
| Control > Active Intervention | Other | Drug: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinseTreatment is 3 weeks of standard personal protective equipment without any povidone-iodine (PI) or chlorhexidine gluconate (CHG) intervention (control), followed by a 2 weeks washout period, and 3 weeks of nasal (10% povidone-iodine swab sticks in each nostril) and CHG oral decolonization (swish and spit 15 ml 0.12% CHG oral rinse for 30 seconds, four times/day) procedures. |
| Active Intervention > Control | Other | Drug: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinseTreatment is 3 weeks of nasal (10% povidone-iodine swab sticks in each nostril) and CHG oral decolonization (swish and spit 15 ml 0.12% CHG oral rinse for 30 seconds, four times/day) procedures, followed by 2 weeks of washout, and 3 weeks of standard personal protective equipment without any PI or CHG intervention (control). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant is a essential worker performing at least some in-person job duties (not 100% remote)
- Participant is willing and able to perform intervention and data collection procedures.
- Participant is able to provide informed consent in English language.
Key exclusion criteria (5 listed)
- Diagnosis of COVID-19 within 2 months prior to enrollment, or active respiratory illness symptoms at time of enrollment
- Known medical contraindication to chlorhexidine gluconate or povidone-iodine treatment ingredients (such as a known allergy)
- Participant has a known medical and/or surgical reason prohibiting nasal swab sampling.
- Participant is female who is pregnant, or believes she may be pregnant, at time of enrollment.
- Participant is actively taking/using any treatments or interventions as part of any other COVID-19 related investigational trials.
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 |
|---|---|---|
| 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse2 swab sticks of 10% povidone-iodine in each nares and 0.12% CHG oral rinse | Drug | Active Intervention > Control, Control > Active Intervention |
Primary outcome
Number of Participants with COVID-19 diagnosis
Time frame: 8 weeks
Participants will be monitored for positive COVID-19 test results during this trial
SARS-Cov-2 Viral Load
Time frame: 8 weeks
Viral load will be measured as a continuous outcome for each participant (three times per week) throughout this trial.
2 secondary outcomes
Fidelity of the treatment regimen
Time frame: 8 weeks
Feasibility of the treatment regimen
Time frame: 2 weeks total: 1 week (pre-intervention) and 1 week after completion of intervention (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Individual participant dataSharing planned: Yes. De-identified study results will be shared with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse in people with COVID-19 and SARS-CoV 2, run by University of Wisconsin, Madison 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: finished, as of the sponsor's last update on 14 Jul 2022. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with COVID-19 diagnosis (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 14 Jul 2022.