COVID-19
Conditions
Keywords
nasal spray, PVP-I, COVID-19
Brief summary
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.
Interventions
DRUGPovidone-Iodine 2%
Two sprays to each nare of PVP-I 2% via nasal spray bottle, four times a day
DRUGPovidone-Iodine 0.5%
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
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of COVID-19 by lab test within 5 days of study participation
Exclusion criteria
* Allergy to iodine, shellfish, or food dye * Receiving intranasal steroids * Sinus surgery within 30 days of beginning the study * Intubated at the time of enrollment * Pregnancy * Participation in other COVID-19 studies - to be determined on a case by case basis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2 | Day 1 (baseline), Day 1 (1 hour), Day 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Assessed on days 3 and 5 | 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.' |
| Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Assessed on days 3 and 5 | 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.' |
| Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Assessed on days 3 and 5 | 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.' |
| Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Assessed on days 3 and 5 | 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.' |
| Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Assessed on days 3 and 5 | 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. |
| Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Assessed on days 3 and 5 | 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.' |
| Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Assessed on days 3 and 5 | 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.' |
| Compliance With Study Drug Administration | 5 days | 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. |
| Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT) | Day 1 (baseline), Day 30 | 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). |
| Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Assessed on days 3 and 5 | 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.' |
Countries
United States
Participant flow
Pre-assignment details
265 patients were assessed for eligibility; 47 patients were randomized into the study,
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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. | 11 |
| 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. | 13 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 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
| Characteristic | Povidone-Iodine 0.5% | Povidone-Iodine 2% | Total | Isotonic Saline 0.9% |
|---|---|---|---|---|
| Active tobacco use | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 45.2 years STANDARD_DEVIATION 12.2 | 40.7 years STANDARD_DEVIATION 19.9 | 43.2 years STANDARD_DEVIATION 18 | 44.2 years STANDARD_DEVIATION 15.6 |
| Comorbidities Cardiac disease | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| Comorbidities Neurodegenerative disease | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Comorbidities Respiratory disease/Asthma | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Comorbidities Sinusitis/allergy | 1 Participants | 0 Participants | 3 Participants | 2 Participants |
| Days since positive COVID test to enrollment | 3.7 days STANDARD_DEVIATION 1.5 | 3.0 days STANDARD_DEVIATION 1.1 | 3.5 days STANDARD_DEVIATION 1.9 | 3.9 days STANDARD_DEVIATION 2.8 |
| Days since symptoms to enrollment | 7.2 days STANDARD_DEVIATION 2.6 | 7.1 days STANDARD_DEVIATION 3.2 | 6.3 days STANDARD_DEVIATION 2.8 | 4.8 days STANDARD_DEVIATION 2.2 |
| Noted change to taste or smell at enrollment | 6 Participants | 8 Participants | 19 Participants | 5 Participants |
| Prior Treatment None | 10 Participants | 12 Participants | 33 Participants | 11 Participants |
| Prior Treatment Saline nasal irrigations | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Prior Treatment Tylenol/NSAIDs | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants | 3 Participants | 7 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 7 Participants | 10 Participants | 25 Participants | 8 Participants |
| Region of Enrollment United States | 11 Participants | 13 Participants | 35 Participants | 11 Participants |
| Risk factors for smell loss History of head trauma | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Risk factors for smell loss History of sinus surgery | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 18 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 17 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 17 |
| other Total, other adverse events | 6 / 15 | 6 / 15 | 13 / 17 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 17 |
Outcome results
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.
Time frame: Day 1 (baseline), Day 1 (1 hour), Day 3
Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Povidone-Iodine 0.5% | Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2 | Day 3 | 36.26 cycles | Standard Deviation 21.56 |
| Povidone-Iodine 0.5% | Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2 | Hour 1 | 26.46 cycles | Standard Deviation 5.36 |
| Povidone-Iodine 0.5% | Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2 | Baseline | 26.03 cycles | Standard Deviation 4.86 |
| Povidone-Iodine 2% | Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2 | Baseline | 28.42 cycles | Standard Deviation 6.42 |
| Povidone-Iodine 2% | Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2 | Hour 1 | 27.45 cycles | Standard Deviation 8.09 |
| Povidone-Iodine 2% | Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2 | Day 3 | 31.01 cycles | Standard Deviation 7.12 |
Comparison: Analysis of change in mean Ct values incorporating baseline, hour 1, and day 3 values.95% CI: [-1.584, 0.886]
Comparison: Analysis of change in mean Ct values incorporating baseline, hour 1, and day 3 values.95% CI: [-2.318, 0.201]
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.
Time frame: 5 days
Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Isotonic Saline 0.9% | Compliance With Study Drug Administration | 76-100% compliant | 11 Participants |
| Isotonic Saline 0.9% | Compliance With Study Drug Administration | 51-75% compliant | 0 Participants |
| Isotonic Saline 0.9% | Compliance With Study Drug Administration | 26-50% compliant | 0 Participants |
| Isotonic Saline 0.9% | Compliance With Study Drug Administration | 0-25% compliant | 0 Participants |
| Povidone-Iodine 0.5% | Compliance With Study Drug Administration | 0-25% compliant | 0 Participants |
| Povidone-Iodine 0.5% | Compliance With Study Drug Administration | 76-100% compliant | 11 Participants |
| Povidone-Iodine 0.5% | Compliance With Study Drug Administration | 26-50% compliant | 0 Participants |
| Povidone-Iodine 0.5% | Compliance With Study Drug Administration | 51-75% compliant | 0 Participants |
| Povidone-Iodine 2% | Compliance With Study Drug Administration | 0-25% compliant | 0 Participants |
| Povidone-Iodine 2% | Compliance With Study Drug Administration | 51-75% compliant | 0 Participants |
| Povidone-Iodine 2% | Compliance With Study Drug Administration | 26-50% compliant | 0 Participants |
| Povidone-Iodine 2% | Compliance With Study Drug Administration | 76-100% compliant | 13 Participants |
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.
Time frame: Assessed on days 3 and 5
Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Isotonic Saline 0.9% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Nasal burning or pain - Day 3 | 4 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Ear pain - Day 3 | 1 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Nasal burning or pain - Day 5 | 2 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Headaches - Day 3 | 3 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Headaches - Day 5 | 2 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Ear pain - Day 5 | 1 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Sneezing - Day 3 | 4 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Sneezing - Day 5 | 4 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Nose bleeds - Day 3 | 1 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Nose bleeds - Day 5 | 1 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Nose bleeds - Day 3 | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Ear pain - Day 5 | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Ear pain - Day 3 | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Nasal burning or pain - Day 3 | 2 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Nose bleeds - Day 5 | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Sneezing - Day 5 | 1 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Nasal burning or pain - Day 5 | 2 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Headaches - Day 5 | 2 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Sneezing - Day 3 | 1 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Headaches - Day 3 | 3 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Sneezing - Day 3 | 9 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Headaches - Day 5 | 6 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Ear pain - Day 3 | 2 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Ear pain - Day 5 | 2 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Nose bleeds - Day 3 | 1 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Headaches - Day 3 | 5 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Nose bleeds - Day 5 | 1 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Nasal burning or pain - Day 3 | 13 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Nasal burning or pain - Day 5 | 13 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays | Sneezing - Day 5 | 9 Participants |
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.'
Time frame: Assessed on days 3 and 5
Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Isotonic Saline 0.9% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 1 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 0 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 1 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 1 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 2 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 2 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 1 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 0 Participants |
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.'
Time frame: Assessed on days 3 and 5
Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Isotonic Saline 0.9% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 3 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 2 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 0 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 1 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 4 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 1 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 3 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 5 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 2 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 3 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 6 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 2 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 0 Participants |
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.'
Time frame: Assessed on days 3 and 5
Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Isotonic Saline 0.9% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 1 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 0 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 0 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 0 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 0 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 1 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 0 Participants |
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.'
Time frame: Assessed on days 3 and 5
Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 2 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 3 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 1 Participants |
| Povidone-Iodine 0.5% | 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 |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 2 Participants |
| Povidone-Iodine 0.5% | 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 |
| Povidone-Iodine 2% | Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 1 Participants |
| Povidone-Iodine 2% | 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 |
| Povidone-Iodine 2% | Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 2 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 4 Participants |
| Povidone-Iodine 2% | 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 |
| Povidone-Iodine 2% | Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 3 Participants |
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.'
Time frame: Assessed on days 3 and 5
Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Povidone-Iodine 0.5% | 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 |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 2 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 4 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 1 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 1 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 1 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 2 Participants |
| Povidone-Iodine 2% | 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 |
| Povidone-Iodine 2% | Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 3 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 2 Participants |
| Povidone-Iodine 2% | 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 |
| Povidone-Iodine 2% | 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 |
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.'
Time frame: Assessed on days 3 and 5
Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Isotonic Saline 0.9% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 5 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 2 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 0 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 5 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 3 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 4 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 5 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 2 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 1 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 7 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 6 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 4 Participants |
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.'
Time frame: Assessed on days 3 and 5
Population: Participants who received the allocated intervention and completed the study; participants with negative PCR nasal swab results at baseline or incomplete data were excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Isotonic Saline 0.9% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 0 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 0 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 1 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 0 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 4 Participants |
| Isotonic Saline 0.9% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 0 Participants |
| Povidone-Iodine 0.5% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Moderate | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Severe | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Moderate | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Severe | 0 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 3 - Mild | 4 Participants |
| Povidone-Iodine 2% | Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 | Day 5 - Mild | 2 Participants |
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).
Time frame: Day 1 (baseline), Day 30
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Isotonic Saline 0.9% | 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 |
| Povidone-Iodine 0.5% | Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT) | Mild microsmia - baseline | 0 Participants |
| Povidone-Iodine 0.5% | 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 | 1 Participants |
| Povidone-Iodine 0.5% | 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 |
| Povidone-Iodine 0.5% | 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 | 2 Participants |
| Povidone-Iodine 0.5% | Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT) | Anosmia - Baseline | 4 Participants |
| Povidone-Iodine 0.5% | Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT) | Normosmia - baseline | 3 Participants |
| Povidone-Iodine 0.5% | Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT) | Severe microsmia - baseline | 1 Participants |
| Povidone-Iodine 0.5% | 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 |
| Povidone-Iodine 0.5% | Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT) | Normosmia - day 30 | 8 Participants |
| Povidone-Iodine 0.5% | 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 |
| Povidone-Iodine 2% | Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT) | Normosmia - day 30 | 7 Participants |
| Povidone-Iodine 2% | 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 | 3 Participants |
| Povidone-Iodine 2% | Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT) | Anosmia - Baseline | 5 Participants |
| Povidone-Iodine 2% | 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 |
| Povidone-Iodine 2% | Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT) | Severe microsmia - baseline | 1 Participants |
| Povidone-Iodine 2% | 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 | 1 Participants |
| Povidone-Iodine 2% | 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 |
| Povidone-Iodine 2% | 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 | 1 Participants |
| Povidone-Iodine 2% | Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT) | Mild microsmia - baseline | 3 Participants |
| Povidone-Iodine 2% | Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT) | Normosmia - baseline | 1 Participants |