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NCT04364802: PIIPPI

COVID-19: Povidone-Iodine Intranasal Prophylaxis in Front-line Healthcare Personnel and Inpatients

Completed Phase 2 Results posted Last updated 2 December 2022
What this trial tests

Phase 2 trial testing Povidone-Iodine Nasal Spray and Gargle in COVID-19 in 98 participants. Completed in 28 January 2022.

Timeline
29 April 2020
Primary endpoint
28 January 2022
28 January 2022

Quick facts

Lead sponsorNikita Gupta
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment98
Start date29 April 2020
Primary completion28 January 2022
Estimated completion28 January 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Nikita Gupta — full company profile →

Who can join

Adults 18 to 99, any sex, with COVID-19 or SARS-CoV 2. 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.

Percent of Healthcare Workers Testing Positive for COVID-19. Primary · 3 weeks

Percent of healthcare workers that become positive for COVID-19 during the study.

GroupValue95% CI
Healthcare Workers - Control0
Healthcare Workers - PVP-I0
Percent of Patients Testing Positive for COVID-9. Primary · 2 weeks

Percent of patients that become positive for COVID-19 during the study.

GroupValue95% CI
Inpatients - Control0
Inpatients - PVP-I0
Percent of Community Participants Testing Positive for COVID-9. Primary · 3 weeks

Percent of community participants that become positive for COVID-19 during the study.

GroupValue95% CI
Community - Control0
Community - PVP-I0
PVP-I Ease of Use Secondary · 3 weeks

Patients will rate the ease of use for PVP-I treatment on a scale from 1-5 after the initial use. Lower scores indicate increased ease of use (1="easy") while higher scores indicate increased difficulty (5="impossible").

GroupValue95% CI
Healthcare Workers - PVP-I4.48± 0.80
Inpatients - PVP-I4.43± 0.85
Community - PVP-I4.77± 0.44
PVP-I Comfort Secondary · 3 weeks

Patients will rate the comfort of PVP-I treatment on a scale from 1-5 after the initial use. Lower scores indicate increased comfort (1="not so bad") while higher scores indicate discomfort (5="worst pain of my life").

GroupValue95% CI
Healthcare Workers - PVP-I3.25± 1.33
Inpatients - PVP-I4.00± 1.41
Community - PVP-I3.00± 1.53

Sponsor's own description

Povidone-iodine (PVP-I) is a broad-spectrum antiseptic with activity against bacteria, fungi, and viruses. It has been previously used in both intranasal preparations against Methicillin Resistant Staphylococcus Aureus (MRSA) as well as oral preparations in in-vitro studies of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV), Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV), influenza H1N1, and rotavirus with good efficacy. This study will evaluate the efficacy of PVP-I as prophylaxis in Coronavirus Disease 2019 (COVID19)-negative front-line health care workers, hospital patients, and community members.

Publications & conference data

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

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. Pharmacological strategies to prevent SARS-CoV-2 infection and treat the early phases of COVID-19.
    Scarabel L, Guardascione M, Dal Bo M, Toffoli G. · · 2021 · cited 12× · PMID 33476760 · DOI 10.1016/j.ijid.2021.01.035
  7. Letter to the editor: Possible role of topical povidone iodine in case of accidental ocular exposure to SARS-CoV-2.
    Sarma P, Kaur H, Medhi B, Bhattacharyya A. · · 2020 · cited 6× · PMID 32725405 · DOI 10.1007/s00417-020-04864-9
  8. Clinical trial protocols of repurposed prophylaxis for COVID-19: A review.
    Sallard E, Belhadi D, Lescure FX, Yazdanpanah Y, et al · · 2021 · cited 3× · PMID 33022293 · DOI 10.1016/j.medmal.2020.09.013

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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/NCT04364802.

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