Trial Outcomes & Findings for PVP-I Nasal Sprays and SARS-CoV-2 Nasopharyngeal Titers (for COVID-19) (NCT NCT04347954)
NCT ID: NCT04347954
Last Updated: 2021-10-21
Results Overview
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.
COMPLETED
PHASE1/PHASE2
47 participants
Day 1 (baseline), Day 1 (1 hour), Day 3
2021-10-21
Participant Flow
265 patients were assessed for eligibility; 47 patients were randomized into the study,
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
17
|
|
Overall Study
Received Allocated Intervention
|
12
|
15
|
14
|
|
Overall Study
Negative PCR Swab at Baseline
|
1
|
3
|
1
|
|
Overall Study
COMPLETED
|
12
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Did not present to study site for allocated intervention
|
3
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
PVP-I Nasal Sprays and SARS-CoV-2 Nasopharyngeal Titers (for COVID-19)
Baseline characteristics by cohort
| Measure |
Isotonic Saline 0.9%
n=11 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.
|
Povidone-Iodine 0.5%
n=11 Participants
Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
|
Povidone-Iodine 2%
n=13 Participants
Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
40.7 years
STANDARD_DEVIATION 19.9 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 18.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Days since positive COVID test to enrollment
|
3.9 days
STANDARD_DEVIATION 2.8 • n=5 Participants
|
3.7 days
STANDARD_DEVIATION 1.5 • n=7 Participants
|
3.0 days
STANDARD_DEVIATION 1.1 • n=5 Participants
|
3.5 days
STANDARD_DEVIATION 1.9 • n=4 Participants
|
|
Days since symptoms to enrollment
|
4.8 days
STANDARD_DEVIATION 2.2 • n=5 Participants
|
7.2 days
STANDARD_DEVIATION 2.6 • n=7 Participants
|
7.1 days
STANDARD_DEVIATION 3.2 • n=5 Participants
|
6.3 days
STANDARD_DEVIATION 2.8 • n=4 Participants
|
|
Active tobacco use
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Comorbidities
Sinusitis/allergy
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Comorbidities
Respiratory disease/Asthma
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Comorbidities
Cardiac disease
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Comorbidities
Neurodegenerative disease
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Prior Treatment
Saline nasal irrigations
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Prior Treatment
Tylenol/NSAIDs
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Prior Treatment
None
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Noted change to taste or smell at enrollment
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Risk factors for smell loss
History of head trauma
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Risk factors for smell loss
History of sinus surgery
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 (baseline), Day 1 (1 hour), Day 3Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
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.
Outcome measures
| Measure |
Isotonic Saline 0.9%
n=11 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.
|
Povidone-Iodine 0.5%
n=11 Participants
Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
|
Povidone-Iodine 2%
n=13 Participants
Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
|
|---|---|---|---|
|
Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2
Baseline
|
24.36 cycles
Standard Deviation 6.83
|
26.03 cycles
Standard Deviation 4.86
|
28.42 cycles
Standard Deviation 6.42
|
|
Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2
Day 3
|
29.20 cycles
Standard Deviation 6.82
|
36.26 cycles
Standard Deviation 21.56
|
31.01 cycles
Standard Deviation 7.12
|
|
Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2
Hour 1
|
25.71 cycles
Standard Deviation 6.87
|
26.46 cycles
Standard Deviation 5.36
|
27.45 cycles
Standard Deviation 8.09
|
SECONDARY outcome
Timeframe: Assessed on days 3 and 5Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
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.
Outcome measures
| Measure |
Isotonic Saline 0.9%
n=11 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.
|
Povidone-Iodine 0.5%
n=11 Participants
Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
|
Povidone-Iodine 2%
n=13 Participants
Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
|
|---|---|---|---|
|
Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays
Nasal burning or pain - Day 3
|
4 Participants
|
2 Participants
|
13 Participants
|
|
Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays
Ear pain - Day 5
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays
Sneezing - Day 3
|
4 Participants
|
1 Participants
|
9 Participants
|
|
Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays
Sneezing - Day 5
|
4 Participants
|
1 Participants
|
9 Participants
|
|
Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays
Nose bleeds - Day 3
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays
Nose bleeds - Day 5
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays
Nasal burning or pain - Day 5
|
2 Participants
|
2 Participants
|
13 Participants
|
|
Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays
Headaches - Day 3
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays
Headaches - Day 5
|
2 Participants
|
2 Participants
|
6 Participants
|
|
Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays
Ear pain - Day 3
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Assessed on days 3 and 5Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
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.'
Outcome measures
| Measure |
Isotonic Saline 0.9%
n=11 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.
|
Povidone-Iodine 0.5%
n=11 Participants
Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
|
Povidone-Iodine 2%
n=13 Participants
Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
|
|---|---|---|---|
|
Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed on days 3 and 5Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
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.'
Outcome measures
| Measure |
Isotonic Saline 0.9%
n=11 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.
|
Povidone-Iodine 0.5%
n=11 Participants
Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
|
Povidone-Iodine 2%
n=13 Participants
Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
|
|---|---|---|---|
|
Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Mild
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Mild
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Moderate
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed on days 3 and 5Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
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.'
Outcome measures
| Measure |
Isotonic Saline 0.9%
n=11 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.
|
Povidone-Iodine 0.5%
n=11 Participants
Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
|
Povidone-Iodine 2%
n=13 Participants
Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
|
|---|---|---|---|
|
Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Mild
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Mild
|
4 Participants
|
5 Participants
|
6 Participants
|
|
Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Moderate
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Moderate
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed on days 3 and 5Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
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.'
Outcome measures
| Measure |
Isotonic Saline 0.9%
n=11 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.
|
Povidone-Iodine 0.5%
n=11 Participants
Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
|
Povidone-Iodine 2%
n=13 Participants
Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
|
|---|---|---|---|
|
Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Mild
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Moderate
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Severe
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Mild
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Moderate
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Severe
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Assessed on days 3 and 5Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
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.'
Outcome measures
| Measure |
Isotonic Saline 0.9%
n=11 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.
|
Povidone-Iodine 0.5%
n=11 Participants
Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
|
Povidone-Iodine 2%
n=13 Participants
Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
|
|---|---|---|---|
|
Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Mild
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Severe
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Mild
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Moderate
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Severe
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Assessed on days 3 and 5Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
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.'
Outcome measures
| Measure |
Isotonic Saline 0.9%
n=11 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.
|
Povidone-Iodine 0.5%
n=11 Participants
Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
|
Povidone-Iodine 2%
n=13 Participants
Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
|
|---|---|---|---|
|
Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Mild
|
5 Participants
|
5 Participants
|
7 Participants
|
|
Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Moderate
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Mild
|
5 Participants
|
4 Participants
|
6 Participants
|
|
Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Moderate
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed on days 3 and 5Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
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.'
Outcome measures
| Measure |
Isotonic Saline 0.9%
n=11 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.
|
Povidone-Iodine 0.5%
n=11 Participants
Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
|
Povidone-Iodine 2%
n=13 Participants
Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
|
|---|---|---|---|
|
Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Mild
|
4 Participants
|
0 Participants
|
4 Participants
|
|
Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 3 - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Mild
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2
Day 5 - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
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.
Outcome measures
| Measure |
Isotonic Saline 0.9%
n=11 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.
|
Povidone-Iodine 0.5%
n=11 Participants
Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
|
Povidone-Iodine 2%
n=13 Participants
Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
|
|---|---|---|---|
|
Compliance With Study Drug Administration
76-100% compliant
|
11 Participants
|
11 Participants
|
13 Participants
|
|
Compliance With Study Drug Administration
51-75% compliant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Compliance With Study Drug Administration
26-50% compliant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Compliance With Study Drug Administration
0-25% compliant
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (baseline), Day 30Population: 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.
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).
Outcome measures
| Measure |
Isotonic Saline 0.9%
n=11 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.
|
Povidone-Iodine 0.5%
n=11 Participants
Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
|
Povidone-Iodine 2%
n=13 Participants
Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
|
|---|---|---|---|
|
Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT)
Mild microsmia - baseline
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT)
Anosmia - Baseline
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT)
Anosmia - day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT)
Severe microsmia - baseline
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT)
Severe microsmia - day 30
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT)
Moderate microsmia - baseline
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT)
Moderate microsmia - day 30
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT)
Mild microsmia - day 30
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT)
Normosmia - baseline
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT)
Normosmia - day 30
|
3 Participants
|
8 Participants
|
7 Participants
|
Adverse Events
Isotonic Saline 0.9%
Povidone-Iodine 0.5%
Povidone-Iodine 2%
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Isotonic Saline 0.9%
n=15 participants at risk
Participants administer 2 sprays of isotonic saline (0.9% NaCl) to each nare via nasal spray bottle, four times a day for 5 days.
|
Povidone-Iodine 0.5%
n=15 participants at risk
Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.
|
Povidone-Iodine 2%
n=17 participants at risk
Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal burning
|
6.7%
1/15 • 30 days
|
26.7%
4/15 • 30 days
|
76.5%
13/17 • 30 days
|
|
Nervous system disorders
Headaches
|
26.7%
4/15 • 30 days
|
20.0%
3/15 • 30 days
|
41.2%
7/17 • 30 days
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/15 • 30 days
|
6.7%
1/15 • 30 days
|
17.6%
3/17 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.7%
1/15 • 30 days
|
33.3%
5/15 • 30 days
|
64.7%
11/17 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Nosebleeds
|
0.00%
0/15 • 30 days
|
6.7%
1/15 • 30 days
|
11.8%
2/17 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place