A Phase 1/2 interventional study of Povidone-Iodine 2% and Povidone-Iodine 0.5% in COVID-19, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-21.
Sponsored by Stanford University · Phase 1/2, Interventional, and Treatment
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."
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 47 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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Exclusion Criteria:
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.
Drug: Povidone-Iodine 2%
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
Drug: Povidone-Iodine 0.5%
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.
Drug: Isotonic saline 0.9%
Two sprays to each nare of PVP-I 2% via nasal spray bottle, four times a day
Two sprays to each nare of PVP-I 0.5% via nasal spray bottle, four times a day
Two sprays to each nare of isotonic saline (0.9% NaCl) via nasal spray bottle, four times a day
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.
Time frame: Day 1 (baseline), Day 1 (1 hour), Day 3
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.
Time frame: Assessed on days 3 and 5
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.'
Time frame: 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.'
Time frame: 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.'
Time frame: 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.'
Time frame: 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.'
Time frame: 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.'
Time frame: 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.'
Time frame: 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.
Time frame: 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).
Time frame: Day 1 (baseline), Day 30
| Milestone | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% |
|---|---|---|---|
| Started | 15 | 15 | 17 |
| Received allocated intervention | 12 | 15 | 14 |
| Negative pcr swab at baseline | 1 | 3 | 1 |
| Completed | 12 | 14 | 14 |
| Not completed | 3 | 1 | 3 |
| Withdrew: Did not present to study site for allocated intervention | 3 | 0 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
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.
| cycles | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% |
|---|---|---|---|
| Baseline | 24.36 ± 6.83 | 26.03 ± 4.86 | 28.42 ± 6.42 |
| Hour 1 | 25.71 ± 6.87 | 26.46 ± 5.36 | 27.45 ± 8.09 |
| Day 3 | 29.20 ± 6.82 | 36.26 ± 21.56 | 31.01 ± 7.12 |
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 | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% |
|---|---|---|---|
| Nasal burning or pain - Day 3 | 4 | 2 | 13 |
| Nasal burning or pain - Day 5 | 2 | 2 | 13 |
| Headaches - Day 3 | 3 | 3 | 5 |
| Headaches - Day 5 | 2 | 2 | 6 |
| Ear pain - Day 3 | 1 | 0 | 2 |
| Ear pain - Day 5 | 1 | 0 | 2 |
| Sneezing - Day 3 | 4 | 1 | 9 |
| Sneezing - Day 5 | 4 | 1 | 9 |
| Nose bleeds - Day 3 | 1 | 0 | 1 |
| Nose bleeds - Day 5 | 1 | 0 | 1 |
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 | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% |
|---|---|---|---|
| Day 3 - Mild | 0 | 0 | 0 |
| Day 3 - Moderate | 1 | 0 | 0 |
| Day 3 - Severe | 0 | 0 | 0 |
| Day 5 - Mild | 0 | 0 | 0 |
| Day 5 - Moderate | 0 | 0 | 0 |
| Day 5 - Severe | 1 | 0 | 0 |
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 | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% |
|---|---|---|---|
| Day 3 - Mild | 1 | 0 | 1 |
| Day 3 - Moderate | 2 | 0 | 0 |
| Day 3 - Severe | 0 | 0 | 0 |
| Day 5 - Mild | 2 | 0 | 0 |
| Day 5 - Moderate | 1 | 0 | 0 |
| Day 5 - Severe | 1 | 0 | 0 |
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 | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% |
|---|---|---|---|
| Day 3 - Mild | 4 | 5 | 6 |
| Day 3 - Moderate | 1 | 2 | 0 |
| Day 3 - Severe | 1 | 0 | 0 |
| Day 5 - Mild | 3 | 3 | 2 |
| Day 5 - Moderate | 2 | 3 | 0 |
| Day 5 - Severe | 0 | 0 | 0 |
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 | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% |
|---|---|---|---|
| Day 3 - Mild | 2 | 3 | 2 |
| Day 3 - Moderate | 0 | 2 | 1 |
| Day 3 - Severe | 2 | 1 | 4 |
| Day 5 - Mild | 2 | 2 | 3 |
| Day 5 - Moderate | 1 | 2 | 2 |
| Day 5 - Severe | 1 | 1 | 1 |
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 | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% |
|---|---|---|---|
| Day 3 - Mild | 3 | 4 | 3 |
| Day 3 - Moderate | 0 | 1 | 0 |
| Day 3 - Severe | 1 | 1 | 3 |
| Day 5 - Mild | 0 | 1 | 2 |
| Day 5 - Moderate | 1 | 2 | 1 |
| Day 5 - Severe | 0 | 1 | 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 | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% |
|---|---|---|---|
| Day 3 - Mild | 5 | 5 | 7 |
| Day 3 - Moderate | 3 | 2 | 4 |
| Day 3 - Severe | 0 | 0 | 0 |
| Day 5 - Mild | 5 | 4 | 6 |
| Day 5 - Moderate | 2 | 1 | 0 |
| Day 5 - Severe | 0 | 0 | 0 |
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 | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% |
|---|---|---|---|
| Day 3 - Mild | 4 | 0 | 4 |
| Day 3 - Moderate | 0 | 0 | 0 |
| Day 3 - Severe | 0 | 0 | 0 |
| Day 5 - Mild | 1 | 0 | 2 |
| Day 5 - Moderate | 0 | 0 | 0 |
| Day 5 - Severe | 0 | 0 | 0 |
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 | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% |
|---|---|---|---|
| 76-100% compliant | 11 | 11 | 13 |
| 51-75% compliant | 0 | 0 | 0 |
| 26-50% compliant | 0 | 0 | 0 |
| 0-25% compliant | 0 | 0 | 0 |
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 | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% |
|---|---|---|---|
| Anosmia - Baseline | 2 | 4 | 5 |
| Anosmia - day 30 | 0 | 0 | 0 |
| Severe microsmia - baseline | 3 | 1 | 1 |
| Severe microsmia - day 30 | 2 | 1 | 1 |
| Moderate microsmia - baseline | 2 | 2 | 2 |
| Moderate microsmia - day 30 | 0 | 0 | 1 |
| Mild microsmia - baseline | 2 | 0 | 3 |
| Mild microsmia - day 30 | 5 | 2 | 3 |
| Normosmia - baseline | 2 | 3 | 1 |
| Normosmia - day 30 | 3 | 8 | 7 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Isotonic Saline 0.9% | 0/15 (0%) | 0/15 (0%) | 6/15 (40%) |
| Povidone-Iodine 0.5% | 0/15 (0%) | 0/15 (0%) | 6/15 (40%) |
| Povidone-Iodine 2% | 0/17 (0%) | 0/17 (0%) | 13/17 (76.5%) |
| Event | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% |
|---|---|---|---|
| Nasal burningRespiratory, thoracic and mediastinal disorders | 1/15 | 4/15 | 13/17 |
| SneezingRespiratory, thoracic and mediastinal disorders | 1/15 | 5/15 | 11/17 |
| HeadachesNervous system disorders | 4/15 | 3/15 | 7/17 |
| Ear painEar and labyrinth disorders | 0/15 | 1/15 | 3/17 |
| NosebleedsRespiratory, thoracic and mediastinal disorders | 0/15 | 1/15 | 2/17 |
Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
| Age, Continuous(years) | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% | Total |
|---|---|---|---|---|
| Mean | 44.2 ± 15.6 | 45.2 ± 12.2 | 40.7 ± 19.9 | 43.2 ± 18.0 |
| Sex: Female, Male(Participants) | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% | Total |
|---|---|---|---|---|
| Female | 8 | 5 | 5 | 18 |
| Male | 3 | 6 | 8 | 17 |
| Race/Ethnicity, Customized(Participants) | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% | Total |
|---|---|---|---|---|
| White | 8 | 7 | 10 | 25 |
| Hispanic | 1 | 3 | 3 | 7 |
| Asian | 2 | 1 | 0 | 3 |
| Region of Enrollment(Participants) | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% | Total |
|---|---|---|---|---|
| United States | 11 | 11 | 13 | 35 |
| Days since positive COVID test to enrollment(days) | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% | Total |
|---|---|---|---|---|
| Mean | 3.9 ± 2.8 | 3.7 ± 1.5 | 3.0 ± 1.1 | 3.5 ± 1.9 |
| Days since symptoms to enrollment(days) | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% | Total |
|---|---|---|---|---|
| Mean | 4.8 ± 2.2 | 7.2 ± 2.6 | 7.1 ± 3.2 | 6.3 ± 2.8 |
| Active tobacco use(Participants) | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% | Total |
|---|---|---|---|---|
| Count of participants | 0 | 0 | 0 | 0 |
| Comorbidities(Participants) | Isotonic Saline 0.9% | Povidone-Iodine 0.5% | Povidone-Iodine 2% | Total |
|---|---|---|---|---|
| Sinusitis/allergy | 2 | 1 | 0 | 3 |
| Respiratory disease/Asthma | 2 | 0 | 0 | 2 |
| Cardiac disease | 0 | 1 | 1 | 2 |
| Neurodegenerative disease | 0 | 0 | 0 | 0 |
3 further baseline measures are reported on the registry.
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