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The study aims to determine the safety and efficacy of povidone-iodine (PVP-I) containing nasal sprays as compared to isotonic saline nasal sprays in COVID-19 positive patients. The primary outcome measure is SARS-CoV-2 viral titers in the nasal cavity and nasopharynx. In vitro studies have shown PVP-I to be highly virucidal against the viruses which cause SARS and MERS. Additionally, clinical studies have shown PVP-I saline sprays to be well tolerated in human subjects. PVP-I oral rinses and sprays have been trialed as methods to reduce the incidence and symptoms of viruses which cause the "common cold."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Povidone-Iodine 2% | Experimental | Participants will administer PVP-I 2% nasal spray for 5 days. Nasopharyngeal swabs will be taken on Day 1 at baseline, Day 1 at four hours post-first dose, and Day 5. Participants will complete a daily symptom journal from Day 1 through Day 5. |
|
| Povidone-Iodine 0.5% | Experimental | Participants will administer PVP-I 0.5% nasal spray for 5 days. Nasopharyngeal swabs will be taken on Day 1 at baseline, Day 1 at four hours post-first dose, and Day 5. Participants will complete a daily symptom journal from Day 1 through Day 5 |
|
| Isotonic saline 0.9% | Placebo Comparator | Participants will administer two sprays of isotonic saline nasal spray for 5 days. Nasopharyngeal swabs will be taken on Day 1 at baseline, Day 1 at four hours post-first dose, and Day 5. Participants will complete a daily symptom journal from Day 1 through Day 5. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-Iodine 2% | Drug | Two sprays to each nare of PVP-I 2% via nasal spray bottle, four times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2 | Nasopharyngeal swabs were obtained and quantitative reverse transcription-polymerase chain reaction (RT-PCR) testing was performed to determine the viral load in the nasopharynx. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to ~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2. | Day 1 (baseline), Day 1 (1 hour), Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Participants were asked on day 3 whether they experienced the adverse event since baseline, then asked on day 5 whether they experienced the adverse event since day 3 (collected by questionnaire). Adverse events of interest include: Nasal burning/pain, headaches, ear pain, sneezing, and nose bleeds. | Assessed on days 3 and 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayakar V. Nayak, MD, PhD | Stanford University | Principal Investigator |
| Neelaysh Vukkadala, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Health Care | Stanford | California | 94305 | United States |
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265 patients were assessed for eligibility; 47 patients were randomized into the study,
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| ID | Title | Description |
|---|---|---|
| FG000 | Isotonic Saline 0.9% | Participants administer 2 sprays of isotonic saline (0.9% NaCl) to each nare via nasal spray bottle, four times a day for 5 days. |
| FG001 | Povidone-Iodine 0.5% | Participants administer 2 sprays of povidone-iodine (PVP-I) 0.5% to each nare via nasal spray bottle, four times a day for 5 days. |
| FG002 | Povidone-Iodine 2% | Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | Isotonic Saline 0.9% | Participants administer 2 sprays of isotonic saline (0.9% NaCl) to each nare via nasal spray bottle, four times a day for 5 days. |
| BG001 | Povidone-Iodine 0.5% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2 | Nasopharyngeal swabs were obtained and quantitative reverse transcription-polymerase chain reaction (RT-PCR) testing was performed to determine the viral load in the nasopharynx. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to ~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2. | Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded. | Posted | Mean | Standard Deviation | cycles | Day 1 (baseline), Day 1 (1 hour), Day 3 |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Isotonic Saline 0.9% | Participants administer 2 sprays of isotonic saline (0.9% NaCl) to each nare via nasal spray bottle, four times a day for 5 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal burning | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
The study did not meet its accrual goal of 45 participants with analyzable data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jayakar Nayak, MD, PhD | Stanford University | (650) 723-5281 | jnayak@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2020 | Jul 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Povidone-Iodine 0.5% | Drug | Two sprays to each nare of PVP-I 0.5% via nasal spray bottle, four times a day |
|
| Isotonic saline 0.9% | Drug | Two sprays to each nare of isotonic saline (0.9% NaCl) via nasal spray bottle, four times a day |
|
| Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Count of participants that experienced fevers at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.' | Assessed on days 3 and 5 |
| Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Count of participants that experienced chills at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.' | Assessed on days 3 and 5 |
| Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Count of participants that experienced fatigue at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.' | Assessed on days 3 and 5 |
| Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Count of participants that experienced loss of sense of smell at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.' | Assessed on days 3 and 5 |
| Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Count of participants that experienced loss of sense of taste at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.' | Assessed on days 3 and 5 |
| Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Count of participants that experienced nasal congestion at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.' | Assessed on days 3 and 5 |
| Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Count of participants that experienced sore throat at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.' | Assessed on days 3 and 5 |
| Compliance With Study Drug Administration | Participants were asked to estimated doses completed at day 5 (0-25%, 26-50%, 51-75%, or 76-100%). The count of participants who estimated their compliance to be within each range is reported. | 5 days |
| Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT) | Participants scratch test cards and attempt to identify the smell from a multiple choice set of options. Their scores are then computed and categorized as normosmia (normal), mild, moderate, or severe microsmia (loss of smell), or anosmia (total loss of smell). | Day 1 (baseline), Day 30 |
Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
| BG002 | Povidone-Iodine 2% | Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Days since positive COVID test to enrollment | Mean | Standard Deviation | days |
|
| Days since symptoms to enrollment | Mean | Standard Deviation | days |
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| Active tobacco use | Count of Participants | Participants |
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| Comorbidities | Count of Participants | Participants |
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| Prior Treatment | Count of Participants | Participants |
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| Noted change to taste or smell at enrollment | Count of Participants | Participants |
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| Risk factors for smell loss | Count of Participants | Participants |
|
Participants administer 2 sprays of isotonic saline (0.9% NaCl) to each nare via nasal spray bottle, four times a day for 5 days. |
| OG001 | Povidone-Iodine 0.5% | Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days. |
| OG002 | Povidone-Iodine 2% | Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days. |
|
|
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| Secondary | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Participants were asked on day 3 whether they experienced the adverse event since baseline, then asked on day 5 whether they experienced the adverse event since day 3 (collected by questionnaire). Adverse events of interest include: Nasal burning/pain, headaches, ear pain, sneezing, and nose bleeds. | Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded. | Posted | Count of Participants | Participants | Assessed on days 3 and 5 |
|
|
|
| Secondary | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Count of participants that experienced fevers at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.' | Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded. | Posted | Count of Participants | Participants | Assessed on days 3 and 5 |
|
|
|
| Secondary | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Count of participants that experienced chills at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.' | Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded. | Posted | Count of Participants | Participants | Assessed on days 3 and 5 |
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| Secondary | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Count of participants that experienced fatigue at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.' | Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded. | Posted | Count of Participants | Participants | Assessed on days 3 and 5 |
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| Secondary | Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Count of participants that experienced loss of sense of smell at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.' | Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded. | Posted | Count of Participants | Participants | Assessed on days 3 and 5 |
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| Secondary | Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Count of participants that experienced loss of sense of taste at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.' | Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded. | Posted | Count of Participants | Participants | Assessed on days 3 and 5 |
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| Secondary | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Count of participants that experienced nasal congestion at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.' | Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded. | Posted | Count of Participants | Participants | Assessed on days 3 and 5 |
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| Secondary | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Count of participants that experienced sore throat at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.' | Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded. | Posted | Count of Participants | Participants | Assessed on days 3 and 5 |
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| Secondary | Compliance With Study Drug Administration | Participants were asked to estimated doses completed at day 5 (0-25%, 26-50%, 51-75%, or 76-100%). The count of participants who estimated their compliance to be within each range is reported. | Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded. | Posted | Count of Participants | Participants | 5 days |
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| Secondary | Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT) | Participants scratch test cards and attempt to identify the smell from a multiple choice set of options. Their scores are then computed and categorized as normosmia (normal), mild, moderate, or severe microsmia (loss of smell), or anosmia (total loss of smell). | Participants who received the allocated intervention and completed the study and with data available for the respective time point; participants with negative PCR nasal swab results at baseline or incomplete data were excluded. | Posted | Count of Participants | Participants | Day 1 (baseline), Day 30 |
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| 0 |
| 15 |
| 0 |
| 15 |
| 6 |
| 15 |
| EG001 | Povidone-Iodine 0.5% | Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days. | 0 | 15 | 0 | 15 | 6 | 15 |
| EG002 | Povidone-Iodine 2% | Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days. | 0 | 17 | 0 | 17 | 13 | 17 |
| Headaches | Nervous system disorders | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nosebleeds | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Headaches - Day 3 |
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| Headaches - Day 5 |
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| Ear pain - Day 3 |
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| Ear pain - Day 5 |
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| Sneezing - Day 3 |
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| Sneezing - Day 5 |
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| Nose bleeds - Day 3 |
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| Nose bleeds - Day 5 |
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| Title | Measurements |
|---|---|
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| Day 3 - Severe |
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| Day 5 - Mild |
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| Day 5 - Moderate |
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| Day 5 - Severe |
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| Title | Measurements |
|---|---|
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| Day 3 - Severe |
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| Day 5 - Mild |
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| Day 5 - Moderate |
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| Day 5 - Severe |
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| Title | Measurements |
|---|---|
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| Day 3 - Severe |
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| Day 5 - Mild |
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| Day 5 - Moderate |
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| Day 5 - Severe |
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| Title | Measurements |
|---|---|
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| Day 3 - Severe |
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| Day 5 - Mild |
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| Day 5 - Moderate |
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| Day 5 - Severe |
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| Title | Measurements |
|---|---|
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| Day 3 - Severe |
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| Day 5 - Mild |
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| Day 5 - Moderate |
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| Day 5 - Severe |
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| Title | Measurements |
|---|---|
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| Day 3 - Severe |
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| Day 5 - Mild |
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| Day 5 - Moderate |
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| Day 5 - Severe |
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| Title | Measurements |
|---|---|
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| Day 3 - Severe |
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| Day 5 - Mild |
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| Day 5 - Moderate |
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| Day 5 - Severe |
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| 26-50% compliant |
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| 0-25% compliant |
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| Anosmia - day 30 |
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| Severe microsmia - baseline |
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| Severe microsmia - day 30 |
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| Moderate microsmia - baseline |
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| Moderate microsmia - day 30 |
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| Mild microsmia - baseline |
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| Mild microsmia - day 30 |
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| Normosmia - baseline |
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| Normosmia - day 30 |
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