Covid19Early Phase 1NCT04449965
Povidone-Iodine Rinses in the Management of COVID-19
A Early Phase 1 study testing Povidone-iodine in people with Covid19, run by St. Paul's Hospital, Canada at 1 site in Canada.
Trial summary
The aim of this study is to determine if Povidone iodine (PVP-I) rinses and throat gargles or a PVP-I gel forming nasal spray compared to a placebo (a treatment that has no physical effect to a person) is an effective treatment for patients diagnosed with COVID-19. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Povidone-iodine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jan 2021to 16 Aug 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years or older
- Patients diagnosed with laboratory-confirmed SARS-CoV-2 and the development of COVID-19 compatible symptoms within the last 72 hours before enrolment
- Do not require hospitalization
Who cannot join
- Sinonasal tumor
- Hypersensitivity to iodine or betadine
- History of thyroid disorder including thyroid cancer, hyperthyroidism and hypothyroidism
- Use of medications for thyroid disorders including thyroxine and carbimazole
- Current use of topical iodine or betadine for another reason
- Participating in any study with therapies directed at COVID-19 that could influence our results
- Are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Topical Povidone-Iodine Rinses in the Management of the Coronavirus Disease 2019 (COVID-19)
The aim of this study is to determine if Povidone iodine (PVP-I) rinses and throat gargles or a PVP-I gel forming nasal spray compared to a placebo (a treatment that has no physical effect to a person) is an effective treatment for patients diagnosed with COVID-19. These patients have been diagnosed with mild/moderate COVID-19 symptoms and sent home for self-isolation. Patients will be instructed to take either of the two treatments or placebo twice daily for two weeks and have follow up visits 2 and 4 weeks after. The participants will also complete study related procedures such as saliva sample collection, and two questionnaires throughout the study period. The investigators hypothesize that COVID 19 positive participants who use either of the Povidone - Iodine treatment will have a reduction in their viral load, develop a negative oral mucosa sample and improve their clinical symptoms.
Read the detailed description
The proposed study is a prospective randomized double blinded placebo-controlled study of 6-weeks in duration. Patients who have tested positive and diagnosed with COVID-19 within the previous 72 h and who meet the inclusion and exclusion criteria, will be invited to participate in this study.
This study will be involving non-hospitalized patients who are recovering at home. One arm will use betadine sinonasal rinses and a betadine mouth gargle while another arm will act as a control receiving a placebo (a food coloring agent). A third arm will use a 0.6% PVP-I gel forming nasal spray twice daily. A baseline saliva sample will be collected to assure a positive COVID-19 test and to quantify viral load. Repeat saliva samples will be collected every 2 days for 2 weeks, then at 4 weeks and 6 weeks to quantify test status and quantify viral load reduction. WURSS-44 questionnaires will be completed daily for 2 weeks and then again at 4 weeks and 6 weeks. SNOT-22 questionnaires will be completed at baseline and then again at 2 weeks, 4 weeks, and 6 weeks. The investigators will also monitor for worsening of symptoms and the need for hospitalization for the entire 6 week duration of the study.
Upon enrolment in the study after obtaining positive results for COVID-19, demographic data and clinical data will be obtained by the investigators. Patients will be randomly assigned to one of the study arms delineated above by permuted block randomization
The clinical samples that detect COVID-19 are obtained by collecting a saliva sample prior to rinsing. This will avoid confounding by artificially lowering the viral particles sampled and will minimize any potentially inhibitory effects of the intervention compounds on lab detection. The sample will be put into a sterile collection container and stored in the fridge until it is transported to the laboratory for analysis.
Sample Size
Considering the quick turnover and the rapid doubling time in the number of positive cases and the unprecedented nature of this study's design and treatment, the investigators hope to recruit 20 patients in each study arm as a pilot study around this subject matter. To account for a drop-out rate of 25% the investigators plan to recruit 27 patients in each arm.
Analysis
Primary outcomes
- Time to a negative/undetectable RT-PCR SARS-CoV-2 saliva sample amongst patients rinsing and gargling with 0.23% PVP-I compared to a placebo group measured during the study treatment daily for 2 weeks and at the 4-week and 6-week mark. 1.1. A Kaplan-Meier curve and log rank test will be used to compare the time to a negative saliva test from the start of the study between patients receiving PVP-I to those receiving the placebo. A hazard ratio of >1 will favor treatment with PVP-I, calculated with a 95% confidence interval by Cox proportional hazards model. 1.2. The median time to negative swab in the PVP-I group versus the control will be statistically compared using the unpaired Mann-Whitney U test. 1.3. The proportion of patients with a negative sample will be compared between the PVP-I group and control group at all times points using the Chi-squared test. 1.4. A subsequent risk factor analysis will be conducted using the cox proportional hazards model, investigating the independent influence of various host and disease factors on the time to a negative sample during the study period. The following relevant factors included in the multivariable regression were identified a priori upon consultation with experienced clinicians at our center: gender, age, smoking status (yes/no), baseline viral load, known baseline lung comorbidity (yes/no) , duration of symptoms before treatment.
- SARS-CoV-2 viral load changes in the saliva amongst patients rinsing and gargling with 0.23% PVP-I compared to a placebo group measured during the study treatment daily for 2 weeks and at the 4-week and 6-week mark. 2.1. Logarithmic viral load levels in the saliva samples will be graphed and compared between the PVP-I and placebo group at all time points using the unpaired Mann-Whitney U test. For complete statistical analysis, a value of 1 log base 10 copies/mL will be assigned to samples with undetectable viral levels.
- Time to a negative/undetectable SARS-CoV-2 saliva sample as well as SARS-CoV-2 viral load changes amongst patients rinsing and gargling with 0.23% PVP-I compared to the 0.6% PVP-I gel forming nasal spray for 2 weeks and at the 4-week and 6-week mark.
3.1. Similar analysis as per 1.1, 1.2, 1.3 and 2.1 above in primary outcomes.
Secondary outcomes
- Change in symptom scores between the PVP-I group and placebo group as assessed by the SNOT-22 scores collected at baseline and at the 2-week, 4-week and 6-week mark. 1.1. SNOT-22 scores will be graphed and compared between baseline and each time point for each group separately using the ANOVA with repeated measures test and Bonferroni post hoc test. 1.2. The change in SNOT-22 scores between baseline and each time point will be compared between groups using the unpaired Mann-Whitney U test.
- Change in symptom scores between the PVP-I group and placebo group as assessed by the WURSS-44 scores collected daily from baseline for 2 weeks and at the 4-week and 6-week mark. 2.1. WURSS-44 scores will be graphed and compared between baseline, the 2 week, 4-week and 6-week marks for each group separately using the ANOVA with repeated measures test and Bonferroni post hoc test. 2.2. WURSS-44 scores will be graphed and compared between baseline and at all time points using the unpaired Mann-Whitney U test.
- The need for hospitalization between the PVP-I group and placebo group. 3.1. The Kaplan-Meier technique will also be used to compare the need for hospitalization from the start of the study between both groups.
- The change in SNOT-22 scores, WURSS-44 scores and the need for hospitalization between patients rinsing and gargling with 0.23% PVP-I compared to the 0.6% PVP-I gel forming nasal spray.
4.1. Similar analysis as per 1.1, 1.2, 2.1, 2.2 and 3.1 above in secondary outcomes.
Descriptive statistics (mean, median, SD) will be used to describe demographic characteristics of the patients. Results will be considered statistically significant with p values < 0.05. All statistical analyzes will be performed using RStudio version 3.4.1 (RStudio, Boston, MA, USA).
Assessment of Safety
Safety Monitoring
Patients who experience signs and symptoms of iodine reaction will be noted and the code will be broken so that a discussion can occur between the research supervisor and the patient regarding the use of the topical iodine.
Patients can contact the office anytime if they notice any of the signs or symptoms of iodine reaction and will be seen by the research supervisor (or designate) within 24 hours.
Adverse Events (AE's)
All expected and unexpected adverse events will be recorded and graded by the research supervisor. Stable chronic conditions, which are present prior to the clinical trial entry and do not worsen, are not considered adverse events and will be accounted for in the patient's medical history.
- Conditions
- Covid19
- Being tested
- Povidone-iodine, Placebo
- Keywords
- Povidone - Iodine, Covid19, Self-Isolation
- 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
Also called Betadine
This will be performed twice daily for two weeks.
PlaceboDrug
This will be performed twice daily for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| PVP-I sinus rinses and throat gargles | Experimental | Participants will dilute 7 mL of 10% PVP-I into 300 mL of saline for a final concentration of 0.23% available iodine. They will be instructed to rinse each nostril with 120ml (total 240mL) in a NeilMedTM sinus rinse bottle, and gargle with 60 mL of the solution. Receives: Drug: Povidone-iodine |
| Placebo sinus rinses and throat gargles | Placebo comparator | Participants will dilute 7 mL of PVP-I placebo into 300 mL of saline. They will be instructed to rinse each nostril with 120ml (total 240mL) in a NeilMedTM sinus rinse bottle, and gargle with 60 mL of the solution. Receives: Drug: Placebo |
| PVP-I gel forming nasal spray | Experimental | 0.6% PVP-I gel forming nasal spray will come prepared and ready for participants to use. They will be instructed to use two sprays to each nostril each time they administer the spray. Receives: Drug: Povidone-iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SARS-CoV-2 positivity in the saliva
A saliva sample will be analyzed to monitor the duration of positivity and when test becomes negative for SARS-CoV-2.
Measured: A saliva sample will be taken every 2 days for 2 weeks, and again at 4 and 6 weeks
Change in the SAR-CoV-2 viral load in the saliva
Quantify the amount of SAR-CoV-2 viral load present in the saliva.
Measured: A saliva sample will be taken every 2 days for 2 weeks, and again at 4 and 6 weeks
Secondary outcomes (3)
Change in Wisconsin Upper Respiratory Symptom Survey (WURSS-44)
This is a 44 question, quality of life survey designed to measure different aspects affected by the common cold.
Measured: daily for 2 weeks, 4 weeks, and 6 weeks
Change Sino nasal Outcome Test (SNOT-22)
That includes 22 questions about symptoms and social/emotional consequences of your nasal disorder.
Measured: baseline, 2 weeks, 4 weeks, 6 weeks
Change in clinical condition
We will record and worsening of clinical condition such as, need for hospitalization/oxygen support.
Measured: daily for 2 weeks, 4 weeks, and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start19 Jan 2021
- Primary completion16 Aug 2021
- Study completion16 Aug 2021
Why it stopped: The site struggled with patient recruitment as we were not able to reach patients with COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Paul's Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Javer, St. Paul's Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449965
- Sponsor's protocol ID
- Betadine COVID-19
- Status last verified
- Jul 2022
- First submitted
- 24 Jun 2020
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Topical Povidone-Iodine Rinses in the Management of the Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04449965
- Acronym / sponsor ID
- Betadine COVID-19
- Conditions
- Covid19
- Keywords
- Povidone - Iodine, Covid19, Self-Isolation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The site struggled with patient recruitment as we were not able to reach patients with COVID-19
- Enrolment
- 5 participants (actual)
- Lead sponsor
- St. Paul's Hospital, CanadaUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 29 Jun 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 aim of this study is to determine if Povidone iodine (PVP-I) rinses and throat gargles or a PVP-I gel forming nasal spray compared to a placebo (a treatment that has no physical effect to a person) is an effective treatment for patients diagnosed with COVID-19. These patients have been diagnosed with mild/moderate COVID-19 symptoms and sent home for self-isolation. Patients will be instructed to take either of the two treatments or placebo twice daily for two weeks and have follow up visits 2 and 4 weeks after. The participants will also complete study related procedures such as saliva sample collection, and two questionnaires throughout the study period. The investigators hypothesize that COVID 19 positive participants who use either of the Povidone - Iodine treatment will have a reduction in their viral load, develop a negative oral mucosa sample and improve their clinical symptoms.
Detailed description
The proposed study is a prospective randomized double blinded placebo-controlled study of 6-weeks in duration. Patients who have tested positive and diagnosed with COVID-19 within the previous 72 h and who meet the inclusion and exclusion criteria, will be invited to participate in this study.
This study will be involving non-hospitalized patients who are recovering at home. One arm will use betadine sinonasal rinses and a betadine mouth gargle while another arm will act as a control receiving a placebo (a food coloring agent). A third arm will use a 0.6% PVP-I gel forming nasal spray twice daily. A baseline saliva sample will be collected to assure a positive COVID-19 test and to quantify viral load. Repeat saliva samples will be collected every 2 days for 2 weeks, then at 4 weeks and 6 weeks to quantify test status and quantify viral load reduction. WURSS-44 questionnaires will be completed daily for 2 weeks and then again at 4 weeks and 6 weeks. SNOT-22 questionnaires will be completed at baseline and then again at 2 weeks, 4 weeks, and 6 weeks. The investigators will also monitor for worsening of symptoms and the need for hospitalization for the entire 6 week duration of the study.
Upon enrolment in the study after obtaining positive results for COVID-19, demographic data and clinical data will be obtained by the investigators. Patients will be randomly assigned to one of the study arms delineated above by permuted block randomization
The clinical samples that detect COVID-19 are obtained by collecting a saliva sample prior to rinsing. This will avoid confounding by artificially lowering the viral particles sampled and will minimize any potentially inhibitory effects of the intervention compounds on lab detection. The sample will be put into a sterile collection container and stored in the fridge until it is transported to the laboratory for analysis.
Sample Size
Considering the quick turnover and the rapid doubling time in the number of positive cases and the unprecedented nature of this study's design and treatment, the investigators hope to recruit 20 patients in each study arm as a pilot study around this subject matter. To account for a drop-out rate of 25% the investigators plan to recruit 27 patients in each arm.
Analysis
Primary outcomes
- Time to a negative/undetectable RT-PCR SARS-CoV-2 saliva sample amongst patients rinsing and gargling with 0.23% PVP-I compared to a placebo group measured during the study treatment daily for 2 weeks and at the 4-week and 6-week mark. 1.1. A Kaplan-Meier curve and log rank test will be used to compare the time to a negative saliva test from the start of the study between patients receiving PVP-I to those receiving the placebo. A hazard ratio of >1 will favor treatment with PVP-I, calculated with a 95% confidence interval by Cox proportional hazards model. 1.2. The median time to negative swab in the PVP-I group versus the control will be statistically compared using the unpaired Mann-Whitney U test. 1.3. The proportion of patients with a negative sample will be compared between the PVP-I group and control group at all times points using the Chi-squared test. 1.4. A subsequent risk factor analysis will be conducted using the cox proportional hazards model, investigating the independent influence of various host and disease factors on the time to a negative sample during the study period. The following relevant factors included in the multivariable regression were identified a priori upon consultation with experienced clinicians at our center: gender, age, smoking status (yes/no), baseline viral load, known baseline lung comorbidity (yes/no) , duration of symptoms before treatment.
- SARS-CoV-2 viral load changes in the saliva amongst patients rinsing and gargling with 0.23% PVP-I compared to a placebo group measured during the study treatment daily for 2 weeks and at the 4-week and 6-week mark. 2.1. Logarithmic viral load levels in the saliva samples will be graphed and compared between the PVP-I and placebo group at all time points using the unpaired Mann-Whitney U test. For complete statistical analysis, a value of 1 log base 10 copies/mL will be assigned to samples with undetectable viral levels.
- Time to a negative/undetectable SARS-CoV-2 saliva sample as well as SARS-CoV-2 viral load changes amongst patients rinsing and gargling with 0.23% PVP-I compared to the 0.6% PVP-I gel forming nasal spray for 2 weeks and at the 4-week and 6-week mark.
3.1. Similar analysis as per 1.1, 1.2, 1.3 and 2.1 above in primary outcomes.
Secondary outcomes
- Change in symptom scores between the PVP-I group and placebo group as assessed by the SNOT-22 scores collected at baseline and at the 2-week, 4-week and 6-week mark. 1.1. SNOT-22 scores will be graphed and compared between baseline and each time point for each group separately using the ANOVA with repeated measures test and Bonferroni post hoc test. 1.2. The change in SNOT-22 scores between baseline and each time point will be compared between groups using the unpaired Mann-Whitney U test.
- Change in symptom scores between the PVP-I group and placebo group as assessed by the WURSS-44 scores collected daily from baseline for 2 weeks and at the 4-week and 6-week mark. 2.1. WURSS-44 scores will be graphed and compared between baseline, the 2 week, 4-week and 6-week marks for each group separately using the ANOVA with repeated measures test and Bonferroni post hoc test. 2.2. WURSS-44 scores will be graphed and compared between baseline and at all time points using the unpaired Mann-Whitney U test.
- The need for hospitalization between the PVP-I group and placebo group. 3.1. The Kaplan-Meier technique will also be used to compare the need for hospitalization from the start of the study between both groups.
- The change in SNOT-22 scores, WURSS-44 scores and the need for hospitalization between patients rinsing and gargling with 0.23% PVP-I compared to the 0.6% PVP-I gel forming nasal spray.
4.1. Similar analysis as per 1.1, 1.2, 2.1, 2.2 and 3.1 above in secondary outcomes.
Descriptive statistics (mean, median, SD) will be used to describe demographic characteristics of the patients. Results will be considered statistically significant with p values < 0.05. All statistical analyzes will be performed using RStudio version 3.4.1 (RStudio, Boston, MA, USA).
Assessment of Safety
Safety Monitoring
Patients who experience signs and symptoms of iodine reaction will be noted and the code will be broken so that a discussion can occur between the research supervisor and the patient regarding the use of the topical iodine.
Patients can contact the office anytime if they notice any of the signs or symptoms of iodine reaction and will be seen by the research supervisor (or designate) within 24 hours.
Adverse Events (AE's)
All expected and unexpected adverse events will be recorded and graded by the research supervisor. Stable chronic conditions, which are present prior to the clinical trial entry and do not worsen, are not considered adverse events and will be accounted for in the patient's medical history.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PVP-I sinus rinses and throat gargles | Experimental | Drug: Povidone-iodineParticipants will dilute 7 mL of 10% PVP-I into 300 mL of saline for a final concentration of 0.23% available iodine. They will be instructed to rinse each nostril with 120ml (total 240mL) in a NeilMedTM sinus rinse bottle, and gargle with 60 mL of the solution. |
| Placebo sinus rinses and throat gargles | Placebo comparator | Drug: PlaceboParticipants will dilute 7 mL of PVP-I placebo into 300 mL of saline. They will be instructed to rinse each nostril with 120ml (total 240mL) in a NeilMedTM sinus rinse bottle, and gargle with 60 mL of the solution. |
| PVP-I gel forming nasal spray | Experimental | Drug: Povidone-iodine0.6% PVP-I gel forming nasal spray will come prepared and ready for participants to use. They will be instructed to use two sprays to each nostril each time they administer the spray. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 years or older
- Patients diagnosed with laboratory-confirmed SARS-CoV-2 and the development of COVID-19 compatible symptoms within the last 72 hours before enrolment
- Do not require hospitalization
Key exclusion criteria (7 listed)
- Sinonasal tumor
- Hypersensitivity to iodine or betadine
- History of thyroid disorder including thyroid cancer, hyperthyroidism and hypothyroidism
- Use of medications for thyroid disorders including thyroxine and carbimazole
- Current use of topical iodine or betadine for another reason
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-iodineAlso: BetadineThis will be performed twice daily for two weeks. | Drug | PVP-I gel forming nasal spray, PVP-I sinus rinses and throat gargles |
| PlaceboThis will be performed twice daily for two weeks. | Drug | Placebo sinus rinses and throat gargles |
Primary outcome
Change in SARS-CoV-2 positivity in the saliva
Time frame: A saliva sample will be taken every 2 days for 2 weeks, and again at 4 and 6 weeks
A saliva sample will be analyzed to monitor the duration of positivity and when test becomes negative for SARS-CoV-2.
Change in the SAR-CoV-2 viral load in the saliva
Time frame: A saliva sample will be taken every 2 days for 2 weeks, and again at 4 and 6 weeks
Quantify the amount of SAR-CoV-2 viral load present in the saliva.
3 secondary outcomes
Change in Wisconsin Upper Respiratory Symptom Survey (WURSS-44)
Time frame: daily for 2 weeks, 4 weeks, and 6 weeks
Change Sino nasal Outcome Test (SNOT-22)
Time frame: baseline, 2 weeks, 4 weeks, 6 weeks
Change in clinical condition
Time frame: daily for 2 weeks, 4 weeks, and 6 weeks
Results and safety
The study was stopped early (reason given: The site struggled with patient recruitment as we were not able to reach patients with COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
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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 Povidone-iodine in people with Covid19, run by St. Paul's Hospital, Canada at 1 site in Canada.
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 7 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: stopped early, as of the sponsor's last update on 11 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 Canada. 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?
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 was stopped early (reason given: The site struggled with patient recruitment as we were not able to reach patients with COVID-19). Results are not available in the source record.
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 in SARS-CoV-2 positivity in the saliva (time frame: A saliva sample will be taken every 2 days for 2 weeks, and again at 4 and 6 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 11 Jul 2022.