NCT04347954 is a Phase 1, PHASE2 clinical trial of Povidone-Iodine 2% in COVID-19, sponsored by Stanford University.

Who is sponsoring NCT04347954?

NCT04347954 is sponsored by Stanford University.

What drugs are being tested in NCT04347954?

Interventions in NCT04347954: Povidone-Iodine 2%, Povidone-Iodine 0.5%, Isotonic saline 0.9%.

Is NCT04347954 still recruiting?

NCT04347954 is currently completed. Last updated 21 October 2021.

Are results published for NCT04347954?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-10-21 · How we verify

NCT04347954

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PVP-I Nasal Sprays and SARS-CoV-2 Nasopharyngeal Titers (for COVID-19)

Completed Phase 1, PHASE2 Results posted Last updated 21 October 2021

What this trial tests

Phase 1, PHASE2 trial testing Povidone-Iodine 2% in COVID-19 in 47 participants. Completed in 13 December 2020.

Timeline

15 August 2020

Primary endpoint
13 December 2020

13 December 2020

Quick facts

Lead sponsor	Stanford University
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	47
Start date	15 August 2020
Primary completion	13 December 2020
Estimated completion	13 December 2020
Sites	1 location across United States

Drugs / interventions tested

Povidone-Iodine 2% — full drug profile →
Povidone-Iodine 0.5% — full drug profile →
Isotonic saline 0.9%

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

Stanford University

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2 Primary · 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.

Baseline

Group	Value	95% CI
Isotonic Saline 0.9%	24.36	± 6.83
Povidone-Iodine 0.5%	26.03	± 4.86
Povidone-Iodine 2%	28.42	± 6.42

Hour 1

Group	Value	95% CI
Isotonic Saline 0.9%	25.71	± 6.87
Povidone-Iodine 0.5%	26.46	± 5.36
Povidone-Iodine 2%	27.45	± 8.09

Day 3

Group	Value	95% CI
Isotonic Saline 0.9%	29.20	± 6.82
Povidone-Iodine 0.5%	36.26	± 21.56
Povidone-Iodine 2%	31.01	± 7.12

Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays Secondary · 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.

Nasal burning or pain - Day 3

Group	Value	95% CI
Isotonic Saline 0.9%	4
Povidone-Iodine 0.5%	2
Povidone-Iodine 2%	13

Nasal burning or pain - Day 5

Group	Value	95% CI
Isotonic Saline 0.9%	2
Povidone-Iodine 0.5%	2
Povidone-Iodine 2%	13

Headaches - Day 3

Group	Value	95% CI
Isotonic Saline 0.9%	3
Povidone-Iodine 0.5%	3
Povidone-Iodine 2%	5

Headaches - Day 5

Group	Value	95% CI
Isotonic Saline 0.9%	2
Povidone-Iodine 0.5%	2
Povidone-Iodine 2%	6

Ear pain - Day 3

Group	Value	95% CI
Isotonic Saline 0.9%	1
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	2

Ear pain - Day 5

Group	Value	95% CI
Isotonic Saline 0.9%	1
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	2

Sneezing - Day 3

Group	Value	95% CI
Isotonic Saline 0.9%	4
Povidone-Iodine 0.5%	1
Povidone-Iodine 2%	9

Sneezing - Day 5

Group	Value	95% CI
Isotonic Saline 0.9%	4
Povidone-Iodine 0.5%	1
Povidone-Iodine 2%	9

Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 Secondary · 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.'

Day 3 - Mild

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Day 3 - Moderate

Group	Value	95% CI
Isotonic Saline 0.9%	1
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Day 3 - Severe

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Day 5 - Mild

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Day 5 - Moderate

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Day 5 - Severe

Group	Value	95% CI
Isotonic Saline 0.9%	1
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 Secondary · 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.'

Day 3 - Mild

Group	Value	95% CI
Isotonic Saline 0.9%	1
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	1

Day 3 - Moderate

Group	Value	95% CI
Isotonic Saline 0.9%	2
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Day 3 - Severe

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Day 5 - Mild

Group	Value	95% CI
Isotonic Saline 0.9%	2
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Day 5 - Moderate

Group	Value	95% CI
Isotonic Saline 0.9%	1
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Day 5 - Severe

Group	Value	95% CI
Isotonic Saline 0.9%	1
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 Secondary · 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.'

Day 3 - Mild

Group	Value	95% CI
Isotonic Saline 0.9%	4
Povidone-Iodine 0.5%	5
Povidone-Iodine 2%	6

Day 3 - Moderate

Group	Value	95% CI
Isotonic Saline 0.9%	1
Povidone-Iodine 0.5%	2
Povidone-Iodine 2%	0

Day 3 - Severe

Group	Value	95% CI
Isotonic Saline 0.9%	1
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Day 5 - Mild

Group	Value	95% CI
Isotonic Saline 0.9%	3
Povidone-Iodine 0.5%	3
Povidone-Iodine 2%	2

Day 5 - Moderate

Group	Value	95% CI
Isotonic Saline 0.9%	2
Povidone-Iodine 0.5%	3
Povidone-Iodine 2%	0

Day 5 - Severe

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2 Secondary · 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.'

Day 3 - Mild

Group	Value	95% CI
Isotonic Saline 0.9%	2
Povidone-Iodine 0.5%	3
Povidone-Iodine 2%	2

Day 3 - Moderate

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	2
Povidone-Iodine 2%	1

Day 3 - Severe

Group	Value	95% CI
Isotonic Saline 0.9%	2
Povidone-Iodine 0.5%	1
Povidone-Iodine 2%	4

Day 5 - Mild

Group	Value	95% CI
Isotonic Saline 0.9%	2
Povidone-Iodine 0.5%	2
Povidone-Iodine 2%	3

Day 5 - Moderate

Group	Value	95% CI
Isotonic Saline 0.9%	1
Povidone-Iodine 0.5%	2
Povidone-Iodine 2%	2

Day 5 - Severe

Group	Value	95% CI
Isotonic Saline 0.9%	1
Povidone-Iodine 0.5%	1
Povidone-Iodine 2%	1

Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2 Secondary · 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.'

Day 3 - Mild

Group	Value	95% CI
Isotonic Saline 0.9%	3
Povidone-Iodine 0.5%	4
Povidone-Iodine 2%	3

Day 3 - Moderate

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	1
Povidone-Iodine 2%	0

Day 3 - Severe

Group	Value	95% CI
Isotonic Saline 0.9%	1
Povidone-Iodine 0.5%	1
Povidone-Iodine 2%	3

Day 5 - Mild

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	1
Povidone-Iodine 2%	2

Day 5 - Moderate

Group	Value	95% CI
Isotonic Saline 0.9%	1
Povidone-Iodine 0.5%	2
Povidone-Iodine 2%	1

Day 5 - Severe

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	1
Povidone-Iodine 2%	2

Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 Secondary · 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.'

Day 3 - Mild

Group	Value	95% CI
Isotonic Saline 0.9%	5
Povidone-Iodine 0.5%	5
Povidone-Iodine 2%	7

Day 3 - Moderate

Group	Value	95% CI
Isotonic Saline 0.9%	3
Povidone-Iodine 0.5%	2
Povidone-Iodine 2%	4

Day 3 - Severe

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Day 5 - Mild

Group	Value	95% CI
Isotonic Saline 0.9%	5
Povidone-Iodine 0.5%	4
Povidone-Iodine 2%	6

Day 5 - Moderate

Group	Value	95% CI
Isotonic Saline 0.9%	2
Povidone-Iodine 0.5%	1
Povidone-Iodine 2%	0

Day 5 - Severe

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 Secondary · 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.'

Day 3 - Mild

Group	Value	95% CI
Isotonic Saline 0.9%	4
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	4

Day 3 - Moderate

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Day 3 - Severe

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Day 5 - Mild

Group	Value	95% CI
Isotonic Saline 0.9%	1
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	2

Day 5 - Moderate

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Day 5 - Severe

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Compliance With Study Drug Administration Secondary · 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.

Group	Value	95% CI
Isotonic Saline 0.9%	11
Povidone-Iodine 0.5%	11
Povidone-Iodine 2%	13
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT) Secondary · 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).

Anosmia - Baseline

Group	Value	95% CI
Isotonic Saline 0.9%	2
Povidone-Iodine 0.5%	4
Povidone-Iodine 2%	5

Anosmia - day 30

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	0

Severe microsmia - baseline

Group	Value	95% CI
Isotonic Saline 0.9%	3
Povidone-Iodine 0.5%	1
Povidone-Iodine 2%	1

Severe microsmia - day 30

Group	Value	95% CI
Isotonic Saline 0.9%	2
Povidone-Iodine 0.5%	1
Povidone-Iodine 2%	1

Moderate microsmia - baseline

Group	Value	95% CI
Isotonic Saline 0.9%	2
Povidone-Iodine 0.5%	2
Povidone-Iodine 2%	2

Moderate microsmia - day 30

Group	Value	95% CI
Isotonic Saline 0.9%	0
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	1

Mild microsmia - baseline

Group	Value	95% CI
Isotonic Saline 0.9%	2
Povidone-Iodine 0.5%	0
Povidone-Iodine 2%	3

Mild microsmia - day 30

Group	Value	95% CI
Isotonic Saline 0.9%	5
Povidone-Iodine 0.5%	2
Povidone-Iodine 2%	3

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Isotonic Saline 0.9%

Serious: 0/15 (0%)

Deaths: 0/15

Povidone-Iodine 0.5%

Serious: 0/15 (0%)

Deaths: 0/15

Povidone-Iodine 2%

Serious: 0/17 (0%)

Deaths: 0/17

Other adverse events (5 terms — click to expand)

Reaction	System	Isotonic Saline 0.9%	Povidone-Iodine 0.5%	Povidone-Iodine 2%
Nasal burning	Respiratory, thoracic and mediastinal disorders	—	—	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—	—	—
Headaches	Nervous system disorders	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—
Nosebleeds	Respiratory, thoracic and mediastinal disorders	—	—	—

Data from ClinicalTrials.gov NCT04347954 adverse events section.

Sponsor's own description

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."

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102
Pharmaceutical assessment of polyvinylpyrrolidone (PVP): As excipient from conventional to controlled delivery systems with a spotlight on COVID-19 inhibition.
Kurakula M, Rao GSNK. · · 2020 · cited 207× · PMID 32905026 · DOI 10.1016/j.jddst.2020.102046
Antimicrobial mouthwashes (gargling) and nasal sprays administered to patients with suspected or confirmed COVID-19 infection to improve patient outcomes and to protect healthcare workers treating them.
Burton MJ, Clarkson JE, Goulao B, Glenny AM, et al · · 2020 · cited 39× · PMID 32936948 · DOI 10.1002/14651858.cd013627.pub2
Use of antimicrobial mouthwashes (gargling) and nasal sprays by healthcare workers to protect them when treating patients with suspected or confirmed COVID-19 infection.
Burton MJ, Clarkson JE, Goulao B, Glenny AM, et al · · 2020 · cited 25× · PMID 32936949 · DOI 10.1002/14651858.cd013626.pub2
Review of the use of nasal and oral antiseptics during a global pandemic.
Stathis C, Victoria N, Loomis K, Nguyen SA, et al · · 2021 · cited 21× · PMID 33464122 · DOI 10.2217/fmb-2020-0286
The Effect of Povidone-Iodine Nasal Spray on Nasopharyngeal SARS-CoV-2 Viral Load: A Randomized Control Trial.
Zarabanda D, Vukkadala N, Phillips KM, Qian ZJ, et al · · 2022 · cited 19× · PMID 34724213 · DOI 10.1002/lary.29935
Antimicrobial mouthwashes (gargling) and nasal sprays to protect healthcare workers when undertaking aerosol-generating procedures (AGPs) on patients without suspected or confirmed COVID-19 infection.
Burton MJ, Clarkson JE, Goulao B, Glenny AM, et al · · 2020 · cited 16× · PMID 32936947 · DOI 10.1002/14651858.cd013628.pub2
COVID-19 Therapeutic Potential of Natural Products.
Low Z, Lani R, Tiong V, Poh C, et al · · 2023 · cited 15× · PMID 37298539 · DOI 10.3390/ijms24119589

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04347954 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stanford University
Last refreshed: 21 October 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04347954.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04347954

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for COVID-19

Other Stanford University trials

Verify against primary sources