person holding mask with gloves on

PIIPPI Trial

Povidone-Iodine Intranasal for Prophylaxis in front-line Physicians/Healthcare Workers and Inpatients during the SARS-CoV2 (COVID19) Pandemic

 

The PIIPPI trial was designed by Drs. Kejner, Ebbitt, and Porterfield after discussion with specialists in critical care, virology, otolaryngology, and endocrinology as well as consultation of the most recent international literature in order to assess the efficacy, safety, and ease of use of a nasal and oral preparation of povidone iodine for health care providers and for inpatients/preoperative patients as a mode of prevention of infection and transmission of the novel coronavirus SARS-CoV-2.  Partnering with the Center for Clinical and Translational Science (CCTS), the University of Kentucky has set up a prospective trial to ensure an evidence-based approach as well as to protect our front-line workers.

FOR PARTICIPANTS: PIIPPI is a prospective, non-randomized trial for front-line healthcare workers, inpatients, and community members that utilizes the antiviral properties of Povidone-Iodine in specific dilution and preparation for prevention of transmission and infection by the novel coronavirus, SARS-CoV2, the virus responsible for the COVID19 pandemic. Participants will be swabbed to assess for active infection and then started on the protocol if eligible and if they have no contraindications to the preparation*.  If there are contraindications, the participant can still be included but will NOT be given the PVIP nasal and oral preparation.  Participants will then be retested at the end of the trial period OR when/if they develop symptoms consistent with COVID19 symptoms.

More information is available about study details here. Please review prior to your intake/eligibility visit.  We will go over the full consent form with you prior to enrollment.  Once you are enrolled, you will undergo a COVID19 test to assess your eligibility.  If you are negative, you will be eligible for continuing in the trial. 

Background and Literature

The COVID-19 pandemic, caused by SARS-CoV-2, has caused massive disruptions and loss of life all over the world. While social distancing, mask wearing, and hand washing have been shown to reduce spread, further research is needed in other ways to protect healthcare workers and the public.

The highest concentration of viral particles resides within the nasopharynx1 and the virus is thought to spread via respiratory droplets with the potential for transmission via inhalation of droplets, contact to the nose and mouth with infected materials, and a potential for airborne transmission2.  Given that frontline workers are involved in high risk procedures including intubation, bronchoscopy, as well as proning patients (which can lead to droplet production) and in some cases are reusing PPE, finding ways to reduce viral load or viral exposure are paramount3,4.

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 MRSA as well as oral preparations in in-vitro studies of SARS-CoV, MERS-CoV, H1N1, and rotavirus with good efficacy5-8.

Due to the known breadth of its antiviral activity and similarities in molecular structure, it can be theoretically extrapolated that PVP-I should have robust activity against SARS-CoV-2.  Eggers et al found that at a concentration of 1% there was a reduction of viral activity of 99.99% in in-vitro assays.  At 2 minutes, a concentration of 0.23% was enough to reduce viral loads appreciably5. 

PVP-I is widely used as an antiseptic and is well-tolerated and has been shown to have little to no effect on mucociliary clearance, olfaction, or thyroid function if iodine holidays are taken9.

RESOURCES:

  1. Zou L, Ruan F, Huang Met al. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med 2020; 382:1177-1179.
  2. van Doremalen N BT, Morris DH, et al. Aerosol and Surface Stability of SARSCoV-2 as Compared with SARS-CoV-1. N Engl J Med 2020.
  3. Zheng MH, Boni L, Fingerhut A. Minimally Invasive Surgery and the Novel Coronavirus Outbreak: Lessons Learned in China and Italy. Ann Surg 2020.
  4. Guidance for ENT during the COVID-19 pandemic. . Available at: https://www.entuk.org/guidanceent-during-covid-19-pandemic.
  5. Eggers M, Koburger-Janssen T, Eickmann M, Zorn J. In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens. Infect Dis Ther 2018; 7:249-259.
  6. Kariwa H, Fujii N, Takashima I. Inactivation of SARS coronavirus by means of povidone-iodine, physical conditions and chemical reagents. Dermatology 2006; 212 Suppl 1:119-123.
  7. Kariwa H, Fujii N, Takashima I. Inactivation of SARS coronavirus by means of povidone-iodine, physical conditions, and chemical reagents. Jpn J Vet Res 2004; 52:105-112.
  8. Kawana R, Kitamura T, Nakagomi Oet al. Inactivation of human viruses by povidone-iodine in comparison with other antiseptics. Dermatology 1997; 195 Suppl 2:29-35.
  9. Panchmatia R, Payandeh J, Al-Salman Ret al. The efficacy of diluted topical povidone-iodine rinses in the management of recalcitrant chronic rhinosinusitis: a prospective cohort study. Eur Arch Otorhinolaryngol 2019; 276:3373-3381.