COVID-19Phase 2KILLERNCT04371965
Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With COVID-19
A Phase 2 study testing Povidone-Iodine in people with COVID-19, run by Poitiers University Hospital at 1 site in France.
Trial summary
The SARS-CoV-2 coronavirus pandemic is responsible for more than 180,000 deaths worldwide and 20,000 deaths in France. To date, no treatment or vaccine has been successful. Povidone-iodine is an antiseptic suitable for use on the skin and mucosa with potent virucidal activity, particularly against coronaviruses. 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?
- Povidone-Iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 23 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age over 18 yrs) of both sexes
- With positive SARS-CoV-2 carriage by RT-PCR
- Having given their written consent after having been informed
Who cannot join
- Patient with low viral load (threshold cycle [Ct] > 25 per RT-PCR),
- Patient unable to perform oro-nasopharyngeal decolonization
- Known hypersensitivity to one of the constituents, particularly to povidone-iodine,
- History of dysthyroidism,
- Known coagulopathy,
- Participation in another clinical trial aimed at reducing viral load in patients with SARS-CoV-2,
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- Pregnant or breastfeeding women, or women of childbearing age without effective contraception
- Patients not covered by a social security scheme
- Patients with enhanced protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With SARS-CoV-2
The SARS-CoV-2 coronavirus pandemic is responsible for more than 180,000 deaths worldwide and 20,000 deaths in France. To date, no treatment or vaccine has been successful. Povidone-iodine is an antiseptic suitable for use on the skin and mucosa with potent virucidal activity, particularly against coronaviruses. It is marketed for oro-nasopharyngeal decolonization.
24 patients with positive nasopharyngeal SARS-CoV-2 carriage will be randomized (1:1) in an experimental group (benefiting from povidone iodine decolonization) or a control group. Patients in the experimental group will be asked to gargle with a 1% povidone-iodine solution, spray their nose with the same antiseptic solution, and finally applied 10% povidone-iodine cream in each nostril, all four times a day for five days. Patients will be followed for 7 days to evaluate the efficacy and safety of povidone iodine decolonization.
- Conditions
- COVID-19
- Being tested
- Povidone-Iodine
- Keywords
- SARS-CoV-2, Povidone Iodine decolonization
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-IodineDrug
Patients in the experimental group will be asked to gargle with a 1% povidone-iodine solution, spray their nose with the same antiseptic solution, and finally applied 10% povidone-iodine cream in each nostril, all four times a day for five days.
| Study group | Role | What they receive |
|---|---|---|
| Decolonization | Experimental | 1% Povidone iodine mouthwash (95 mL), gargle, and nasal spray (2,5 mL by nostril), and 10% nasal gel (one drop). All four time a day for five days. Receives: Drug: Povidone-Iodine |
| Control | No intervention | Absence of local decolonization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day7
Measured: Day 7
Secondary outcomes (6)
Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal carriage
Measured: Day0, Day1, Day3, Day5 and Day7
Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal cell cultures
Measured: Day0, Day1, Day3, Day5 and Day7
Thyroid tests at Day0 and Day7
Measured: Day0 and Day7
Patient satisfaction at Day7 using a numerical comfort scale, graduated from 0 (any discomfort) to 10 (maximum possible discomfort)
Measured: Day7
Daily presence of clinical signs in favour of COVID-19, including respiratory distress using NYHA scale, chest pain, anosmia, agueusia, tiredness, cough, stiffness, nasal congestion, dysphagia and diarrhea
Measured: Day0, Day1, Day3, Day5 and Day7
Need for ward or intensive care hospitalization
Measured: Day0, Day1, Day3, Day5 and Day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start1 Sep 2020
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371965
- Sponsor's protocol ID
- KILLER
- Acronym
- KILLER
- Status last verified
- Jul 2020
- First submitted
- 29 Apr 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guenezan J, Garcia M, Strasters D, Jousselin C, Leveque N, Frasca D, Mimoz O. Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Nasopharyngeal Viral Load in Patients With COVID-19: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Apr 1;147(4):400-401. doi: 10.1001/jamaoto.2020.5490.
PubMed 33538761
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04371965
- Acronym / sponsor ID
- KILLER / KILLER
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, Povidone Iodine decolonization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 1 May 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.
The SARS-CoV-2 coronavirus pandemic is responsible for more than 180,000 deaths worldwide and 20,000 deaths in France. To date, no treatment or vaccine has been successful. Povidone-iodine is an antiseptic suitable for use on the skin and mucosa with potent virucidal activity, particularly against coronaviruses. It is marketed for oro-nasopharyngeal decolonization.
24 patients with positive nasopharyngeal SARS-CoV-2 carriage will be randomized (1:1) in an experimental group (benefiting from povidone iodine decolonization) or a control group. Patients in the experimental group will be asked to gargle with a 1% povidone-iodine solution, spray their nose with the same antiseptic solution, and finally applied 10% povidone-iodine cream in each nostril, all four times a day for five days. Patients will be followed for 7 days to evaluate the efficacy and safety of povidone iodine decolonization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled open label trial, parallel design
| Arm | Type | Receives |
|---|---|---|
| Decolonization | Experimental | Drug: Povidone-Iodine1% Povidone iodine mouthwash (95 mL), gargle, and nasal spray (2,5 mL by nostril), and 10% nasal gel (one drop). All four time a day for five days. |
| Control | No intervention | –Absence of local decolonization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (age over 18 yrs) of both sexes
- With positive SARS-CoV-2 carriage by RT-PCR
- Having given their written consent after having been informed
Key exclusion criteria (9 listed)
- Patient with low viral load (threshold cycle [Ct] > 25 per RT-PCR),
- Patient unable to perform oro-nasopharyngeal decolonization
- Known hypersensitivity to one of the constituents, particularly to povidone-iodine,
- History of dysthyroidism,
- Known coagulopathy,
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 |
|---|---|---|
| Povidone-IodinePatients in the experimental group will be asked to gargle with a 1% povidone-iodine solution, spray their nose with the same antiseptic solution, and finally applied 10% povidone-iodine cream in each nostril, all four times a day for five days. | Drug | Decolonization |
Primary outcome
Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day7
Time frame: Day 7
6 secondary outcomes
Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal carriage
Time frame: Day0, Day1, Day3, Day5 and Day7
Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal cell cultures
Time frame: Day0, Day1, Day3, Day5 and Day7
Thyroid tests at Day0 and Day7
Time frame: Day0 and Day7
Patient satisfaction at Day7 using a numerical comfort scale, graduated from 0 (any discomfort) to 10 (maximum possible discomfort)
Time frame: Day7
Daily presence of clinical signs in favour of COVID-19, including respiratory distress using NYHA scale, chest pain, anosmia, agueusia, tiredness, cough, stiffness, nasal congestion, dysphagia and diarrhea
Time frame: Day0, Day1, Day3, Day5 and Day7
Need for ward or intensive care hospitalization
Time frame: Day0, Day1, Day3, Day5 and Day7
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 26 Oct 2020.
- Derived from this study: PubMed 33538761Guenezan J, Garcia M, Strasters D, Jousselin C, Leveque N, Frasca D, Mimoz O. Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Nasopharyngeal Viral Load in Patients With COVID-19: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Apr 1;147(4):400-401. doi: 10.1001/jamaoto.2020.5490.
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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 Phase 2 study testing Povidone-Iodine in people with COVID-19, run by Poitiers University Hospital at 1 site in France.
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 9 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 26 Oct 2020. 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 France. 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 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?
Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day7 (time frame: Day 7). 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 NCT04371965, which also lists 1 linked publication.
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 26 Oct 2020.