NCT04449965

Povidone-Iodine Rinses in the Management of COVID-19

Terminated EARLY_PHASE1 Last updated 11 July 2022

What this trial tests

EARLY_PHASE1 trial testing Povidone-iodine in Covid19 in 5 participants. Terminated before completion.

Timeline

19 January 2021

Primary endpoint
16 August 2021

16 August 2021

Quick facts

Lead sponsor	St. Paul's Hospital, Canada
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	5
Start date	19 January 2021
Primary completion	16 August 2021
Estimated completion	16 August 2021
Sites	1 location across Canada

Drugs / interventions tested

• Povidone-iodine — full drug profile →
• Placebo

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

St. Paul's Hospital, Canada

Who can join

19 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to determine if Povidone iodine (PVP-I) rinses and throat gargles or a PVP-I gel forming nasal spray compared to a placebo (a treatment that has no physical effect to a person) is an effective treatment for patients diagnosed with COVID-19. These patients have been diagnosed with mild/moderate COVID-19 symptoms and sent home for self-isolation. Patients will be instructed to take either of the two treatments or placebo twice daily for two weeks and have follow up visits 2 and 4 weeks after. The participants will also complete study related procedures such as saliva sample collection, and two questionnaires throughout the study period. The investigators hypothesize that COVID 19 positive participants who use either of the Povidone - Iodine treatment will have a reduction in their viral load, develop a negative oral mucosa sample and improve their clinical symptoms.

Publications & conference data

5 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. 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
3. Potential mouth rinses and nasal sprays that reduce SARS-CoV-2 viral load: What we know so far?
   de Toledo Telles-Araujo G, Caminha RDG, Kallás MS, Sipahi AM, et al · · 2020 · cited 10× · PMID 33263622 · DOI 10.6061/clinics/2020/e2328
4. 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
5. Efficacy of povidone-iodine nasal rinse and mouth wash in COVID-19 management: a prospective, randomized pilot clinical trial (povidone-iodine in COVID-19 management).
   Alsaleh S, Alhussien A, Alyamani A, Alhussain F, et al · · 2024 · cited 4× · PMID 38429662 · DOI 10.1186/s12879-024-09137-y